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COVID-19 clinical trials and supply chain for investigational therapies | DrugPatentWatch

A resource for drug manufacturers, suppliers, distributors, and pharmacies to track and source drugs with potential efficacy against COVID-19.

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Clinical Trials baricitinib bevacizumab chloroquine hydrochloride chloroquine phosphate hydroxychloroquine sulfate ivermectin levofloxacin lopinavir; ritonavir niclosamide Nitric Oxide remdesivir thalidomide

Recent Clinical Trials for COVID-19

Trial ID Title Status Phase Start Date Summary
NCT04353518 Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 Not yet recruiting Phase 3 2020-04-30 This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.
NCT04363840 The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations Not yet recruiting Phase 2 2020-05-01 Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.
NCT04365257 Prazosin to Prevent COVID-19 (PREVENT-COVID Trial) Not yet recruiting Phase 2 2020-04-01 The purpose of this study is to assess the efficacy and safety of prazosin to prevent cytokine storm syndrome and severe complications in hospitalized patients with Coronavirus disease 2019 (COVID-19).
NCT04373824 Max Ivermectin- COVID 19 Study Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study Recruiting N/A 2020-04-25 At present, there are no specific treatments for COVID-19. WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly reported that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect about 5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study rationale is to understand the effect of the drug on eradication of virus.
NCT04392232 A Phase 2 Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection Recruiting Phase 2 2020-05-05 Purpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.
NCT04396067 Combination With Alvelestat and Isotretinoin May Enhances Neutralizing Antibodies in COVID -19 Infected Patients Better Than COVID-19 Inactivated Vaccines Not yet recruiting Phase 2 2020-06-01 Unfortunately, COVID-19 vaccination will be restricted to healthy people with strong immunity and It will not be given to patients with History of contact with a SARS-CoV-2 infection (positive in nucleic acid test). In addition to the COVID-19 viral antigens lead to stimulate antibodies formation of IgM in acute phase and IgG type in chronic phase which is facilitate viral entry and fusion with infected cell through uptake of the virus-IgG complex via the Fc family of receptors and later viral fusion with antigen presenting cells like macrophages, B cells, monocytes via FcR family, and vascular endothelium through the neonatal Fc receptor (nFcR) instead of antibodies induced viral agglutination and this is known as antibody dependent enhancement (ADE)(2). There are various hypotheses on how ADE happens and there is a likelihood that more than one mechanism exists. In one such pathway, some cells of the immune system lack the usual receptors on their surfaces that the virus uses to gain entry, but they have Fc receptors that bind to one end of antibodies. The virus binds to the antigen-binding site at the other end, and in this way gains entry to and infects the immune cell. Dengue virus can use this mechanism to infect human macrophages, if there was a preceding infection with a different strain of the virus, causing a normally mild viral infection to become life-threatening.(3) An ongoing question in the COVID-19 pandemic is whether—and if so, to what extent—COVID-19 receives ADE from prior infection with other coronaviruses. ADE can hamper vaccine development, as a vaccine may cause the production of antibodies which, via ADE, worsen the disease the vaccine is designed to protect against. Vaccine candidates for Dengue virus and feline infectious peritonitis virus (a cat coronavirus) had to be stopped because they elicited ADE.(4) ADE in coronavirus infection can be caused by high mutation rate of the gene that encodes spike (S) protein. A thorough analysis of amino acid variability in SARS-CoV-2 virus proteins, that included the S-protein, revealed that least conservative amino acids are in most exposed fragments of S-protein including receptor binding domain (RBD).(5) High neutrophils in covid-19 infection may be the reason of delayed antibody response and severe complications.Currently, only limited information is available on the host innate immune status of SARS-CoV-2 infected patients. In one report where 99 cases in Wuhan were investigated, increased total neutrophils (38%), reduced total lymphocytes (35%),increased serum IL-6 (52%) and increased c-reactive protein (84%) were observed.25 In a separate report also from Wuhan, it revealed that in 41 patients, increased total neutrophils, decreased total lymphocytes in patients of ICU vs. non-ICU care were found to be statistically different. Increased neutrophils and decreased lymphocytes also correlate with disease severity and death.(10) B cells/plasma cells produce SARS-CoV-2 specific antibodies that may help neutralize viruses.(11)Humoral immune response, especially production of neutralizing antibody, plays a protective role by limiting infection at later phase and prevents reinfection in the future. In SARS-CoV, both T and B cell epitopes were extensively mapped for the structural proteins, S, N, M and E protein.(12) Whether the kinetic/titer of specific antibody correlates with disease severity remains to be investigated.(14)Delayed antibodies response and secretion after covid -19 symptoms onset is responsible for antibody dependent enhancement (ADE) A study shows the first seroconversion day of IgA was 2 days after onset of initial symptoms, and the first seroconversion day of IgM and IgG was 5 days after onset. The positive rate of antibodies in the 183 samples was 98.9%, 93.4% and 95.1%, for IgA, IgM and IgG, respectively. The seroconversion rate for IgA, IgM or IgG was 100% 32 days after symptom onset. According to the cumulative seroconversion curve, the median conversion time for IgA, IgM and IgG was 13, 14 and 14 days, respectively. (6) Because this immune response takes a while to show up, antibody tests will be negative for those newly infected with COVID-19, which is why they're not used for diagnosis. "If it's the beginning of the infection, you don't pick it up, it's something that only develops later," Dr. Melanie Ott, a virologist and immunologist at the Gladstone Institutes So, the principal investigator expects that delayed antibodies response and delayed immunoglobulin class switching are the main reason for antibodies inactivity and non-specificity in the highly mutated COVID-19 infection. Finally, according to this protocol the principal investigator will treat with two potent antibody and immunity inducing drug and the mechanism of action will be discussed in Detailed Description
NCT04475120 Efficacy and Safety of Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients Completed Phase 2/Phase 3 2020-04-15 COVID-19 is considered an ongoing international global health problem which already caused 12 million confirmed cases. No specific effective treatment has been identified so far, and available supportive therapies are intended just to severe patients. Asymptomatic and mildly symptomatic patients remain a transmission reservoir, with possible evolution to the most severe disease form, without a clear treatment indication. Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted by exocrine glands and neutrophils and present in all human secretion. The pleiotropic activity of Lf is mainly based on its four different functions: chelate two ferric iron per molecule, interact with anionic molecules, enter inside nucleus and modulate iron homeostasis. The ability to chelate two ferric ions per molecule is associated to the inhibition of reactive oxygen species formation as well as this sequestration of iron, pivotal for bacterial and viral replication, is at the basis of its antibacterial and antiviral activity. Moreover, Lf exerts its antiviral activity against the majority of the tested viruses by binding to heparan sulphate, while against few viruses by interacting with surface components of viral particles. The capability of Lf to exert antiviral activity, by binding to host cells or viral particles or both, strengthens the idea that this glycoprotein is "an important brick in the mucosal wall, effective against viral attacks". Lang and colleagues investigated the role of Lf in the entry of SARS pseudovirus into Myc cells. Their results reveal that Lf was able to block the binding of the spike protein to host cells, indicating that Lf exerted its inhibitory function at the viral attachment stage. The current accepted model suggests that Lf could block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which mediate the transport of extracellular virus particles from the low affinity anchoring sites to the high affinity specific entry as ACE-2. We performed a prospective, interventional pilot study to assess the efficacy of liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19 asymptomatic patients. Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral and intra-nasal use.
NCT04510194 MET-Covid Trial - METformin for Prevention and Outpatient Treatment of COVID-19 Not yet recruiting Phase 2/Phase 3 2020-09-01 The purpose of this trial is to: 1. Determine whether metformin can reduce the severity of COVID-19 disease; 2. Determine whether metformin can prevent symptomatic COVID-19 disease; 3. Determine whether metformin can prevent SARS-CoV-2 infection (seroconversion of SARS-CoV2 antibody tests or PCR positivity)
NCT04521322 Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease Recruiting Phase 4 2020-07-24 Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray. For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease. Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.
NCT04570449 Pilot Randomized Controlled Trial: Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19) Not yet recruiting Early Phase 1 2020-09-01 The current research is a pilot study to determine the feasibility of recruiting and retaining 40 participants diagnosed with COVID-19. The purpose is to observe the early use of fluoxetine (commonly known as Prozac) to reduce the severity of the COVID-19 illness. Fluoxetine is a drug that has been approved by the U.S. Food and Drug Administration (FDA) since 1987 for various mental health disorders.
NCT04577378 Efficacy and Safety of Drug Combination Therapy of Isotretinoin and Some Antifungal Drugs as A Potential Aerosol Therapy for COVID-19 : An Innovative Therapeutic Approach COVID-19 Not yet recruiting Phase 2 2020-10-20 Efficacy and safety of Drug combination therapy of Isotretinoin and some Anti fungal Drugs as A potential Aerosol therapy for COVID-19 : An innovative therapeutic approach The pandemic of COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 2,000,000 people causing over 150,000 deaths.It hasno currently approved treatments.. Airborne SARS-CoV-2 infections in humans initiate from the virus entering nasal and airway epithelial cells through binding to angiotensin-converting enzyme 2 (ACE2). TMPRSS2, a cellular protease that activates the SARS-CoV-2 spike protein, colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane. In the lungs, SARS-CoV-2 infects type I and type II alveolar epithelial cells, as well as alveolar macrophages that are among the first producers of pro-inflammatory cytokines. As key components of the immediate antiviral response, type I interferons (here after referred to as IFNs) are crucial for restricting viral replication and spread, through autocrine and paracrine type I IFN receptor (IFNAR) signalling. However, minimal amounts of IFNs have been detected in the peripheral blood or lungs of patients with severe COVID-19 In a mouse model of SARS-CoV infection, local IFN responses in the lungs were delayed relative to peak viral replication, which impeded virus clearance and was associated with the development of CRS . SARS-CoV-2 ORF3b is a potent interferon inhebitor and antagonist Here, we review the molecular mechanisms by which Retinoic acid (isotretinoin) and antifungal drugs can cooperate to induce interferon in covid-19 infected patients A study reported that 13 Cis retinoic acid induced significant upregulation of toll-like receptor 3 resulting in an immune response to dsRNA intermediate which can be partially generated during CoV-2 replication . TLR3 sensitized by dsRNA and cascades of signaling pathways (Interferon-regulatory factor 1 (IRFs) and Nuclear factor-κB (NFκB) activation, respectively) are activated to produce type I interferons. The production of type I IFNs is important to enhance the release of antiviral proteins for the protection of uninfected cells. RA can be generated in multiple forms as all-trans, 9-cis,and 13-cis retinoic acid. A study reported that Retinoic acid induces directly the expression of two transcription factors, Stat1 and IRF-1 which play central roles in the IFN signal transduction. In addition, RA induces IFN-a synthesis, IFNs can serve as the first line of immune defense against viral infections. IFNs are very powerful cytokines, which play a key role in combatting pathogenic infections by controlling inflammation and immune response by directly inducing antipathogen molecular countermeasures. There are three classes of IFNs: type I, type II, and type III. Antifungal drug. Fluconazol or itraconazol can inhibit cytochrome P450 enzymes, especially cype 26 which control retinoic acid concentration into human cells enhance both isotretinoin effect and Concentrations in Target Tissues This in turn lead to hyper interferon induction and synthesis in case of COVID-19. Also a study demonstrated that isotretinoin can be given as aerosolized via inhalation rout without any damage in lung cells. Repeated high doses of 13 cis retinoic by inhalation resulted in moderate loss of body weight, but microscopic investigation of ten tissues including lung and oesophagus did not detect any significant aerosol-induced damage therefore inhaled isotretinoin might provide sufficient drug to the target cells in lung for efficacy while avoiding systemic toxicity. In conclusion,isotretinoin therapy has furthermore a proven anti-inflammatory, anti-platelet and fibrinolytic activities which may protect patients infected with covid-19 from widespread blood clots. From this point, we suggest that isotretinoin will be the immunity passport" in the context of COVID-19.
NCT04627467 Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID) Active, not recruiting Phase 2 2020-03-28 The purpose of this study is to assess the efficacy and safety of chloroquine prophylaxis on the incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections in healthcare workers exposed to patients with confirmed Coronavirus Disease 2019 (COVID-19)
NCT04668950 Fluvoxamine for Early Treatment of Covid-19: a Fully-remote, Randomized Placebo Controlled Trial (Stop Covid 2) Not yet recruiting Phase 3 2020-12-01 The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. People around the United States and Canada can participate.
NCT04695704 Montelukast Clinical Trial in Mild-moderate Respiratory Symptoms in Patients With Long-COVID (ESPERANZA COVID) Not yet recruiting Phase 3 2021-04-01 Recently, a new clinical presentation called "long covid" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to evaluate the efficacy of Montelukast in improving the quality of life associated with respiratory symptoms in patients with persistent COVID-19 symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.
NCT04273529 The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia Not yet recruiting Phase 2 2020-02-20 In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.
NCT04273581 The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19 Not yet recruiting Phase 2 2020-02-18 In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.
NCT04275414 Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia Recruiting Phase 2/Phase 3 2020-02-01 The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental symptoms and usually presents in severe and critical coronavirus disease (COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is considered as the most potent vascular permeability inducers. Numerous studies have revealed that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab, an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary edema.
NCT04278963 Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19 Not yet recruiting Phase 2/Phase 3 2020-02-01 In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia caused by CoVID-19, and the number of cases of infection with CoVID-19 identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally. Given no specific antiviral therapy for CoVID-19 infection and the availability of Yinhu Qingwen Decoction as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this randomized,three-arm controlled, single-blind trial will evaluate the efficacy and safety of Yinhu Qingwen Decoction in patients hospitalized with mild or common CoVID-19 respiratory disease.
NCT04280705 Adaptive COVID-19 Treatment Trial Not yet recruiting Phase 2 2020-03-12 This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. Randomization will be stratified by: 1) site and 2) severity of illness at enrollment, severe disease (requiring mechanical ventilation or oxygen, a SpO2 /= 24 breaths/min)) or mild-moderate disease (SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen)). Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15, and 29. All subjects will undergo a series of efficacy, safety, and laboratory assessments. The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19.
NCT04285190 The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19 Not yet recruiting N/A 2020-02-26 This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
NCT04287686 Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 Not yet recruiting N/A 2020-02-01 This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.
NCT04290871 Nitric Oxide Gas Inhalation for Severe Acute Respiratory Distress Syndrome in COVID-2019. Not yet recruiting Phase 2 2020-03-01 We will enroll 104 patients with a confirmed diagnosis of COVID-19. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or placebo. ICU Standards of care will be the institution"s own protocols (such as ventilation strategies and use and dose of antivirals and antimicrobials, steroids, inotropic and vasopressor agents).
NCT04304053 Treatment of Mild Cases and Chemoprophylaxis of Contacts as Prevention of the COVID-19 Epidemic Not yet recruiting Phase 2/Phase 3 2020-03-15 The investigators plan to evaluate the efficacy of the 'test and treat' strategy of infected patients and prophylactic chloroquine treatment to all contacts. The strategy entails decentralized COVID-19 testing and starting antiviral darunavir/cobicistat plus chloroquine treatment immediately in all who are found to be infected. As viral loads decline to undetectable levels, the probability of onward transmission is reduced to very low levels. Such evaluation will require prospective surveillance to assess the population-level effect of transmission prevention. Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.
NCT04305457 Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 Infection Not yet recruiting Phase 2 2020-03-01 The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
NCT04310865 Yinhu Qingwen Granula for the Treatment of Severe CoVID-19 Not yet recruiting Phase 2/Phase 3 2020-03-20 In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia caused by CoVID-19, and the number of cases of infection with CoVID-19 identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally.Given no specific antiviral therapy for CoVID-19 infection and the availability of Yinhu Qingwen Granula as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this adaptive, randomized,double-blind,controlled trial will evaluate the efficacy and safety of Yinhu Qingwen Granula in patients hospitalized with severe CoVID-19.
NCT04311697 Intravenous Aviptadil for COVID-19 Associated Acute Respiratory Distress Not yet recruiting Phase 2 2020-04-01 Novel Corona Virus (COVID-19) is known to cause Acute Respiratory Distress Syndrome, that results in mortality in 35% - 50% of affected patients, despite intensive care and mechanical ventilation. Patients with COVID-19 induced Acute Respiratory Distress Syndrome who are admitted for intensive care including endotracheal intubation and mechanical ventilation will be treated with Aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP) and compared to historical controls. Patients will be randomized to intravenous Aviptadil with escalation to nebulized Aviptadil vs. nebulized Aviptadil with escalation to intravenous Aviptadil.
NCT04312243 NO Prevention of COVID-19 for Healthcare Providers Not yet recruiting Phase 2 2020-03-20 Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 260 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.
NCT04315896 Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial) Not yet recruiting Phase 3 2020-03-23 Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.
NCT04315948 Trial of Treatments for COVID-19 in Hospitalized Adults Not yet recruiting Phase 3 2020-03-01 This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in up to 50 sites globally with multiple sponsors. Adults (≥18 year-old) hospitalized for COVID- 19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring mechanical ventilation and/or supplemental oxygen will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC + Lopinavir/Ritonavir plus interferon ß-1a. Randomization will be stratified by site and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.
NCT04317040 CD24Fc as a Non-antiviral Immunomodulator in COVID-19 Treatment Not yet recruiting Phase 3 2020-05-01 The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19 and absolute lymphocyte counts ≤ 800/mm^3 in peripheral blood. Arm A: CD24Fc/Best Available Treatment Arm B: placebo/ Best Available Treatment CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. Serum cytokine IL-6 level will be used as stratification factor in randomization. All subjects will be treated with the best available treatment. The follow up period is 15 days.
NCT04318015 Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial) Not yet recruiting Phase 3 2020-04-01 Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
NCT04318444 Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19) Not yet recruiting Phase 2/Phase 3 2020-03-01 The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.
NCT04320277 Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study. Recruiting Phase 3 2020-03-16 There is no specific antiviral treatment recommended for COVID-19, and no vaccine is currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with excellent results in terms of clinical response and a good safety profile. Since baricitinib does not interact with antivirals due to its prevalent renal elimination, it may be used in combination.The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.
NCT04323631 Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death Not yet recruiting Early Phase 1 2020-03-01 This is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.
NCT04324463 Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial Not yet recruiting Phase 3 2020-04-01 ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
NCT04325061 Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19 Not yet recruiting Phase 4 2020-04-01 Background: There are no proven therapies specific for Covid-19. The full spectrum of Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial. Methods: This is an internationally (Spain, Canada, China, USA) randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care, or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.
NCT04325633 Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection Not yet recruiting Phase 3 2020-03-27 The symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.
NCT04326036 Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection Active, not recruiting Early Phase 1 2020-03-25 COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
NCT04326920 Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC) Recruiting Phase 4 2020-03-24 Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.
NCT04327206 BCG Vaccination to Protect Healthcare Workers Against COVID-19 Not yet recruiting Phase 3 2020-03-30 Open label, two-group, phase III randomised controlled trial in up to 4170 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.
NCT04327505 Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19 Not yet recruiting Phase 2/Phase 3 2020-04-25 We hypothesize that hyperbaric oxygen (HBO) is safe for patients with COVID-19 and that HBO reduces the inflammatory reaction in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Also known as SARS-CoV-2, COVID-19 is declared a pandemic by World Health Organization (WHO). No specific treatment has been successful as of March 2020. Mortality rates in patients that develop ARDS is extremely high, 61.5-90%, almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 is associated with pulmonary edema, rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators have been tried in experimental settings without proven clinical benefits. HBO significantly reduces inflammatory cytokines and and oedema in other clinical settings. HBO has been used for almost a century, nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials show beneficial effects in variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events and extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.
NCT04328285 Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers Not yet recruiting Phase 3 2020-03-30 Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic. In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients. As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers. The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo. Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
NCT04328493 The Vietnam Chloroquine Treatment on COVID-19 Not yet recruiting Phase 2 2020-04-01 COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19. We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. The study is funded and leaded by The Ministry of Health, Vietnam.
NCT04328961 Hydroxychloroquine for COVID-19 PEP Not yet recruiting Phase 1 2020-03-01 This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
NCT04329572 Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Hospitalized Patients With Moderate to Severe COVID-19 Not yet recruiting Early Phase 1 2020-04-03 This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
NCT04330638 Treatment of COVID-19 Patients With Anti-interleukin Drugs Not yet recruiting Phase 4 2020-04-01 The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome
NCT04330690 Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial Active, not recruiting Phase 2 2020-03-18 This study is an adaptive, randomized, open-label, controlled clinical trial. Subjects will be randomized to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19. Lopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first
NCT04331470 Evaluation of Efficacy of Levamisole and Formoterol+Budesonide in Treatment of COVID-19 Not yet recruiting Phase 2/Phase 3 2020-03-31 New Corona virus (COVID-19) has made a horrible situation for all of the countries. This disease is not only a health problem but also economy, culture and the whole entity of the countries is under attack by the virus. This disease seems to affect the body in two different pathology pathways. From one side virus can decrease activity of immune system in the blood stream and whole body and from other side it can attack the respiratory cells. Tissue biopsy shows that immune cells penetrate into the Lung tissue and we have accumulation and over activity of Immune cells in the lung. This inflammation in respiratory tract probably is the major cause of Cytokine storm and release of TNF-α and IL-6 into the blood. It seems that by three strategy disease can be treated. 1- By using systemic immune simulators. 2- By using topical anti-inflammatory drug in the respiratory system (Steroids or NSAIDs) 3- By inhibition of replication of the virus in the attacked cells.
NCT04331665 Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia Not yet recruiting N/A 2020-04-06 The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug. This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.
NCT04332107 Azithromycin for COVID-19 Treatment in Outpatients Nationwide Not yet recruiting Phase 3 2020-04-01 This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with mild/moderate symptomatic COVID-19 with a recent positive SARS-CoV-2 test.
NCT04332666 Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial Not yet recruiting Phase 2/Phase 3 2020-03-31 Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.
NCT04332991 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease Not yet recruiting Phase 3 2020-04-01 ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
NCT04333472 Piclidenoson for Treatment of COVID-19 Not yet recruiting Phase 2 2020-04-06 Patients with documented COVID-19 infection will be randomized 1:1 to receive Piclidenoson 2 mg Q12H orally with standard care (intervention arm) or standard care alone (control arm).
NCT04333628 Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 Not yet recruiting Phase 2/Phase 3 2020-04-01 19 COVID is a deadly viral disease that has been spreading around the world for several months, and is caused by a CORONA family virus (COVID-19). Following IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses, this drug has been used empirically for COVID-19 patients and is currently recommended in Israel for the treatment of intermediate and severity disease. The mechanism of action of chloroquine is in part by inhibiting the virus distribution, and changing the intracellular acidity, the virus distribution site. The intracellular chloroquine concentration is determined by a pump called PGP that removes the drug from the cell and is activated by the drug. In the treatment of malaria, the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher, and therefore the logic to examine this issue in COVID-19 treatment. The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening.
NCT04334460 Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects Not yet recruiting Phase 2 2020-05-01 BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9 that is selective over the cathepsins as well as other protease families, displays good metabolic stability and permeability, oral bioavailability and low cytochrome P450 (CYP) inhibition. It is under development for the treatment of coronavirus disease-19 (COVID-19) resulting from infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV2), where there is significant unmet medical need.
NCT04334512 A Study of Quintuple Therapy to Treat COVID-19 Infection Not yet recruiting Phase 2 2020-04-01 This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
NCT04334967 Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Enrolling by invitation Phase 4 2020-03-30 This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19
NCT04335071 Multicenter, Double-blind, Randomized Controlled Trial of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19) Not yet recruiting Phase 2 2020-04-01 The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the immune system to the virus, causing a cytokine storm with features of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and low platelets. There is increasing data that cytokine-targeted biological therapies can improve outcomes in CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been approved for the treatment of CRS and is used in patients with MAS. Based on these data, it is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS and ARDS. The overall purpose of this study is to evaluate whether treatment with TCZ reduces the severity and mortality in patients with COVID-19.
NCT04335084 A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection Not yet recruiting Phase 2 2020-04-01 This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent infection with COVID-19
NCT04335123 Study of Open Label Losartan in COVID-19 Recruiting Phase 1 2020-03-25 This is an open label, phase 1 clinical trial to evaluate the safety of losartan in respiratory failure due to COVID-19. Briefly, 50 patients with COVID-19 and respiratory failure who meet eligibility criteria and agree to participation in the study will be placed on losartan 25 mg daily on study day 0. If parameters are met the dose of losartan will be increased to 50 mg daily on study day 3. Participants will continue losartan until they experience resolution of respiratory failure (normal oxygen levels on room air), are discharged from the hospital, meet stoppage criteria (detailed below) or complete 14 days of therapy. Patients and/or surrogate decision maker who do not give consent to treatment will be asked to allow collection of data from their medical record for use as a control group.
NCT04335201 Defibrotide in COVID-19 Pneumonia Not yet recruiting Phase 2 2020-04-06 Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele Scientific Institute included in the institutional observational study. A sample of 50 patients with COVID-19 pneumonia will allow to detect an absolute reduction in the rate of Respiratory-failure at day+14 after treatment of 20%, assuming that the actual rate of failure in the corresponding not treated patients is 70% (alpha=5%, power=90%, two-sided test). The software PASS15 was used for calculations. The study will also include a parallel retrospective group of temporally concomitant patients from IRCCS, San Raffaele Scientific Institute, who did not receive an experimental treatment and who are enrolled in an already IRB approved observational study
NCT04336904 Clinical Study To Evaluate The Performance And Safety Of Favipiravir in COVID-19 Active, not recruiting Phase 3 2020-03-25 This study evaluates treatment with Favipiravir combined with supportive care for adult patients with COVID-19-moderate type.
NCT04337918 Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection Not yet recruiting Phase 2 2020-04-06 This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.
NCT04338802 Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19 Not yet recruiting Phase 2 2020-04-02 This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
NCT04338828 Nitric Oxide Inhalation Therapy for COVID-19 Infections in the ED Not yet recruiting Phase 2 2020-04-01 The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.
NCT04338906 Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19 Not yet recruiting Phase 4 2020-06-01 Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.
NCT04338958 Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation Not yet recruiting Phase 2 2020-05-01 RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.
NCT04339426 Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection Not yet recruiting N/A 2020-04-01 This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.
NCT04339816 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial Not yet recruiting Phase 3 2020-04-20 Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.
NCT04340232 Safety and Efficacy of Baricitinib for COVID-19 Not yet recruiting Phase 2/Phase 3 2020-04-01 This study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.
NCT04340349 Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals Not yet recruiting Early Phase 1 2020-04-10 This study will investigate the security and efficacy of a daily low dose of hydroxychloroquine, in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City.
NCT04340544 Hydroxychloroquine for the Treatment of Mild COVID-19 Disease Not yet recruiting Phase 3 2020-04-10 The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 [1] replication and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine. The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.
NCT04341038 Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury Recruiting Phase 3 2020-04-01 The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.
NCT04341441 Will Hydroxychloroquine Impede or Prevent COVID-19 Not yet recruiting Phase 3 2020-04-07 The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Metro Detroit, Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.
NCT04341493 Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19 Recruiting Phase 4 2020-04-06 Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.
NCT04341688 A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load in COVID-19 Patients Not yet recruiting N/A 2020-07-01 Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Owing to the aerosol producing nature of the dental profession, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-pharynx is likely to reduce the viral load. This topical therapy is speculated to substantially reduce the transmission of infection in micro-aerosol generated in the dental practice. Such topical anti-viral therapy could also help to improve the overall symptoms of the patient.
NCT04342169 University of Utah COVID-19 Hydrochloroquine Trial Not yet recruiting Phase 2 2020-04-14 A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.
NCT04342221 Hydroxychloroquine for COVID-19 Recruiting Phase 3 2020-03-29 The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine. We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.
NCT04342663 A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection Not yet recruiting Phase 2 2020-04-10 The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.
NCT04342689 The Role of Resistant Starch in COVID-19 Infection Not yet recruiting Phase 3 2020-05-01 This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.
NCT04343001 Coronavirus Response - Active Support for Hospitalised Covid-19 Patients Not yet recruiting Phase 3 2020-04-01 The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults hospitalised with suspected or confirmed acute COVID-19 infection.
NCT04343248 A Randomized, Double-Blind, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF) Not yet recruiting Phase 3 2020-04-30 Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
NCT04343677 Military COVID-19 Hydroxychloroquine Pre-exposure and Post-exposure Prophylaxis Study Not yet recruiting Phase 2 2020-04-01 There is significant interest throughout the United States in performing a well-designed study to evaluate whether there is value in using Hydroxychloroquine or Chloroquine as a pre-exposure prophylaxis or post-exposure prophylaxis regimen for COVID-19 patients and at risk personnel. We have designed a prospective double blinded randomized controlled clinical trial to answer just this question. The study will consist of 4 arms: 1. A placebo control arm of 450 patients 2. A low dose prophylaxis arm of 450 patients treated with 200mg Hydroxychloroquine daily 3. A high dose prophylaxis arm of 450 patients treated with 400mg Hydroxychloroquine daily 4. A post-exposure arm of 100 patients treated with 400mg Hydroxychloroquine daily for 7 days.
NCT04343768 An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial Not yet recruiting Phase 4 2020-04-10 The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04343976 Pegylated Interferon Lambda Treatment for COVID-19 Not yet recruiting Phase 2 2020-05-01 Prospective randomized, two-stage trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs. standard of care in up to 40 subjects (20 inpatient and 20 outpatient) with COVID-19 infection.
NCT04343989 A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection Recruiting Phase 2 2020-03-31 In this study clazakizumab will be administered to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1:1 ratio to three study arms that will receive clazakizumab at a dose of 12.5 mg, 25 mg or placebo
NCT04344184 Early Infusion of Vitamin C for Treatment of Novel COVID-19 Acute Lung Injury (EVICT-CORONA-ALI) Not yet recruiting Phase 2 2020-04-22 This study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury caused by the SARS-Cov-2.
NCT04344236 Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19 Recruiting Phase 2 2020-04-09 For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or povidone-iodine or nothing (control group) as well as spray the same solution in their nose four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7 days and viral loads will be measured.
NCT04344444 Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease Recruiting Phase 3 2020-04-10 This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.
NCT04344457 Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19 Not yet recruiting Phase 1/Phase 2 2020-04-16 Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona. This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2
NCT04344730 Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia Recruiting N/A 2020-04-10 The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
NCT04345289 Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia Not yet recruiting Phase 3 2020-04-20 CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
NCT04345419 A Real-life Experience on Treatment of Patients With COVID 19 Not yet recruiting Phase 2/Phase 3 2020-04-15 COVID 19 treatment using Chloroquine with or without Azithromycin, Faviprevir, Nitazoxanide, Ivermectin.
NCT04345692 A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients Recruiting Phase 3 2020-03-26 This study is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded comparison between open label hydroxychloroquine and usual care. The course of treatment (HCQ) is five days. Participants will be followed to study day 28.
NCT04347174 A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients Not yet recruiting N/A 2020-04-20 The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
NCT04347226 Anti-Interleukin-8 (Anti-IL-8) for Cancer Patients With COVID-19 Not yet recruiting Phase 2 2020-04-01 This study is for cancer patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can help improve the health condition of cancer participants infected with COVID-19. This is the first in-human study of this investigational product specifically in cancer patients with severe COVID-19. Currently there are no FDA approved medications that improve the chance of survival in patients diagnosed with COVID-19. However there are usual treatments currently being used to help treat COVID-19 patients and BMS-986253 will be compared to these standard of care treatments in this study.
NCT04347382 Efficacy of Nigella Sativa and Natural Honey Against COVID-19: an RCT Recruiting Phase 3 2020-04-15 To evaluate the effectiveness of Nigella Sativa/ Black Cummins (2gm seed powder in a capsule orally) and 30ml of honey stirred in 250ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care vs standard hospital care alone with placebo capsule and 250ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).
NCT04348071 Safety and Efficacy of Ruxolitinib for COVID-19 Not yet recruiting Phase 2/Phase 3 2020-04-01 This study plans to learn more about the effects of a medicine called ruxolitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.
NCT04348305 Hydrocortisone for COVID-19 and Severe Hypoxia Not yet recruiting Phase 3 2020-04-15 We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.
NCT04348409 Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19 Not yet recruiting N/A 2020-04-12 This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.
NCT04348435 A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19 Enrolling by invitation Phase 2 2020-04-23 Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
NCT04348474 Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19 Not yet recruiting Early Phase 1 2020-04-20 This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
NCT04349241 Efficacy and Safety of Favipiravir in Management of COVID-19 Not yet recruiting Phase 3 2020-04-20 Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.
NCT04349371 Saved From COVID-19 Recruiting Phase 2 2020-04-01 The primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status.
NCT04349410 The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol Enrolling by invitation Phase 2/Phase 3 2020-04-11 Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body - at the tissue level. The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) - along with the associated submitted patent applications ruled to be covered under #9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases. The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives.
NCT04349592 Qatar Prospective RCT Of Therapy Eliminating Covid Transmission Not yet recruiting N/A 2020-04-14 Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
NCT04349631 A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) to Provide Protection Against COVID-19 Enrolling by invitation Phase 2 2020-04-16 Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
NCT04350320 Randomized Open-blind Controlled Trial to Study the Benefit of Colchicine in Patients With COVID-19 Not yet recruiting Phase 3 2020-04-20 COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. We present a randomized clinical trial, controlled, open-label and pragmatic, including COVID-19 patients requiring hospitalization but no intensive care yet. Colchicine will be started within the first 48 hours and then administered for four weeks using a descending dose. The benefit will be study in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is widely accessible which would help to prevent the inflammatory complications associated with COVID-19.
NCT04350580 IgIV in COVID-19 Related ARds Not yet recruiting Phase 3 2020-04-01 As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with acute renal failure. No specific pharmacological treatment is available yet. The lung lesions are related to both the viral infection and to an intense inflammatory reaction. Because of it's action, as an immunomodulatory agent that can attenuate the inflammatory reaction and also strengthen the antiviral response, it is proposed to evaluate the effectiveness and safety of intravenous immunoglobulin administration (IGIV) in patients developing ARDS post-SARS-CoV2. IGIV modulates immunity, and this effect results in a decrease of pro-inflammatory activity, key factor in the ARDS related to the COVID-19. It should be noted that IGIV is part of the treatments in various diseases such as autoimmune and inflammatory diffuse interstitial lung diseases. In addition, they have been beneficial in the post-influenza ARDS but also have been in 3 cases of post-SARS-CoV2 ARDS. IGIV is a treatment option because it is well tolerated, especially concerning the kidney. These elements encourage a placebo-controlled trial testing the benefit of IGIV in ARDS post-SARS-CoV2.
NCT04350593 Dapagliflozin in Respiratory Failure in Patients With COVID-19 Recruiting Phase 3 2020-04-15 This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US and other countries with high prevalence of COVID-19. The study is evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily for 30 days in addition to background local standard of care therapy, in reducing disease progression, complications, and all-cause mortality.
NCT04350671 Interferon Beta 1a in COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Enrolling by invitation Phase 4 2020-04-15 The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04350684 Umifenovir in COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Enrolling by invitation Phase 4 2020-04-15 The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04351152 Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia Not yet recruiting Phase 3 2020-05-01 The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.
NCT04351295 Efficacy of Faviprevir in COVID-19 Treatment Not yet recruiting Phase 2/Phase 3 2020-04-17 Faviprevir in COVID-19 treatment
NCT04351347 The Efficacy of Ivermectin and Nitazoxanide in COVID-19 Treatment Not yet recruiting Phase 2/Phase 3 2020-04-17 Efficacy of Ivermectin and Nitazoxanide in COVID-19 treatment
NCT04351620 High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19 Recruiting Phase 1 2020-04-01 This study aims to examine the tolerability of high dose hydroxychloroquine in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.
NCT04352400 Efficacy of Nafamostat in Covid-19 Patients (RACONA Study) Not yet recruiting Phase 2/Phase 3 2020-04-01 RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung function deterioration and need for intensive care admission in COVID-19 patients. Design: Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate (administered intravenously) on top of best standard of care. Primary outcome measures: the time-to-clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven category ordinal scale or live discharge from the hospital, whichever comes first.
NCT04352465 Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients Not yet recruiting Phase 1/Phase 2 2020-05-01 The aim of this study is to evaluate the efficacy and safety of MTX-loaded nanoparticles in three different doses to treat severe COVID-19 patients.
NCT04352933 PROLIFIC ChemoprophylaxisTrial (COVID-19) Not yet recruiting Phase 3 2020-04-01 The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2 coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability of the entire National Health Service (NHS) to cope with the increased demand. The availability of personal protective equipment is limited and reports of high risk procedures such as aerosol generating procedures (e.g. intubation for the sickest patients) is a source of great concern for infection transmission. Frontline NHS staff with direct patient contact have the highest likelihood of exposure to SARS-CoV-2 and development of COVID-19 disease. Efforts to protect these workers from development of COVID-19, using drugs to prevent the disease, require urgent evaluation.
NCT04352946 HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial Not yet recruiting Phase 3 2020-04-24 This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 60 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).
NCT04353037 PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine Recruiting Phase 2 2020-04-07 Our hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. We believe there is enough information to launch a clinical trial of hydroxychloroquine for COVID-19.
NCT04353180 Assessment the Activity Value of Retinoic Acid in the Treatment of COVID-19 Recruiting Phase 3 2020-04-01 ( Research protocol byAssistant researcher Mahmoud Ramadan Abdel-Hamid EL-kazzaz (Corresponding Author and Principal Investigator) Department of chemistry and biochemistry, Master of Virology and Molecular biology , Faculty of Science, Damietta University Mail:mahmoudramadan2051@yahoo.com Tel:00201090302015) _____________________________________________________________________________________________ _________________________________________________ Severe acute respiratory syndrome (SARS) is an infectious and highly contagious disease that is caused by SARS coronavirus (SARS-CoV) and for which there are currently no approved treatments. Here, the investigator reports according to previous research studies that retinoic acid could strongly affect both inflammation and cellular viral entry in severe acute respiratory syndrome (SARS-CoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection via modulating and reducing cytokine storm factors (IL- 6,IL-1 and tumor necrosis factors alpha ) which are over expressed in COVID 2019 infection and contribute to disease progression and poor outcomes, poor prognosis and bad survival in patients infected with severe acute respiratory syndrome(SARS-CoV). And also, via blocking viral entry by inhibition of (Serine protease 2) rather than inhibition of ACE2 and AT1 protein and Ang II-mediated intracellular calcium release pathway which is responsible for SARS-CoV-2 cell fusion and entry.Retinoic acid which induce FOXP3 and CD8+,CD4+,CD25+,FOXP3+ Tregs which were dramatically reduced in COVID-19 patients to exert its anti-inflammatory effect protecting lung cell and neural cells from the inflammatory and destructive effect of IL-6. In addition to inducing retinoic acid inducible gene-1 (RIG-1) and endosomal toll-like receptor 3 (TLR3) as pathogen-associated molecular patterns. This recognition resulted in the formation of type-1 interferon (IFN1). As an evasion mechanism, virus synthesize proteins that hinder the production of IFN type1 in COVID 2019 infection .
NCT04353271 Trial of Hydroxychloroquine In Covid-19 Kinetics Recruiting Phase 2/Phase 3 2020-04-15 To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.
NCT04353336 Efficacay of Chloroquine in COVID-19 Treatment Not yet recruiting Phase 2/Phase 3 2020-04-17 Chloroquine in COVID-19 treatment
NCT04353596 Stopping ACE-inhibitors in COVID-19 Not yet recruiting Phase 4 2020-04-15 ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients
NCT04354389 DAS181 for STOP COVID-19 Not yet recruiting Phase 2/Phase 3 2020-04-25 It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.
NCT04354441 Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women Not yet recruiting Phase 2 2020-05-01 COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.
NCT04354805 Administration of Chloropromazine as a Treatment for COVID-19 Not yet recruiting Phase 1/Phase 2 2020-05-01 In this study, defined cases of COVID-19 confirmed with PCR, with a mild, moderate or severe pneumonia will be treated with chlorpromazine IV injection. The improvement in clinical & laboratory manifestations will be evaluated in treated patient compared to control group.
NCT04355247 Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm Recruiting Phase 2 2020-04-14 This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.
NCT04355429 Efficacy of Captopril in Covid-19 Patients With Severe Acute Respiratory Syndrome (SARS) CoV-2 Pneumonia (CAPTOCOVID) Not yet recruiting Phase 2 2020-04-13 Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.
NCT04355936 Telmisartan for Treatment of COVID-19 Patients Recruiting Phase 2 2020-04-01 In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic. This new disease was named COVID-19 and the causative virus SARS-CoV-2. The SARS-CoV-2 virus, enters the airway and binds, by means of the S protein on its surface to the membrane protein ACE2 in type 2 alveolar cells. The S protein-ACE2 complex is internalized by endocytosis leading to a partial decrease or total loss of the enzymatic function ACE2 in the alveolar cells and in turn increasing the tissue concentration of pro-inflammatory angiotensin II by decreasing its degradation and reducing the concentration of its physiological antagonist angiotensin 1-7. High levels of angiotensin II on the lung interstitium can promote apoptosis initiating an inflammatory process with release of proinflammatory cytokines, establishing a self-powered cascade, leading eventually to ARDS. It has recently been proposed the tentative use of agents such as losartan and telmisartan as alternative options for treating COVID-19 patients prior to development of ARDS. The present study is an open-label randomized phase II clinical trial for the evaluation of telmisartan in COVID-19 patients. Briefly, patients with confirmed diagnosis of SARS-CoV-2, will be randomized to receive 80 mg/12h of telmisartan plus standard care or standard care alone and will be monitored for development of acute respiratory distress syndrome. Other variables regarding lung function, systemic inflammation and cardiovascular function will also be evaluated.
NCT04355962 Sevoflurane in COVID-19 ARDS (SevCov) Not yet recruiting Phase 2 2020-04-15 The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission in the population of patients suffering from COVID-19 ARDS.
NCT04356690 Etoposide in Patients With COVID-19 Infection Not yet recruiting Phase 2 2020-04-01 This is a single arm, open label study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 as prevention of cytokine storm in patients with COVID-19 infection.
NCT04356833 Nebulised Rt-PA for ARDS Due to COVID-19 Not yet recruiting Phase 2 2020-04-14 Some patients infected with COVID-19 require hospitalisation and develop patients a severe form of a lung disease called respiratory distress syndrome (ARDS). In these patients, the lungs become severely inflamed because of the virus. The inflammation causes fluid from nearby blood vessels to leak into the tiny air sacs in the lungs, making breathing increasingly difficult. This fluid forms small clots in the air sacs, creating a barrier until the cells regenerate. In some patients, this clot does not disappear in a timely fashion or interferes with the development of the new cells. Furthermore, the small clots in the air sacs obstruct the air and oxygen getting deep into the lungs, interfering with proper ventilation. The trial will recruit patients with COVID-19 induced ARDS. Eligible patients (or if patients lack capacity, their legal representative) will be provided with an information sheet and informed consent will be sought. Eligibility will be mainly assessed via routine clinical assessments. Patients will receive a nebulised version of a type of drug called tissue plasminogen activator (rt-PA) that is inhaled using a nebuliser. This is normally a drug used to break down blood clots. In this situation though, it might be useful for stopping clots forming in the lungs, because these might lead to even more difficulties with breathing. The first 12 consented patients will receive nebulised rt-PA in addition to standard of care (SOC). The second group of 12 patients will receive SOC alone as a comparison. To evaluate efficacy, the improvement of oxygen levels over time and safety will be be monitored throughout. Blood samples will be taken to measure markers of clotting and inflammation in both groups. From the end of the treatment phase (after Day 3) both groups will be followed up in accordance with SOC.
NCT04357730 STudy of Alteplase for Respiratory Failure in SARS-Cov2 (COVID-19) Not yet recruiting Phase 2 2020-04-01 The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.
NCT04357782 Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation Recruiting Phase 1/Phase 2 2020-04-16 Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.
NCT04357808 Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID) Recruiting Phase 2 2020-04-13 The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.
NCT04358068 Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 Not yet recruiting Phase 2 2020-05-01 The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19.
NCT04358406 Rhu-pGSN for Severe Covid-19 Pneumonia Not yet recruiting Phase 2 2020-06-01 Study Objectives: Primary - To assess the efficacy (survival without organ failure) of three doses of rhu-pGSN to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia - To evaluate the safety and tolerability of three doses of rhu-pGSN Secondary - To examine individual components of the primary composite endpoint - To assess the relationship of pGSN levels at baseline with clinical outcomes - To assess changes in WHO 9 point severity score Immunogenicity • To investigate the development of antibodies against pGSN post-treatment
NCT04358549 Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19 Recruiting Phase 2 2020-04-17 To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
NCT04358614 Baricitinib Therapy in COVID-19 Completed Phase 2/Phase 3 2020-03-16 Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.
NCT04359095 Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia Not yet recruiting Phase 2/Phase 3 2020-05-11 Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. It is caused by a novel coronavirus with no current specific prevention nor treatment therapies. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab). Clinical trials offer conflicting evidence regarding the effectiveness and safety of therapies The real effectiveness and safety profile of the treatments for COVID-19 remains unknown. Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat adult patients with COVID-19. Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or over with a positive real-time polymerase chain reaction (RT-PCR) for Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality (transaminases greater than 5 reference values), prolonged QT interval, glomerular filtration rate lesser than 30 ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600 participants. The study will be carried out in two phases. The first phase will be conducted with 480 participants and aims to identify treatments with higher or minimum potential, discontinue treatments with higher toxicity and have opportunity of introducing new treatments with potential efficacy. The second phase will be conducted with 1,120 participants to evaluate the effectiveness of the selected treatments. Four interventions have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro and I4 standard treatment. Within each institution, participants will be randomly assigned to one of the treatment arms assigned to that institution. Concealment will be kept through a central telephone. Treatment administration will be open. Variables: Sociodemographic and clinical at recruitment; (comorbidities, need for therapeutic support , grade of invasion at admission). Primary outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement of respiratory support, time to death, number of participants cured, any adverse event related to treatment. Analysis: Descriptive for the presentation of summary measures of the basal conditions by type of variable. Bivariate. Description of the basal conditions (with organic failure at admission, without failure at admission), by type of treatment, by participating institution. Description of crude effectiveness and safety by means of the difference of accumulated incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at 7 and 28 days and severe adverse events between treatments will be estimated, adjusting for confounding variables using logistic regression models with mixed effects considering each institution as a level or from equations. generalized estimation (GEE). Ethical considerations: The study has a risk beyond minimum according to the Resolution 8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed if the patient is in condition to do so. This protocol will undergo evaluation by the ethics committee at each of the participating institutions and at the National University of Colombia. The protocol follows the Helsinki Declaration and institutional protocols for clinical investigation.
NCT04359290 Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS Not yet recruiting Phase 2 2020-05-01 The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.
NCT04359316 Azithromycin in Hospitalized COVID-19 Patients Not yet recruiting Phase 4 2020-04-20 The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04359537 Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 Not yet recruiting Phase 2 2020-04-25 Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.
NCT04359615 Favipiravir in Hospitalized COVID-19 Patients Not yet recruiting Phase 4 2020-04-20 The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04359654 Nebulised Dornase Alfa for Treatment of COVID-19 Not yet recruiting Phase 2 2020-05-01 An open-label, randomised, Best-Available-Care (BAC) and historic-controlled trial of nebulised dornase alfa [2.5 mg BID] for 7 days in participants with COVID-19 who are admitted to hospital and are at risk of ventilatory failure (the COVASE study). Controls will include a randomised arm to receive BAC, historic data from UCLH patients with COVID-19 and biobanked samples will be used to demonstrate an effect of dornase alfa. CRP will be measured to assess the effect of dornase alfa on inflammation. Clinical endpoints and biomarkers (e.g. d-dimer) will be used to assess the clinical response. Exploratory endpoints will explore the effects of dornase alfa on features of neutrophil extracellular traps (NETs).
NCT04359680 Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- or Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers Not yet recruiting Phase 3 2020-04-30 Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- or Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers
NCT04360096 Inhaled Aviptadil for the Treatment of Non-Acute Lung Injury in COVID-19 Not yet recruiting Phase 2/Phase 3 2020-06-01 Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Acute Respiratory Distress Syndrome and the need for mechanical ventilation. Mortality rates as high as 80% have been reported among those who develop ARDS, despite intensive care and mechanical ventilation. Patients with COVID-19 induced non-Acute Lung Injury who have demonstrated reduction in blood oxygenation, dyspnea, and exercise intolerance but do not require endotracheal intubation and mechanical ventilation will be treated with Aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP) plus Standard of Care vs. placebo + Standard of Care. Patients will be randomized to intravenous Aviptadil will receive inhaled Aviptadil, 100 μg 3x daily vs. placebo 3x daily. The primary outcome will be progression to ARDS over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.
NCT04360122 Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19 Not yet recruiting Phase 3 2020-04-20 This randomized open labeled clinical trial will include one hundred healthy healthcare workers who will be randomly assigned into four groups of twenty-five each to receive either levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the incidence of COVID-19 infection. Participants will be followed-up for three months clinically and laboratory. Blood samples will be collected prior to randomization and during follow up.
NCT04360759 Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19 Not yet recruiting Phase 3 2020-05-01 Clinical manifestations of Covid-19 are poorly characterised in HIV co-infection, which may predispose to more severe disease. Reducing hospitalisation and severe illness in this population has important individual and public health benefits. We propose a pragmatic multi-centre, randomized controlled trial in South Africa to evaluate the efficacy and safety of chloroquine or hydroxychloroquine to prevent progression of disease and hospitalisation amongst HIV-positive people with Covid-19 not requiring hospitalisation at initial assessment.
NCT04360824 Covid-19 Associated Coagulopathy Not yet recruiting Phase 4 2020-04-16 This prospective, randomized, open-label, single-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).
NCT04360876 Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial Not yet recruiting Phase 2 2020-05-01 This trial will determine the safety and estimate efficacy of targeted corticosteroids in mechanically ventilated patients with the hyper-inflammatory sub phenotype of ARDS due to coronavirus disease 2019 (COVID-19) by implementing a Phase 2A clinical trial.
NCT04360980 The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection Recruiting Phase 2 2020-03-20 Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
NCT04361214 Leflunomide in Mild COVID-19 Patients Not yet recruiting Phase 1 2020-04-01 This study aims to examine the tolerability of high dose of leflunomide in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.
NCT04361422 Isotretinoin in Treatment of COVID-19 Not yet recruiting Phase 3 2020-04-21 The COVID-19 pandemic caused by SARS-COV-2 has infected over 2,000,000 people causing over 150,000 deaths. A key host cellular protein required for the virus entry is angiotensin-converting enzyme 2 (ACE2) whose expression has been demonstrated in many tissues including alveolar epithelial type II cells in lungs, oral mucosa and intestine, heart, kidney, endothelium and skin. ACE2-expressing cells can act as home cells and are prone to SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry and replication. (1) Fang et al. has suggested that patients with hypertension and diabetes mellitus may be at higher risk of SARS-CoV-2 infection, as these patients are often treated with ACE inhibitors (ACEIs) or angiotensin II type-I receptor blockers (ARBs), which have been previously suggested to increase ACE2 expression. (2) In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are currently being investigated in clinical trials for treating COVID-19 (chloroquine, thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov), none of which was found to significantly alter ACE2 expression (P>0.1) (3) Moreover, Wu et al, demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment by performing target-based virtual ligand screening. (4) In addition, isotretinoin was reported to increase CD4 counts and markedly decrease viremia in HIV positive patients suffering from acne vulgaris. (5) Currently, a study is running to evaluate the effect of isotretinoin on immune activation among HIV-1 infected subjects with incomplete CD4+ T cell recovery. (6) From this point, we can suggest that patient taking isotretinoin therapy may be immune against SARS-COV-2 and it can also have a therapeutic effect by prevention of further progression of the virus. Several potential mechanisms of action of Chloroquine/Hydroxychloroquine against SARS-CoV-2 have been postulated and they are actually used in treatment regimens for COVID-19.(7) It was reported that chloroquine increase the blood level of isotretinoin, so lower doses is required when combined. We assume to test the efficacy of isotretinoin in treatment of COVID-19 versus combined therapy with the standard treatment of COVID-19.
NCT04362085 Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care Not yet recruiting Phase 3 2020-04-01 Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19 coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and an elevated D-dimer (≥2X upper limit of normal {ULN}).
NCT04362111 Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19 Not yet recruiting Phase 3 2020-05-01 This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
NCT04362137 Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID) Not yet recruiting Phase 3 2020-04-30 This is a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 pneumonia.
NCT04362189 Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 Not yet recruiting Phase 2 2020-05-15 Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients hospitalized with COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with or without hydroxychloroquine and azithromycin treatment for patients hospitalized with COVID-19.
NCT04362332 Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19 Recruiting Phase 4 2020-04-14 Rationale: Currently there are no approved treatments for COVID-19. In the Dutch treatment protocol guideline (SWAB) designated treatment is supportive care with the option to add chloroquine base (CQ) or hydroxychloroquine (HCQ). CQ and HCQ are implemented because of their in vitro activity, results from small animal studies, and anecdotal patient's data. There are no published randomized studies with these medications in patients with disease caused by any coronavirus. Objective: To evaluate if treatment with only supportive care or addition of one of two anti-COVID_19 agents (chloroquine or hydroxychloroquine) results in less disease progression in patients with moderate to severe COVID-19 who require hospital admission. Study design: Multicentre, cluster randomized cross-over, open label trial. Hospitals will be randomly allocated to one of 3 treatment arms in sequential periods of one week: chloroquine base versus hydroxychloroquine versus supportive care without any drug presumed active against SARS-COV-2. Patients will be treated based on the date of inclusion. Study population: Adults aged of 18 years and older with moderate to severe, with a NEWS-2 score ≤ 5, laboratory confirmed COVID-19, who require hospital admission in a ward outside the Medium Care or Intensive Care. Intervention (if applicable): Depending on the treatment arm, the study subject will receive only supportive care or an addition with one of the two agents active against SARS-CoV-2 (chloroquine or hydroxychloroquine). Main study parameters/endpoints: Disease progression defined as a NEWS-2 score ≥ 7 within 14 days, or admission to Medium Care or Intensive Care Unit, or death.
NCT04362813 Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia Not yet recruiting Phase 3 2020-04-30 This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in adult patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
NCT04363203 VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL) Not yet recruiting Phase 4 2020-04-01 We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
NCT04363216 Pharmacologic Ascorbic Acid as an Activator of Lymphocyte Signaling for COVID-19 Treatment Not yet recruiting Phase 2 2020-04-01 There are currently no approved therapies for patients with coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Infusion of ascorbic acid (vitamin C) has been shown to increase activity of lymphocytes, which are a crucial component of the body's defense against viral disease progression and adaptive immunity. Ascorbic acid infusion has been shown to be a safe treatment for patients suffering from sepsis and certain types of cancer. This study is designed to evaluate the safety and efficacy of ascorbic acid in the form of sequential I.V. infusions (Ascor®) for patients with suspected COVID-19 who are unlikely to require mechanical ventilation within 24 hours of study intervention.
NCT04363346 Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia Not yet recruiting Phase 1 2020-05-04 This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of safety and efficacy based on stable respiratory function, as well as, determining the feasibility for full-scale studies designed both for efficacy and safety.
NCT04363437 the COMBAT-COVID-19 Pilot Study Recruiting Phase 2 2020-04-23 COVID-19 infection is a respiratory infectious disease caused by a virus called SARS-CoV-2 . This virus is transmitted from person to person through close contacts or respiratory droplets. Symptoms usually start 4 or 5 days after exposure. Some common symptoms include fever, dry cough, feeling tired, muscle aches, and trouble breathing. Although it may affect all organs in our body, it mainly attacks our lungs' ability to help us breathe. There are currently no FDA approved medications to treat COVID-19 infection. Patients are given medications to help alleviate the symptoms. When patients are admitted to the hospital, they are given medications to reduce fever, relieve pain and supplement oxygen. In severe cases, patients are put on a ventilator, a machine designed to to support the lungs. There are a number of drugs undergoing clinical study to see if they are effective in treating the COVID-19 virus. At Maimonides Medical Center, we are taking the appropriate steps to find an effective treatment for COVID-19. The COMBAT COVID-19 Pilot Study is designed for patients diagnosed with COVID-19 infection who require oxygen supplementation to be treated with colchicine to reduce the chance of needing a mechanical ventilator. Colchicine is an FDA approved medication that is used to treat inflammatory disorders such as Gout and Familial Mediterranean Fever. It has also been used to treat other inflammatory conditions such as inflammation around the heart and been demonstrated to help patients who have had an acute heart attack. Colchicine is a readily available drug which is usually well tolerated by patients. We believe that colchicine may reduce the inflammation in the lungs. If so, the lungs may be able heal at a quicker pace and we hope that this may reduce the need for mechanical ventilation. The research will be a randomized trial, patient will be randomly selected to be in either the colchicine treatment group or the standard medicines group. The treatment group will receive colchicine for 14 days or until the day of discharge. The standard medicines group will receive the usual medical therapy as determined by attending physician.
NCT04363450 Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP) Not yet recruiting Phase 3 2020-05-04 This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.
NCT04363502 Use of the Interleukin-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection Not yet recruiting Phase 2 2020-04-01 In this study Investigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1:1 ratio to three study arms that will receive clazakizumab at a dose of 12.5 mg, 25 mg or placebo.
NCT04363827 Protect: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19) Not yet recruiting Phase 2 2020-05-01 This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2). The participants will be randomised to receive either: Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).
NCT04364815 The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial Not yet recruiting Phase 3 2020-04-01 This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut secondary transmission. Hydroxycholoroquine (HCQ) is an inexpensive anti-malarial drug with immunomodulatory effects that are currently used as an off-label treatment for symptomatic COVID-19 patients. In vitro studies have shown that it can efficiently inhibit SARS-CoV-2 infection and has potential as a post-exposure prophylaxis drug.
NCT04365127 Progesterone for the Treatment of COVID-19 in Hospitalized Men Recruiting Phase 1 2020-04-27 The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.
NCT04365153 Canakinumab to Reduce Deterioration of Cardiac and Respiratory Function Due to COVID-19 Recruiting Phase 2 2020-04-24 TThe purpose of this prospective, Phase 2, single center, blinded, randomized controlled study is to demonstrate as a proof of concept that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID-19 infection. These results will lead to and inform a Phase III randomized placebo-controlled trial.
NCT04365309 Protective Effect of Aspirin on COVID-19 Patients Enrolling by invitation Phase 2/Phase 3 2020-02-10 COVID-19 has a high infection rate and mortality, and serious complications such as heart injury cannot be ignored. Cardiac dysfunction occurred in COVID-19 patients, but the law and mechanism of cardiac dysfunction remains unclear. The occurrence of progressive inflammatory factor storm and coagulation dysfunction in severe and fatal cases of NCP points out a new direction for reducing the incidence of severe and critically ill patients, shortening the length of duration in severe and critically ill patients and reducing the incidence of complications of cardiovascular diseases. Aspirin has the triple effects of inhibiting virus replication, anticoagulant and anti-inflammatory, but it has not received attention in the treatment and prevention of NCP. Although Aspirin is not commonly used in the guidelines for the treatment of NCP, it was widely used in the treatment and prevention of a variety of human diseases after its first synthesis in 1898. Subsequently, aspirin has been confirmed to have antiviral effect on multiple levels. Moreover, one study has confirmed that aspirin can inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and upregulation of type I interferon production. Subsequently, pharmacological studies have found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase (COX). Under certain conditions, the platelet is the main contributor of innate immune response, studies have found that in the lung injury model in dynamic neutrophil and platelet aggregation. In summary, the early use of aspirin in covid-19 patients, which has the effects of inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung injury, is expected to reduce the incidence of severe and critical patients, shorten the length of hospital duration and reduce the incidence of cardiovascular complications.
NCT04365517 The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients Not yet recruiting Phase 3 2020-04-30 The COVID-19 pathology is frequently associated with diabetes mellitus and metabolic syndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the Lombardy Region, about two thirds of the patients who died from COVID-19 were affected by diabetes mellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airways that can be fed by a cytokine storm and result in severe respiratory failure (10% cases) and death (5%). The pathophysiological molecular mechanisms are currently not clearly defined. It is hypothesized that the transmembrane glycoprotein type II CD26, known for the enzyme activity Dipeptilpeptidase 4 of the extracellular domain, may play a main role in this condition. It is in fact considerably expressed at the level of parenchyma and pulmonary interstitium and carries out both systemic and paracrine enzymatic activity, modulating the function of various proinflammatory cytokines, growth factors and vasoactive peptides in the deep respiratory tract. Of particular interest is the fact that Dipeptilpeptidase 4 has been identified as a cellular receptor for S glycoprotein of MERS-COV. In the case of the SARS-COV 2 virus, the main receptor is the Angiotensin-Converting Enzyme 2 protein, but a possible interaction with Dipeptilpeptidase 4 also cannot be excluded. The selective blockade of Dipeptilpeptidase 4 could therefore favorably modulate the pulmonary inflammatory response in the subject affected by COVID-19. This protein is also known for the enzymatic degradation function of the native glucagon-like peptide 1, one of the main regulators of insulin secretion. This is why it is a molecular target in the treatment of diabetes (drugs that selectively inhibit Dipeptilpeptidase 4 are marketed with an indication for the treatment of type 2 diabetes). It is believed that the use of a Dipeptilpeptidase 4 inhibitor in people with diabetes and hospitalized for Covid-19 may be safe and of particular interest for an evaluation of the effects on laboratory and instrumental indicators of inflammatory lung disease. Among the drugs that selectively block Dipeptilpeptidase 4, the one with the greatest affinity is Sitagliptin.
NCT04365582 OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome Not yet recruiting Phase 3 2020-04-28 COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.
NCT04365699 Cardiovascular Effects of COVID-19 Recruiting Phase 2 2020-04-08 This is a prospective single-center registry with an embedded open-label single-arm clinical trial to determine the effects of standard of care treatment vs. standard of care plus AT-001 on cardiac structure and function and in-hospital survival in patients hospitalized for management of COVID-19 infection. Eligible subjects with COVID-19 infection will be identified at the time of hospital admission based on existing infection control surveillance protocols, and will have clinical data extracted from the electronic medical record to determine clinical characteristics associated with cardiac structure and function and in-hospital survival. A subset of patients with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >126 mg/dl) and evidence of acute or chronic heart disease will be treated in an open-label fashion to receive an investigational aldose reductase inhibitor, AT-001 plus standard of care.
NCT04365985 Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19 Not yet recruiting Phase 2 2020-04-01 Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.
NCT04366089 Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora Recruiting Phase 2 2020-03-26 Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.
NCT04366115 Evaluating AVM0703 for Treatment of COVID-19 Not yet recruiting Phase 1/Phase 2 2020-06-01 This is a randomized, double-blind, placebo-controlled, single-ascending dose study of AVM0703 administered as a single intravenous (IV) infusion to patients with COVID-19. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single-ascending dosing of AVM0703 in patients with COVID-19.
NCT04366739 Repurposing of Chlorpromazine in Covid-19 Treatment Not yet recruiting Phase 3 2020-04-29 This study evaluates the effects of the addition of chlorpromazine to the standard therapeutic protocol in COVID-19 patients hospitalized for respiratory symptom management (score 3-5 WHO Ordinal Scale for Clinical Improvement).
NCT04366960 Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients Not yet recruiting Phase 3 2020-05-01 The purpose of this study is to determine whether a higher dose of low molecular weight heparin (enoxaparin 40 mg b.i.d.) is superior than the standard prophylaxis dose (enoxaparin 40 mg o.d.) in reducing thromboembolic events in COVID-19 patients.
NCT04367831 Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19 Not yet recruiting Phase 4 2020-05-01 This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
NCT04368377 Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19 Completed Phase 2 2020-04-06 This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).
NCT04370262 Multi-site Adaptive Trials Using Hydroxycholoroquine for COVID-19 Recruiting Phase 3 2020-04-07 The overall objective of the study will be to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC) combined with pharmaceutical antiviral management using hydroxychloroquine, or SOC with hydroxychloroquine combined with high-dose intravenous famotidine, in hospitalized patients meeting nucleic acid diagnostic and radiologic criteria for COVID-19 disease. The trial will statistically compare the clinical benefit afforded by the two treatment strategies to internal historical "standard of care" data from Northwell patents treated without benefit of either hydroxychloroquine or high-dose famotidine. We will compare clinical outcomes associated with hydroxychloroquine and the addition of high-dose intravascular famotidine. The trial is designed to enroll at least 600 COVID-19 patients hospitalized with moderate to severe disease into each of the two active treatment arms, with a total enrollment target of at least 1200 patients. The proposed trial has been designed for rapid enrollment and completion and powered to support two interim analyses that will enable prompt assessment of benefits and risks of the two treatment groups while maintaining the rigorous gold standard of a randomized double blind clinical trial structure. Trial design has been guided by practical consideration of the current clinical context involving rapidly escalating demands on hospital staff and resources, and incorporates a minimalist approach employing existing laboratory information management systems and a clinically relevant binary primary outcome of 30-day endpoint of death or survival.
NCT04370782 Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting Not yet recruiting Phase 4 2020-04-28 This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.
NCT04371393 MSCs in COVID-19 ARDS Not yet recruiting Phase 3 2020-04-01 The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L® plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
NCT04371406 Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients Not yet recruiting Phase 3 2020-05-02 Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients. It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.
NCT04371822 Efficacy of Sn-protoporphyrin IX (SnPPIX) and Sulfonated Tetranaphthyl Porphyrin Against Covid-19 Not yet recruiting Phase 1 2020-05-01 Efficacy of Sn-protoporphyrin IX (SnPPIX) and sulfonated tetranaphthyl porphyrin Against Covid-19 Mahmoud ELkazzaz(1) 1-Principal Investigator Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt Mail:mahmoudramadan2051@yahoo.com Tel:00201090302015 _____________________________________________________________________________________________ _________________________________________________________________________ Abstract : The novel coronavirus pneumonia (COVID-19) is an infectious acute respiratory caused by the novel coronavirus. The virus is a positive-strand RNA virus with high homology to bat coronavirus. Depending on published study in which , conserved domain analysis, homology modeling, and molecular docking were used to compare the biological roles of specific proteins of the novel coronavirus. The principal investigator demonstrated according to previous researches that some viral structural and nonstructural proteins could bind to the porphyrin, respectively. At the same time, orf1ab, ORF10 and ORF3a proteins coordinated to attack heme on the 1-beta chain of hemoglobin, COVID-19 binds to the porphyrin of haem and displaces iron and a study denonestrated that Covid-19 could cause acquired acute porphyria which is the condition in which there is excess accumulation of porphyrin intermediate metabolites. This point can be taken advantage of X-ray induced visible luminescence of porphyrin for producing of Reactive Oxygen Species (ROS). Porphyrins have been used for photodynamic therapy (PDT) against a wide range of targets like bacteria, viruses and tumor cells It has been reported that ROS-based inactivation of viruses may occur due to several reasons, such as protein oxidation, single strand breaks in the RNA genome and protein-RNA crosslinking. Since ROS-based inactivation has a multi-targeted mechanism, it is much less likely that a virus would be able to develop resistance against it. Recently, porphyrins, already in use as photosensitizers for Photodynamic Therapy (PDT), were a study target to applications in medical area, namely as possible contrast agents in MRI. could be observed some examples of porphyrin derivatives already study as MRI contrast media. Low dark toxicity, neoplastic tissue affinity and synthetic accessibility are some of the important properties that contribute for its selection. In MRI studies was found that CM based on paramagnetic metalloporphyrins showed higher affinity for neoplastic tissues, observed by increased relaxation time of the neoplastic tissues, which is reflected on an increase in MRI signal and consequently in a better neoplastic lesions detection. Therefore, the principal investigator expects that treatment with x-ray induced visible luminescence of porphyrins will be effective in targeting of COVID-19. Keywords: COVID 2019 ,Infection, Sulfonated porphyrins and X-ray induced visible luminescence of porphyrin
NCT04371926 Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk Not yet recruiting N/A 2020-06-01 Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.
NCT04372589 Antithrombotic Therapy to Ameliorate Complications of COVID-19 ( ATTACC ) Not yet recruiting N/A 2020-05-01 The purpose of the study is to evaluate the efficacy of therapeutic-dose parenteral heparin versus usual care in hospitalized COVID-19 patients (e.g. reduced intubation, mortality).
NCT04372628 Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19 Not yet recruiting Phase 2 2020-05-01 Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine vs lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19
NCT04373044 Antiviral Therapy and Baricitinib for the Treatment of Patients With Moderate or Severe COVID-19 Not yet recruiting Phase 2 2020-04-24 This phase II trial studies how well antiviral therapy works when given in combination with baricitinib for the treatment of moderate or severe coronavirus disease-2019 (COVID-19). Antiviral therapy such as hydroxychloroquine, lopinavir/ritonavir, and remdesivir may act against infections caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation and help prevent the need for being placed on a ventilator should the disease worsen. Giving antiviral therapy in combination with baricitinib may reduce the risk of the disease from getting worse compared to antiviral therapy alone.
NCT04373733 A Randomised Controlled Trial of Early Intervention in COVID-19: Favipiravir Verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe Not yet recruiting Phase 3 2020-05-01 Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either a combination of azithromycin, hydroxychloroquine and zinc or favipiravir, alongside usual care, can help patients with suspected or proven COVID-19 infection.
NCT04374149 Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS Not yet recruiting Phase 2 2020-04-30 This protocol will evaluate the efficacy of Therapeutic Plasma Exchange alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome. It is hypothesized that dual intervention of acute apheretic depletion of cytokines and concomitant suppression of production will produce superior amelioration of the cytokine load and to help to prevent cytokine load rebound. This protocol is envisioned as a pilot study (n=20) for hypothesis generation for future investigation.
NCT04374487 A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications Not yet recruiting Phase 2 2020-05-09 The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.
NCT04374552 Asymptomatic COVID-19 Trial Not yet recruiting Phase 2 2020-05-05 The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While there are no known therapies to treat those who have become sick, there have been some reports that a medication currently used to treat rheumatoid arthritis, lupus, and malaria (Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or severity of illness, especially if combined with a medicine that treats other kinds of infections (Azithromycin, also known as Zithromax or Zmax or Zpak). There are some people who test positive for the virus but who are otherwise not ill. Current standard of care is to advise these people to self-monitor but no treatment is offered. It is not known how many of these individuals will remain symptom free, and how many will become sick or how severe those symptoms will be. This study will randomize those people who do not have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2) no active medication (placebo). All participants will be followed for 2 months. The study will determine if there is any benefit to those who are asymptomatic to taking taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit from taking these medications.
NCT04374565 Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia Not yet recruiting Phase 2 2020-05-05 This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.
NCT04375046 Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 Not yet recruiting Phase 1 2020-08-01 Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug better than recombinant human ACE2 Mahmoud ELkazzaz1 1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt. _____________________________________________________________________________________________ _______________________________________________________________________ B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular physiology and pathology, and is currently clinically evaluated to treat acute lung failure. Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis, B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. In vitro, recombinant B38-CAP protein catalyzed the conversion of angiotensin II to angiotensin 1-7, as well as other known ACE2 target peptides. Treatment with B38-CAP suppressed angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis in mice. Moreover, B38-CAP inhibited pressure overload-induced pathological hypertrophy, myocardial fibrosis, and cardiac dysfunction in mice. Our data identify the bacterial B38-CAP as an ACE2-like carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein drugs for hypertension and heart failure.On the contraryTreatment with recombinant human ACE2 protein (rhACE2), which is devoid of its membrane-anchored domain thus soluble, has been demonstrated to exhibit beneficial effects in various animal models including heart failure, acute lung injury, and diabetic nephropathy, and so forth. rhACE2 is currently tested in the clinic to treat ARDS and COVID-19 infected patients . Using cell cultures and organoids, researchers from the Karolinska Institutet in Sweden and the University of British Columbia (UBC) in Canada, showed that by adding a genetically modified variant of ACE2, called human recombinant soluble angiotensin-converting enzyme 2 (hrsACE2), COVID-19 was prevented from entering cells.The paper, published in Cell, shows that hrsACE2 had a dose dependent effect of viral growth of SARS-CoV-2 and was able to reduce it by a factor of 1,000 to 5,000 in cell cultures. Despite its beneficial effects, rhACE2 is a glycosylated protein and thus its preparation requires time- and cost-consuming protein expression system with mammalian or insect cells, which may not be advantageous in drug development and medical economy Although it had been reported that an immune response is associated with the chronic infusion of rhACE2 resulting in the degradation of rhACE226, this was not observed for B38-CAP; there were no antibodies against B38-CAP detectable in the serum of mice infused with B38-CAP for 2 weeks. Implantation of B38-CAP-filled osmotic mini-pumps significantly suppressed Ang II-induced hypertension in conscious mice .without affecting the heart rate. These results indicate that B38-CAP antagonizes the vasopressor effect of Ang II. So the principle investigator expects and suggests that treating with cloned Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug better than recombinant human ACE2 in addition to brsACE2, expected to lure the virus to attach itself to the copy instead of the actual cells… It distracts the virus from infecting the cells to the same degree and should lead to a reduction in the growth of the virus in the lungs and other organs. A study showed that recombinant B38-CAP protein downregulates Ang II levels in mice and antagonizes Ang II-induced hypertension, pathological cardiac hypertrophy, and myocardial fibrosis. We also show beneficial effects of B38-CAP on the pathology of pressure overload-induced heart failure in mice without overt toxicities. Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226. _____________________________________________________________________________________________ ________________________________________________________________________ This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rbACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.
NCT04375202 Colchicine in COVID-19: a Pilot Study Recruiting Phase 2 2020-04-18 This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
NCT04376788 Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19 Not yet recruiting Phase 2 2020-05-05 The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.
NCT04377503 Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19 Not yet recruiting Phase 2 2020-05-01 This study compare the efficacy and safety of tocilizumab versus methylprednisolone in the cytokine release syndrome of patients with COVID-19
NCT04377997 Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19 Not yet recruiting Phase 2 2020-05-15 The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity and mortality in over 170 countries. Increasing age and burden of cardiovascular comorbidities are associated with a worse prognosis among patients with COVID-19. In addition, serologic markers of more severe disease including coagulation abnormalities and thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19 infection and are more common in patients who died in-hospital. As the COVID-19 pandemic continues to grow, there is a pressing need to identify safe, effective, and widely available therapies that can be scaled and rapidly incorporated into clinical practice. Understanding the putative mechanism of increased mortality risk associated with abnormal coagulation function and cardiac injury is critical to guide studies of promising therapeutic interventions. Published and anecdotal reports indicate that endothelial dysfunction and thrombosis are common in critically ill patients with COVID-19, including reports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys. Patients with cardiovascular disease (CVD) and CVD risk factors are known to have endothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19 inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mL was associated with an 18 times higher risk of in-hospital death, underscoring the importance of increased coagulation activity as a potential modifiable risk marker that may drive end-organ injury. Given the established link between endothelial dysfunction and thrombosis in patients with cardiovascular disease, and the association between coagulopathy and adverse outcomes in patients with sepsis, the association between increased coagulation activity, end-organ injury, and mortality risk may represent a modifiable risk factor among COVID-19 patients with critical illness. Therefore, we propose to conduct a randomized, open-label trial of therapeutic anticoagulation in COVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.
NCT04378244 CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 Not yet recruiting Phase 1/Phase 2 2020-06-12 COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2. COVID-19 causes life threatening complications known as Cytokine Release Syndrome or Cytokine Storm and Acute Respiratory Distress Syndrome. These complications are the main causes of death in this global pandemic. Over 1000 clinical trials are on-going worldwide to diagnose, treat, and improve the aggressive clinical course of COVID-19. The investigators propose the first, and so far, only gene therapy solution that has the potential to address this urgent unmet medical need. Rationale 1. DeltaRex-G is a safe, non-pathogenic, replication incompetent, RNA virus-based gene vector. DeltaRex-G nanoparticles (~100 nm) can mimic RNA virus SARS-CoV-2 by binding to viral receptors in human cells and may serve as a decoy to prevent SARSCoV-2 cell entry by crowding/neutralizing the SARS-CoV-2 even where the receptors may be different. 2. DeltaRex-G is a disease-seeking retrovector encoding a cytocidal dominant negative human cyclin G1 as genetic payload). When injected intravenously, the DeltaRex-G nanoparticles has a navigational system that targets exposed collagenous proteins (XC proteins) in injured tissues (e.g. inflamed lung, kidney, etc.), thus increasing the effective drug concentration at the sites of injury, in the vicinity of activated/proliferative T cells evoked by COVID-19. The DeltaRex-G then enters the rapidly dividing T cells and kills them by arresting the G1cell division cycle, hence, reducing cytokine release and ARDS; 3. Intravenous DeltaRex-G has minimal systemic toxicity due to its navigational system (targeting properties) that limits the biodistribution of DeltaRex-G only to areas of injury where exposed collagenous (XC) proteins are abnormally found; and 4. DeltaRex-G is currently available in FDA approved "Right to Try" or Expanded Access Program for Stage 4 cancers for an intermediate size population. To gain this approval, FDA requires DeltaRex-G to have demonstrated safety and efficacy in early clinical trials.
NCT04379271 A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19) Not yet recruiting Phase 2/Phase 3 2020-05-01 At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor's choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood. Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies.
NCT04379479 Clinical Effect of Dialyzable Leukocyte Extract in Suspected or Confirmed Cases of COVID-19 (FUTURE-T) Not yet recruiting Phase 2 2020-05-01 Main goal: To generate information on the efficacy and safety of Dialyzable Leukocyte Extract (DLE) as an aid in the treatment of patients with acute respiratory infection (suspected or confirmed cases of COVID-19). Primary goal: To generate information on the efficacy of DLE as an aid in symptomatic treatment, by reducing the signs and symptoms of acute respiratory infection (suspected/confirmed cases of COVID-19). Secondary goals: 1. To evaluate clinical deterioration and respiratory alarm data. 2. To evaluate the duration of the clinical picture. 3. To explore cytokine changes associated with the therapeutic effect induced by DLE. 4. To obtain data on the safety of DLE as an aid in the symptomatic treatment of acute respiratory infection (suspected/confirmed cases of COVID-19). 5. To generate information to validate the contingency scale to assess the severity of acute respiratory disease (suspected/confirmed cases of COVID-19). Justification The systemic inflammatory response has been recognized as being responsible for COVID-19 complications. Immunomodulation strategies to control it are currently being considered, including the use of systemic steroids to down-regulate the systemic inflammatory response, the use of human immunoglobulin and even chloroquine given its anti-inflammatory and antiviral qualities; however, none of these treatments has been sufficiently studied or has shown any significant change in the clinical course of infected patients. Due to the importance of the COVID-19 pandemic and in the absence of specific treatment, it is important to implement new treatments that allow modulating the immune response, and one strategy may be the addition of DLE to symptomatic and supportive treatment. Hypotheses by goals. 1. The addition of DLE to the symptomatic treatment could decrease the severity of the clinical outcome (signs and symptoms) in individuals with an acute respiratory infection (cases suspected/confirmed by COVID-19). 2. The addition of DLE to the symptomatic treatment could decrease the clinical deterioration due to the acute respiratory infectious process (suspected/confirmed cases of COVID-19). 3. The addition of DLE to the symptomatic treatment could decrease the duration of the clinical outcome (suspected/confirmed cases of COVID-19).
NCT04379518 Rintatolimod and IFN Alpha-2b for the Treatment of Mild or Moderate COVID-19 Infection in Cancer Patients Not yet recruiting Phase 1/Phase 2 2020-05-30 This phase I/IIa trial studies the side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
NCT04380376 Low-doses Melphalan Inhalation in Patients With COVID-19 (CoronavIrus Disease 2019) Pneumonia Recruiting Phase 2 2020-04-30 This single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.
NCT04380402 Atorvastatin in COVID-19 Not yet recruiting Phase 2 2020-05-08 Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.
NCT04380519 Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19) Recruiting Phase 2/Phase 3 2020-04-23 The primary objective of the study is to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study
NCT04381052 Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection Not yet recruiting Phase 2 2020-05-01 In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.
NCT04381377 Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19 Recruiting Phase 2/Phase 3 2020-04-29 The purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.
NCT04381858 Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia Recruiting Phase 3 2020-05-06 Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives. Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection. Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin. Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.
NCT04381884 Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19 Not yet recruiting Phase 2 2020-05-07 In the context of COVID-19 pandemic, a report on ivermectin suppression of SARS-CoV-2 viral replication in cell cultures has been published, and the use of this medication seems to be potentially useful for the therapy. IVM safety profile and IVM wide spectrum enables to move forward with the investigation in patients infected by SARS-CoV-2 as a proof-of-concept of its possible use in the management of patients with COVID-19, given the current pandemic situation.
NCT04381936 Randomized Evaluation of COVID-19 Therapy Recruiting Phase 2/Phase 3 2020-03-19 RECOVERY is a randomised trial investigating whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin or Tocilizumab prevents death in patients with COVID-19.
NCT04381962 A Multi-centre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID-19 (ATOMIC2) Not yet recruiting Phase 3 2020-05-13 A multi-centre open-label two-arm randomised superiority clinical trial of two weeks of oral Azithromycin 500mg once daily versus usual care in adult patients presenting to secondary care with clinically-diagnosed COVID-19 but assessed as appropriate for initial ambulant (outpatient) management, in preventing progression to respiratory failure or death.
NCT04382040 A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 Recruiting Phase 2 2020-05-08 Agent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2. Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events. Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy. Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2. Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities. Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19. Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19. Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.
NCT04382053 Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia Not yet recruiting Phase 2 2020-05-15 The study will assess the efficacy and safety of DFV890 for the treatment of SARS-Cov-2 infected patients with COVID-19 pneumonia and impaired respiratory function.
NCT04382066 Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19 Recruiting Phase 1 2020-05-07 In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as a potential antiviral agent, based on pre-clinical studies, this randomized, parallel and proof of concept trial will evaluate the safety of three doses of plitidepsin in patients hospitalized with COVID-19.
NCT04382651 Study of Efficacy and Safety of MAS825 in Patients With COVID-19 Not yet recruiting Phase 2 2020-05-15 The study will assess the efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function
NCT04382924 Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients Not yet recruiting Phase 2/Phase 3 2020-07-01 The purpose of this adaptive trial is to determine the clinical efficacy of Ifenprodil in the treatment of patients infected with COVID-19. This Protocol is largely based on the recommendations of the WHO R&D Blueprint Clinical Trials Expert Group COVID-19 Therapeutic Trial Synopsis, and associated Master Protocol. The choice of the primary outcome measure will be determined by a pilot study of the first 100 subjects. Subject clinical status (on a 7-point ordinal scale) at day 15 in treatment versus the control group is the default primary endpoint.
NCT04384380 Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19 Recruiting Phase 4 2020-04-01 The effective medical treatment against COVID-19 infection is still unknown. Chloroquine phosphate is a well-known antimalarial drug which has been on the market for many years. Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also an immune-modifier and could distribute to the whole body including lung. Also, chloroquine is cheap and safe, and could be a promising agent against COVID-19 infection. However, only hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore, hydroxychloroquine instead become the best choice for the treatment candidate, since it shows higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the original effect which compared with chloroquine.
NCT04384458 COVID-19 Prophylaxis With Hydroxychloroquine Associated With Zinc For High-Risk Healthcare Workers Not yet recruiting N/A 2020-05-01 We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc effective as a prophylaxis for asymptomatic healthcare workers involved in the treatment of suspected or confirmed cases of COVID-19?
NCT04385043 Hyperimmune Plasma in Patients With COVID-19 Severe Infection Recruiting Phase 2/Phase 3 2020-05-01 Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma - or "hyperimmune" plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, hyperimmune plasma appears to be one of the most rational and promising. The objective of this study will be to evaluate the efficacy and safety of the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to clinical practice in patients with severe Covid-19 infection, compared to patients with severe Covid-19 infection treated only with standard therapy.
NCT04386239 Study on the Use of Sarilumab in Patients With COVID-19 Infection Not yet recruiting Early Phase 1 2020-05-01 Sarilumab is an anti-interleukin-6 human monoclonal antibody, such as tocilizumab, which is administered subcutaneously every two weeks for the treatment of moderate to severe active rheumatoid arthritis in adult patients. Despite the effectiveness reported for tocilizumab in the recently published experiences, the need to rapidly find alternative therapies to manage the complications of Covid-19 infection remains extremely high. The lack of clinical experience on the usage of sarilumab in such patients prevents the possibility of adopting early access programs for using commercially available sarilumab (prefilled syringe) packs in patients with severe Covid-19 pneumonia. The present study is aimed to generate a rapid, still robustly documented, evidence on the potential clinical efficacy and tolerability of a further IL-6R antagonist in Covid-19 pneumonia.
NCT04386447 Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19 Not yet recruiting Phase 2 2020-06-03 Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis
NCT04386850 Oral 25-hydroxyvitamin D3 and COVID-19 Recruiting Phase 2/Phase 3 2020-04-14 The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 [25(OH)D3] for reducing the risk of acquiring the SARS-CoV-2 (COVID-19) viral infection and mitigating morbidity and mortality associated with this infection. This evidence-based hypothesis is related to several observations. Macrophages, activated T and B lymphocytes have a vitamin D receptor and 1,25-dihydroxyvitamin D3 induces defensin protein synthesis, influences immunoglobulin production and modulates T-cell cytokine production and functions. 1,25-dihydroxyvitamin D3 also reduces the angiotensin-converting enzyme 2 (ACE2) that is believed to serve as the binding site and gateway for COVID-19 to become infectious. This is a multicenter randomized3 doubleblinded placebo-controlled study aimed at determining the benefits of 25(OH)D3 treatment for the prevention of COVID-19 infection and improving clinical outcomes in infected patients. We plan to recruit 1500 subjects in 3 study groups that include hospital health providers, patients with a positive test for COVID-19 and their relatives with a negative test. Eligible subjects in each study group with a documented serum level of 25(OH)D < 20 ng/mL will be randomized. Recruited subjects will be given 25 mcg of 25(OH)D3 daily or an identically appearing placebo at the time of randomization for two months. Three hospitals will participate and the sample size is foreseen to be equally distributed between the three. Since the clinical trial is designed as minimal risk a formal committee for data monitoring is not foreseen. However, potential toxicity will be monitored every 4 weeks with a serum calcium, albumin and creatinine by the PI and the study coordinators. If the corrected serum calcium increases above 10.6 mg/dl and a repeat confirms that the calcium is above 10.6 mg/dL the subject will be dropped from the study and referred to his or her PCP. Early signs and symptoms of vitamin D toxicity associated with hypercalcemia are increased thirst, increase in frequency of urination, especially at night. The subjects will be followed up weekly by phone to ask about their sign and symptoms.
NCT04387240 Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19 Not yet recruiting Phase 2 2020-06-01 Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections. In this Clinical trial, we will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. We are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,
NCT04387760 Favipiravir vs Hydroxychloroquine in COVID -19 Not yet recruiting Phase 2/Phase 3 2020-05-14 Hydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has found that a high concentration of cytokines were detected in the plasma of critically ill patients infected with SARS-CoV-2, therefore, hydroxychloroquine as anti-inflammatory agents may reduce this response in accord with their use in autoimmune disease where the cytokine response can be reduced. Favipiravir is an antiviral drug developed in Japan that the data sheet notes that it is a pyrazinecarboxamide derivative with activity against influenza viruses, west nile virus, yellow fever virus, foot and mouth disease virus as well as against flaviviruses, arenaviruses, bunyaviruses and alphaviruses. In February the drug was used for COVID-19 disease in China and was declared effective in treatment, and a report published (in press) comparing Favipiravir with Lopinavir /ritonavir suggested that Favipiravir was superior for prevention of disease progression and viral clearance. The objective of this pilot study is to compare 3 arms: hydroxychloroquine; favipiravir; supportive treatment only, in symptomatic patients infected by SARS-CoV-2 in an open label randomized clinical trial. The difference between groups will allow an effect size to be determined for a definitive clinical trial
NCT04388683 The NO-COVID Study Recruiting Phase 2 2020-05-12 This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age > 60 years, type II DM, hypertension, and obesity.
NCT04389359 PROphylaxis for paTiEnts at Risk of COVID-19 infecTion Not yet recruiting Phase 2/Phase 3 2020-05-01 The PROTECT open-label randomised basket trial will assess the effectiveness of hydroxychloroquine (HCQ) as chemoprophylaxis against COVID-19 in multiple vulnerable populations in the United Kingdom.
NCT04389411 The COvid-19 Symptom MOntelukast Trial Not yet recruiting Phase 2/Phase 3 2020-07-01 Due to the rapidly developing nature and severity of the COVID-19 pandemic, clinical trials involving a repurposed drug approach are the best option for rapidly identifying an effective COVID-19 therapeutic. We propose to evaluate the efficacy of Montelukast in attenuating cytokine storm syndrome and ARDS via a randomized, blinded, placebo-controlled clinical trial. Specifically, our primary objective is comparing the efficacy of low-dose Montelukast versus placebo in reducing the risk of acute care visits and hospital admissions among COVID-19 positive patients in the general population.
NCT04389671 The Safety and Preliminary Efficacy of Lucinactant in Adults With COVID-19 Not yet recruiting Phase 1/Phase 2 2020-06-01 This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.
NCT04389710 Convalescent Plasma for the Treatment of COVID-19 Recruiting Phase 2 2020-04-15 This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
NCT04389840 Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure Not yet recruiting Phase 2/Phase 3 2020-05-01 A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.
NCT04390152 Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19 Not yet recruiting Phase 1/Phase 2 2020-06-01 Recent COVID 19 pandemic has overwhelmed health services all around the world, and humanity has yet to find a cure or a vaccine for the treatment of patients, mainly the severe ones, who pose a therapeutic challenge to healthcare professionals given the paucity of information we have regarding SARS-CoV-2 pathogenesis. Recently, reports mainly from China from patients treated with mesenchymal stem cells have shown promise in accelerating recovery, even in the critically ill and the therapy has sustained an increase in research because of it's powerful immunomodulatory effects, making it and interesting alternative in patients with lung and systemic inflammation. These effects could help treat a lot of patients and improve their outcomes, reason why phase I/II studies are needed to show their safety and experimental efficacy.
NCT04390217 LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia Not yet recruiting Phase 2 2020-06-30 This is a Phase 2, proof of concept, randomized, placebo-controlled, multicenter study to evaluate the ability of LB1148 to attenuate pulmonary dysfunction associated with COVID-19 pneumonia. The primary objective of this study is to determine if enteral administration of LB1148 will effect disease progression in hospitalized patients with moderate to severe COVID-19 via measurement of the proportion of subjects alive and free of respiratory failure at Day 28.
NCT04390464 mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R) Recruiting Phase 4 2020-05-08 TACTIC-R is a randomised, parallel arm, open-label platform trial for investigating potential treatment for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage. Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. Therefore, this study proposes to assess the efficacy of immunomodulatory agents that target dysregulated immune response that drive the severe lung, and other organ, damage. The medications investigated for efficacy in this trial are Baricitinib and Ravulizumab. Reference: Gralinski and Baric 2015. Molecular pathology of emerging coronavirus infections. J Pathol 2015: 235: 185-195; DOI: 10.1002/path.4454
NCT04390594 Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal Not yet recruiting Phase 3 2020-06-01 COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020. In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among adults, of different therapeutic regimens considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP). Two therapeutic regimens have been eligible in the short term for SEN-CoV-Fadj: Hydroxychloroquine (HCQ) on one hand, and the combination of Hydroxychloroquine and Azithromycin (HCQ + AZM) on the other hand.
NCT04391101 Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19) Not yet recruiting Phase 3 2020-06-01 Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU
NCT04391127 Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection Recruiting Phase 3 2020-05-04 Background: In December 2019, patients with pneumonia secondary to a new subtype of Coronavirus (COVID-19) were identified in China. In a few weeks the virus spread and cases started practically all over the world. In February 2020, the WHO declared a pandemic. Severe symptoms have been found in patients mainly with comorbidities and over 50 years of age. At this time there is no proven therapeutic alternative. In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results. So far there is no standard of treatment and clinical trials are needed to find effective treatment alternatives. Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients. Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule. Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day. Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed. If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned. Outcomes: The primary outcome will be discharge from hospital for improvement. The safety outcomes will be requirement of mechanical intubation, septic shock or death. Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.
NCT04392128 Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies Not yet recruiting Phase 2 2020-05-12 The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
NCT04392427 New Antiviral Drugs for Treatment of COVID-19 Not yet recruiting Phase 3 2020-05-01 Background: In December 2019, SARS-CoV-2 was isolated on Vero E6 and Huh7 cell lines after an outbreak of pneumonia of unknown origin in Wuhan, Hubei Province, China. Since the basis for pathogenesis of this virus and its proliferation is unclear, there is still no definitive treatment or vaccine against it. Thus, medications used against SARS-CoV-2 are mainly based on their effectiveness on in vitro studies, virtual screenings and records of their effects on earlier strains of coronavirus, SARS and MERS. Therefore, the immediate introduction of potential COVID-19 treatments can be essential and salvaging. Aim: to compare the rate and time of viral clearance in subjects receiving the combination of Nitazoxanide, Ribavirin and Ivermectin vs. those control group (without any intervention). Methods: a sequential clinical trial in this design sample size is not fixed in advance. Instead data will be evaluated as they are collected, and further sampling is will be stopped in accordance with a pre-defined stopping rule as soon as significant results are observed. After "n" (10 subjects in each group) subjects in each group are available an interim analysis will be conducted. A statistical test will be performed to compare the two groups and if the null hypothesis is rejected the trial is terminated; otherwise, the trial continues, another n subjects per group will be recruited, and the statistical test is performed again, including all subjects. If the null is rejected, the trial is terminated, and otherwise it continues with periodic evaluations until a maximum number of interim analyses have been performed, at which point the last statistical test is conducted and the trial is discontinued [25]. Outcome: The combination of Nitazoxanide, Ribavirin, Ivermectin and Zinc could be effective in clearance of COVID 19. KEY WOARD: COVID-19; clinical trial; corona virus
NCT04392713 Efficacy of Ivermectin in COVID-19 Recruiting N/A 2020-04-15 It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.
NCT04393051 Baricitinib Compared to Standard Therapy in Patients With COVID-19 Not yet recruiting Phase 2 2020-05-20 There is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for 2019-nCoV acute respiratory disease, because of its immunomodulant and hypothesized antiviral activity. This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive or not baricitinib as adjunctive therapy. All patients will continue to receive the already administered standard therapy: chloroquine/idrossichloroquine and low-molecular weight eparin (LMWH) eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all included patients. The primary endpoint measure is the efficacy of baricitinib in reducing the number of patients requiring invasive ventilation after 7 and 14 days of treatment. Secondary enpoints will be mortality rates and toxicity of baricitinib.
NCT04393246 mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E) Not yet recruiting Phase 2/Phase 3 2020-05-20 TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID-19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage. Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. This study will assess the efficacy of a novel immunomodulatory agent and a novel combination of approved agents which may protect the patient against end-organ damage and modulate the pulmonary vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel combination of the approved agents dapagliflozin and ambrisentan against Standard of Care. Reference: Gralinski and Baric 2015. Molecular pathology of emerging coronavirus infections. J Pathol 2015: 235: 185-195; DOI: 10.1002/path.4454
NCT04393792 SINUS WASH Pilot Study in Adults Testing Positive for COVID-19 Recruiting Phase 1 2020-05-01 COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.
NCT04394208 Silymarin in COVID-19 Pneumonia Not yet recruiting Phase 3 2020-06-01 A randomized placebo controlled trial to assess the clinical outcome in COVID-19 Pneumonia following administration of Silymarin owing to its role as a p38 MAPK pathway inhibitor and its antiviral, anti-inflammatory and anti-oxidant effects
NCT04394377 Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial Not yet recruiting Phase 4 2020-05-01 Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer. Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation
NCT04394416 Trial of Imatinib for Hospitalized Adults With COVID-19 Not yet recruiting Phase 3 2020-05-20 This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19
NCT04395170 Convalescent Plasma Compared to Anti-COVID-19 Human Immunoglobulin and Standard Treatment (TE) in Hospitalized Patients Not yet recruiting Phase 2/Phase 3 2020-06-01 A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.
NCT04395768 International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Not yet recruiting Phase 2 2020-05-25 COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some of these, plus some with Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients.
NCT04397328 COVID-19 PEP- High-risk Individuals in Long-term and Specialized Care - Canada Not yet recruiting Phase 3 2020-05-19 Older adults are at the highest risk of complications and severe illness for 2019-nCoV infections. Hydroxychloroquine (HCQ), an emerging chemoprophylaxis, which holds clinical and mechanistic plausibility, will help to reduce disease incidence and mitigate disease severity across in-patient settings. This study is designed to assess the safety and efficacy of post-exposure prophylaxis with hydroxychloroquine (HCQ) for the prevention of Coronavirus Infectious Disease-19 (COVID-19) in high-risk older individuals in long-term and specialized care.
NCT04397497 Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19) Not yet recruiting Phase 2 2020-05-22 This study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.
NCT04397510 Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury Not yet recruiting Phase 4 2020-06-01 Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19
NCT04398004 Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early Recruiting Phase 2 2020-05-06 Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
NCT04399356 Niclosamide for Mild to Moderate COVID-19 Not yet recruiting Phase 2 2020-06-01 This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).
NCT04399746 Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19 Recruiting N/A 2020-03-15 As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.
NCT04399980 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation Recruiting Phase 2 2020-05-20 The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
NCT04400799 Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19 Not yet recruiting Phase 3 2020-06-01 The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.
NCT04400929 Using GM-CSF as a Host Directed Therapeutic Against COVID-19 Not yet recruiting Phase 2 2020-06-01 The coronavirus disease 2019 (COVID-19) has rapidly become a pandemic. COVID-19 poses a mortality risk of 3-7%, rising to 20% in older patients with co-morbidities. Of all infected patients, 15-20% will develop severe respiratory symptoms necessitating hospital admission. Around 5% of patients will require invasive mechanical ventilation, and up to 50% will die. Evidence in severe COVID-19 suggests that these patients experience cytokine storm and progressed rapidly with acute respiratory distress syndrome and eventual multi-organ failure. Early identification and immediate treatment of hyperinflammation is thus recommended to reduce mortality. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) has been shown to be a myelopoietic growth factor that has pleiotropic effects in promoting the differentiation of immature precursors into polymorphonuclear neutrophils, monocytes/ macrophages and dendritic cells, and also in controlling the function of fully mature myeloid cells. It plays an important role in priming monocytes for production of proinflammatory cytokines under TLR and NLR stimulation. It has a broad impact on the processes driving DC differentiation and affects DC effector function at the mature state. Importantly, GM-CSF plays a critical role in host defense and stimulating antiviral immunity. Detailed studies have also shown that GM-CSF is necessary for the maturation of alveolar macrophages from foetal monocytes and the maintenance of these cells in adulthood. The known toxicology, pharmacologic and safety data also support the use of Leukine® in hypoxic respiratory failure and ARDS due to COVID-19. This study aims to recruit patients with evidence of pneumonia and hypoxia who have increased risk for severe disease and need for mechanical ventilation. The overall hypothesis is that GM-CSF has antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung with acute lung injury from COVID-19, and can promote lung repair mechanisms, which would lead to improvement in lung oxygenation parameters.
NCT04401150 Lessening Organ Dysfunction With VITamin C - COVID Not yet recruiting Phase 3 2020-06-01 LOVIT-COVID is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in hospitalized COVID-19 patients.
NCT04401293 Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients Recruiting Phase 3 2020-04-26 The aim of this study is to test the hypothesis that prophylaxis of severe COVID-19 patients with treatment dose LMWH leads to better thromboembolic-free outcomes and associated complications during hospitalization than prophylaxis with institutional standard of care with prophylactic to intermediate-doses of UFH or LMWH
NCT04401527 Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite Not yet recruiting Phase 2 2020-06-01 This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.
NCT04402203 Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh Recruiting Phase 2/Phase 3 2020-05-01 A recent outbreak of coronavirus disease 2019 (COVID-19) caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in Wuhan, China, at the end of 2019. The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnea, and pneumonia. As of 25 February 2020, at least 77 785 cases and 2666 deaths had been identified across China and in other countries; in particular, 977 and 861 cases were identified in South Korea and Japan, respectively. The outbreak has already caused global alarm. On 30 January 2020, the World Health Organization (WHO) declared that the outbreak of SARS-CoV-2 constituted a Public Health Emergency of International Concern (PHEIC), and issued advice in the form of temporary recommendations under the International Health Regulations (IHR).It has been revealed that SARS-CoV-2 has a genome sequence that is 75%-80% identical to that of SARS-CoV, and has more similarities to several bat coronaviruses. SARS-CoV-2 is the seventh reported human-infecting member of the family Coronaviridae, which also includes SARS-CoV and the Middle East respiratory syndrome (MERS)-CoV. It has been identified as the causative agent of COVID-19. Both the clinical and the epidemiological features of COVID-19 patients demonstrate that SARS-CoV-2 infection can lead to intensive care unit (ICU) admission and high mortality. About 16%-21% of people with the virus in China have become severely ill, with a 2%-3% mortality rate. However, there is no specific treatment against the new virus. Therefore, it is urgently necessary to identify effective antiviral agents to combat the disease and explore the clinical effect of antiviral drugs. One efficient approach to discover effective drugs is to test whether the existing antiviral drugs are effective in treating other related viral infections. Several drugs, such as ribavirin, interferon (IFN), Favipiravir (FPV), and Lopinavir (LPV)/ritonavir (RTV), have been used in patients with SARS or MERS, although the efficacy of some drugs remains controversial. It has recently been demonstrated that, as a prodrug, Favipiravir (half maximal effective concentration (EC50) = 61.88 μmol·L−1, half-maximal cytotoxic concentration (CC50) > 400 μmol·L−1, selectivity index (SI) > 6.46) effectively inhibits the SARS-CoV-2 infection in Vero E6 cells (ATCC-1586). Furthermore, other reports show that FPV is effective in protecting mice against Ebola virus challenge, although its EC50 value in Vero E6 cells was as high as 67 μmol·L−1. Therefore, clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral nucleoside for COVID-19 treatment. After enrollment of the patients (day 1) depending on inclusion and exclusion criteria and laboratory findings confirming the presence of the COVID-19 virus, 25 patients will receive Favipiravir plus standard treatment and the second group of 25 patients will receive standard treatment only. The comparison of the findings of the follow up studies on days 4, 7, and 10 in terms of clinical manifestations, chest X-ray and laboratory findings, such as Real Time Polymerase Chain Reaction (RT-PCR) results for viral presence will determine whether Favipiravir has safety and efficacy against COVID-19 infections. All ethical issues related to this trial including right of the participants to withdraw from the study should be maintained according to of guidelines of International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
NCT04402957 LSALT Peptide vs. Placebo to Prevent ARDS and Other Organ Injuries in Patients Infected With SARS-CoV-2 (COVID-19) Not yet recruiting Phase 2 2020-07-01 To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.
NCT04403100 Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" Not yet recruiting Phase 3 2020-05-28 The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
NCT04403555 Ivermectin and Doxycycine in COVID-19 Treatment Not yet recruiting Phase 2/Phase 3 2020-06-01 Efficacy of Ivermectin and Doxycycline in COVID-19 treatment
NCT04403685 Safety and Efficacy of Tocilizumab in COVID-19 and Inflammatory Markers: a Phase III Randomized Controlled Trial Recruiting Phase 3 2020-05-08 The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization.
NCT04404361 PRE-VENT Phase 3 Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer Not yet recruiting Phase 3 2020-05-22 This is a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer.
NCT04405271 TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study) Not yet recruiting Phase 3 2020-06-15 A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.
NCT04405570 A Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19 Not yet recruiting Phase 2 2020-05-26 This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19
NCT04405921 Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 Not yet recruiting Phase 3 2020-05-01 This study investigates the efficay and tolerance of 5-days course of hydroxychloroquine or hydroxychloroquine and azithromycin of patients with COVID-19 infection. We will undertake a randomized, double-blind, controlled Trial in the region of Sousse Tunisia
NCT04405999 Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease Recruiting Phase 4 2020-05-14 This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
NCT04406246 Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide Recruiting Phase 4 2020-05-21 The new coronavirus outbreak has led to a public health emergency of international concern, putting all health organizations on high alert. As part of the hygienic measures, isolation and reinforcement cleaning strategies have been followed. It is known that special attention and efforts should be applied to protect or reduce transmission in susceptible populations, including the elderly or those with comorbidities.It has also been proposed a semaforization to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough, headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis, chest pain, diarrhea, anosmia, ageusia. Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA, including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory Syndrome (MERS). Facing the lack of options against COVID-19 outbreaks for example in health workers, nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus reducing at the same time the Hospital saturation of patients positive to this virus.
NCT04407130 Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection. Not yet recruiting Phase 2 2020-06-01 Burden: Initial outbreak of corona virus disease 2019 (COVID-19) was reported from Wuhan, China in early December 2019 Presently known to be caused by a novel beta-corona virus, named as Severe acute respiratory syndrome corona virus 2 ( SARS-CoV-2) World Health Organization (WHO) declared a pandemic on March The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnoea and pneumonia Infected individuals exhibit: 1. Mostly mild illness (80% +) recover without any treatment (~80%) 2. Moderate illness that needs hospitalization and recovers after standard 3. supportive treatment (~14%) 4. Critical illness (~5%) needs ICU support 5. Death (1-2% ) COVID-19 has now spread >210 countries and territories globally SARS-CoV-2 is a respiratory virus which spreads primarily through droplets generalized when an infected person coughs or sneezes or through droplets of saliva or discharge from the nose Symptomatic management remains the mainstay of treatment strategy Mortality appears to be more common in older individuals and those with co-morbidities, such as chronic lung disease, cardiovascular disease and diabetes Young people with no comorbidities also appear to be at risk for critical illness including multi-organ failure and death. Seen more in Bangladesh between 21-40 yrs of age Knowledge Gap: There is no specific treatment against this new virus that WHO has officially declared until now There are many pharmacologic therapies that are being used or considered for treatment of COVID-19 National Guidelines on Clinical Management of Corona virus Disease 2019 (Covid-19): V 5.0 date 9th April 2020) CDC, DGHS, GoB Thus an RCT is urgently needed in Bangladesh: Based on recent literatures on Rx studies in COVID-19 patients from other countries as well as its availability & affordability of those repurposed medicines
NCT04408456 Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 Recruiting Phase 3 2020-03-01 Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well established pandemic worldwide. After Italy, Spain, Germany, United Kingdom and USA, India is at the edge of becoming the next epicentre of this Pandemic. If adequate preventive and therapeutic measures are not taken, India has very high risk of affecting million of people with high mortality because of the large population along with very high population density. At present there are no definitive therapeutic drugs or vaccine are available for the treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being given to COVID-19 cases along with isolation and quarantine measure are being taken for the suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection . Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ), has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients for lifelong without much side effect, so it allow for higher dose without any significant side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of the SARS-CoV-2 infection and many governments including USA and India have already endorse that due to lack of any other better alternative drugs. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for the people who are at risk for developing SARS-CoV-2 infection, all asymptomatic health care workers involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic household contacts of labarotory confirmed COVID-19 cases. But there is still lack of significant scientific data to prove or disprove the efficacy of HCQ for the treatment and post exposure chemo-prophylaxis for SARS-CoV-2 infection. Being a tertiary care centre we are catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar Pradesh. Among this Punjab have highest population of non residential Indian (NRI) and most of them have returned home. This put our institute to handle highest burden of suspected cases of SARS-CoV-2 in northern India. So we have planned this open level control clinical trial to evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for the prevention of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. As a research institute of national as well as international interest, it is a great opportunity for us to produce such a robust data which can be utilized in reforming national and international guidelines for the battle against of COVID-19 pandemic. All asymptomatic individuals who have undertaken international travel in last 2 weeks and all asymptomatic individual with direct contact with laboratory confirmed cases will be advised for home quarantine for 2 weeks along with social distancing and personal hygiene. They will be given the option for taking HCQ prophylaxis. These quarantined asymptomatic individuals will be assigned into one post exposure prophylaxis (PEP) group and one control group as per inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be directly included in the control group. All symptomatic individual, and all health care workers related to suspected or proven COVID-19 will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will not receive HCQ. Both the groups will receive standard care of therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene. They will be followed up for 4 weeks telephonically or physically as and when required and will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore throat, shortness of breath, diarrhoea, myalgia. If any asymptomatic individual become symptomatic they will be admitted for SARS-Cov-2 testing and will be managed accordingly with best possible care in the institute's communicable disease ward under isolation. Only the symptomatic individual with RTPCR positive for SARS-CoV-2 will be defined as confirmed COVID-19 case and negative symptomatic individual will be defined as probable COVID-19 case. Incidence of confirmed or probable COVID-19 case in asymptomatic quarantined individuals will be compared between the PEP and control groups.
NCT04409327 Phase 3 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes Recruiting Phase 3 2020-05-01 The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19
NCT04409873 Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19) Not yet recruiting Phase 2 2020-07-01 In this pilot trial, 120 confirmed COVID-19 individuals will be randomly assigned to 1 of 4 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), or Crest Pro-Health Multi-Protection (Crest, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 15 seconds, for 4 weeks.
NCT04409925 DISmantling COvid iNduced Neutrophil ExtraCellular Traps (DISCONNECT-1) Not yet recruiting Phase 1 2020-06-01 This is a pilot study to investigate the safety and tolerability of rhDNase1 and its impact on neutrophil extracellular traps (NETs) in COVID-19 infected patients
NCT04410328 Aggrenox To Treat Acute Covid-19 Not yet recruiting Phase 3 2020-06-21 The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19. An anticipated total of 132 participants will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and laboratory outcomes of all the participants enrolled in the study will be evaluated at the end of the study to explore if there is any difference in the outcomes between 2 groups.
NCT04410354 Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19 Not yet recruiting Phase 2 2020-06-01 The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.
NCT04410510 Randomized Double-blind Study in Subjects With SARS-Cov-2 (COVID-19) Virus Infection Not yet recruiting Phase 2/Phase 3 2020-06-01 Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.
NCT04411433 Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19 Recruiting Phase 3 2020-05-08 This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
NCT04411602 Feasibility Study of Anti-SARS-CoV-2 Plasma Transfusions in COVID-19 Patients With SRD Recruiting Phase 1 2020-04-07 Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.
NCT04411667 Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection Recruiting Phase 4 2020-04-28 The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. He wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.
NCT04411680 Study of Sargramostim in Patients With COVID-19 Not yet recruiting Phase 2 2020-06-01 The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from the effects of COVID-19, and this research study will help to find this out.
NCT04412395 Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease Not yet recruiting Phase 2 2020-06-01 The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
NCT04414098 Ruxolitinib in the Treatment of Covid-19 Not yet recruiting Phase 2 2020-06-01 The treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally every 12 hours during 14 days would stop the disproportionate inflammatory response, causing a reduction in the proportion of patients who show a progression and worsening of the severe acute respiratory syndrome.
NCT04415060 SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival Not yet recruiting Phase 3 2020-06-15 Around1 in 4 COVID-19 patients suffer lung failure needing life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs we give through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines. Another way to provide sleep is by using gases that you breathe in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies. This research is a study being carried out in a number of hospitals that will compare how well patients recover from this illness depending on which type of sedation drug they receive. We will evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Finally, this trial will be a team of experts in sedation drugs who care for COVID-19 patients who need lifesaving treatments.
NCT04415073 A Phase 2 Study to Evaluate Axatilimab for Hospitalized Patients With Respiratory Involvement Secondary to COVID-19 Recruiting Phase 2 2020-05-30 This is a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care, compared with placebo plus standard of care, in patients with respiratory signs and symptoms secondary to novel coronavirus disease (COVID-19).
NCT04416334 PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 70 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19) Not yet recruiting Phase 3 2020-05-25 This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 70 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 1000 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
NCT04417257 Study of LAU-7b for the Treatment of COVID-19 Disease in Adults Not yet recruiting Phase 2 2020-06-08 A randomized, double-blind, placebo-controlled Phase 2 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.
NCT04418128 Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia Not yet recruiting Phase 2/Phase 3 2020-05-25 In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19. This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
NCT04420741 Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure Not yet recruiting Phase 2 2020-06-01 The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 80 patients with COVID-19 suffering from respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in COVID-19 patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival. Given that the pulmonary system, apart from the brain, is the most highly vascularized vital organ in the body, extensive endothelial damage is a central feature of acute respiratory distress syndrome (ARDS) with respiratory failure being the rationale for the current study COMBAT-COVID-19.
NCT04421534 Utility of Lactoferrin as an Adjunct Therapeutic Agent for COVID-19 Not yet recruiting Phase 2/Phase 3 2020-06-01 There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, remains the most important management strategy. Since its discovery, lactoferrin and its related peptides are mainly considered to be important non-specific host defense molecules against a broad range of viruses including SARS-CoV, which is closely related to SARS-CoV-2 that causes COVID-19. Lactoferrin has been found to experimentally inhibit viral entry in murine coronavirus, and human coronaviruses hCOV-NL63 and pseudotyped SARS-CoV. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry. Another major aspect of lactoferrin bioactivity relates to its immunomodulatory and anti-inflammatory functions. Current thinking suggests that mortality from COVID-19 is not simply due to viral infection but is a result of a cytokine storm associated with hyper-inflammation leading to acute respiratory distress and subsequent mortality. A cytokine profile in severe COVID-19 cases is characterized by increases in cytokines and acute phase reactants and ferritin. In this regard, lactoferrin was demonstrated to reduce IL-6, TNF a, and downregulate ferritin in experimental settings simulating sepsis. In this study, we aim to study the potential application of lactoferrin against SARS-CoV-2 and propose the possibility of using different doses of supplemental lactoferrin as a potential adjunct treatment for COVID-19.
NCT04421664 Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada) Recruiting Phase 3 2020-03-25 Study Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
NCT04423861 Efficacy and Safety of Nitazoxanide 600 mg TID for the Treatment of Hospitalized Patients With COVID-19 Not yet recruiting Phase 2 2020-07-01 This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg TID) to treat hospitalized patients with non-critical COVID-19.
NCT04425031 Handling Oxygenation Targets in COVID-19 Not yet recruiting Phase 4 2020-08-01 Patient with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adults COVID-19 patients with hypoxaemic respiratory failure at ICU admission.
NCT04425538 A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19). Recruiting Phase 2 2020-06-01 We hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.
NCT04425707 Ivermectin In Treatment of COVID 19 Patients Recruiting N/A 2020-06-09 as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
NCT04427098 Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients Recruiting Phase 2 2020-05-22 General objective of the study To assess the efficacy and safety of enoxaparin in hospitalized patients with moderate to severe COVID-19 (Coronavirus Disease 2019) infection. Study Design The study consists of two parts: - a phase II single-arm interventional prospective study including all patients treated with the study drug; - an observational prospective cohort study including all patients screened for receiving the study drug but not included in the phase II study. Patients will be enrolled from "date of study approval" for 1 month. Each patient will be followed-up for a minimum of 90 days after COVID19 diagnosis.
NCT04427865 Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19 Not yet recruiting Phase 2/Phase 3 2020-07-01 COVID 19, which probably started from zoonotic transmission related to crowded markets in China was announced as a pandemic by the WHO on 11 March 2020. There is currently no clinically proven specific antiviral agents available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy. Since its discovery, lactoferrin and its related peptides are considered non-specific host defense molecules against a broad range of viruses including SARS-CoV, which is closely related to SARS-CoV-2 that causes COVID-19. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry and has an immunomodulatory effect that can prevent the cytokine storm associated with COVID-19. The aim of our study is to assess the safety and efficacy of lactoferrin within the context of SARS-CoV-2 and propose the possibility of supplemental lactoferrin as a potential preventive drug for healthcare workers exposed to SARS-CoV-2.
NCT04428008 Thymosin Alpha 1 to Prevent COVID-19 Infection in Elderly Renal Dialysis Patients Not yet recruiting Early Phase 1 2020-06-01 Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals with ESRD will reduce the rate and severity of infection with COVID-19.
NCT04428021 Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure Not yet recruiting Phase 2 2020-06-15 To date no specific treatment has been proven to be effective for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that contains antibodies to SARS-Cov-2 might be effective against the progression of infection. Promising results have been shown by preliminary data from China cases. The investigators planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best evidence based therapy approved for treatment of COVID patients by regional Health system emergency committee.
NCT04429555 Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS Not yet recruiting Phase 2 2020-07-31 The study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and Day 28.
NCT04429867 Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease Active, not recruiting Phase 4 2020-05-07 The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
NCT04432298 Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Patients With Acute COVID-19 Disease Not yet recruiting Phase 2 2020-06-01 This is a Phase 2 trial to evaluate the efficacy and safety of intravenous (IV) infusions of pamrevlumab as compared to placebo in hospitalized subjects with acute COVID-19 disease.
NCT04432987 Dornase Alpha for the Treatment of COVID-19 Recruiting Phase 2 2020-05-25 In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately.
NCT04433546 PB1046, a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS). Not yet recruiting Phase 2 2020-06-26 This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of respiratory failure in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.
NCT04433910 A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19 Not yet recruiting Phase 2 2020-06-01 This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19. The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of patients with severe COVID-19. Convalescent plasma will be collected from recovered COVID-19 patients. Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients in the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline, patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19. Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.
NCT04434131 Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19 Recruiting Phase 2 2020-04-28 This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.
NCT04434248 An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19 Active, not recruiting Phase 2/Phase 3 2020-04-23 The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
NCT04435184 Crizanlizumab for Treating COVID-19 Vasculopathy Not yet recruiting Phase 2 2020-06-01 The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.
NCT04435314 Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 Not yet recruiting Phase 2 2020-06-01 The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.
NCT04435717 Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01) Recruiting Phase 2 2020-05-04 unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
NCT04437693 Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients Not yet recruiting Phase 3 2020-07-01 More cases of COVID-19 pandemic are being reported daily around the world. It is highly infectious and, over 7 million people have been infected and more than 400,000 people have died globally till this date. Countries around the world are struggling to avoid the spread of this pandemic. Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs for COVID-19 treatment. Researchers around the globe, however, are researching different medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know how well all of these medications are functioning. Therefore, we aim to perform a randomized placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare workers exposed while treating COVID 19 patients in Qatar to avoid causality and comorbidities in healthcare workers. It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a result of which they are initially taken up into an intracellular compartment that is "typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the first place. An interventional, double-blind, placebo-controlled randomized trial that will include participants who will be healthcare workers at risks of exposure to COVID-19 while managing patients with confirmed infection. Our study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP) use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to Placebo in Qatar.
NCT04438837 Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers: A Randomized-Controlled Trial Not yet recruiting N/A 2020-06-01 Background: The rapid spread and high infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important. One of the important target populations for such intervention who are at high risk of exposure are health care workers (HCWs) who may develop disease and/or expose patients and other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus replication and immunomodulation, an important role in the inhibition of pre-entry step of the virus to host cells. Such activity in the early stage of infection may play a role in prevention of disease progression. Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of viral shedding among HCWs following exposure to confirmed COVID-19 patients. Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a confirmed case of COVID-19 without full adherence to droplet precautions. Participants will be eligible in a period no longer than 72 hours after exposure. Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days. Participants in the control group will receive no treatment. Treatment will be started no longer than 72 hours following exposure. Outcomes: The primary outcome will be the number of participants who develop clinical signs compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary outcomes will include virologically-confirmed COVID 19, disease severity (need for hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration (time between first positive PCR to last of two consecutive negative tests) for confirmed COVID 19 cases. Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a power of 80% (alpha 0.05) is 291 participants per each group.
NCT04439006 Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization Not yet recruiting Phase 2 2020-06-15 This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.
NCT04440007 Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With SOC Versus SOC in Subjects With COVID-19 Not yet recruiting Phase 2 2020-08-01 Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19
NCT04441385 Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19). Not yet recruiting Phase 2 2020-06-26 This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19).
NCT04441398 Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients Not yet recruiting Phase 2/Phase 3 2020-07-01 The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
NCT04441424 Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients Completed N/A 2020-04-03 Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.
NCT04443270 Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients Not yet recruiting Phase 1 2020-06-22 The primary objective of this study is to evaluate the efficacy and security of chloroquine phosphate prophylactic use for reducing the risk of infection by severe acute respiratory syndrome coronavirus-2 in Health Care Workers exposed to COVID-19 patients.
NCT04445246 Inhaled Iloprost for Suspected COVID-19 Respiratory Failure Recruiting Phase 2 2020-05-23 Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.
NCT04445272 Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia Recruiting Phase 2 2020-05-22 At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in other pathologies several clinical trials and observational studies are being conducted to assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with a large sample size are required to confirm the effectiveness of tocilizumab in patients with COVID-19 pneumonia. The need for the management of severe COVID-19 disease is imperative, and every effort should be made to collect relevant clinical outcomes. The aim of the present study is to evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are currently hospitalized or admitted to ICU by describing improvement of respiratory function and mortality rate. This large real-world cohort therefore provides a unique opportunity to study this potential medicine during the current emergency situation, and support the findings from other ongoing clinical trials and observational studies, such as the Roche-sponsored Phase III study that is planned to start early April.
NCT04445389 Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults Recruiting Phase 1/Phase 2 2020-06-17 The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
NCT04445623 Prasugrel in Severe COVID-19 Pneumonia Not yet recruiting Phase 3 2020-07-01 Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH) is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and platelet activation may promote thrombosis and amplify inflammation, as indicated by previous experimental evidence , and the similarities with atherothrombosis and thrombotic microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context of venous thromboembolism. The use of purinergic receptor P2Y12 inhibitors in pneumococcal pneumonia may improve inflammation and respiratory function in humans. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider a P2Y12 inhibitor for the prevention of thrombosis in the pulmonary circulation and attenuation of inflammation. This is supported by numerous demonstrations of the anti-inflammatory activity of P2Y12 inhibitors and the evidence of improvement in respiratory function both in human and experimental pathology. We considered prasugrel as an ideal candidate drug for Covid-19 patients because of higher efficacy and limited Interactions with drugs used in the treatment of Sars-CoV2. The hypothesis underlying the present study project is that in Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with a P2Y12 inhibitor could be superior to fixed dose enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory drugs, antibiotics), except for specific contraindications.
NCT04445935 Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial Recruiting Phase 4 2020-06-28 Patients with COVID-19 associated ARDS and mechanical ventilation have a high mortality. Part of the disease is an activation of the coagulation system which seems to contribute to clotformation in the pulmonary bloodstream. Recently we implemented an algorithm applying higher doses of heparins (LMWH). However, this approach could not inhibit clotformation enough. Bivalirudin could prevent clotformation better and support dissolving existing clots. Therefore, we want to compare 50 patients with the standard treatment with 50 patients under bivalirudin treatment which we normally apply in patients with a HIT-syndrome. Our primary outcome measure is oxygenation reflected as P/F ratio.
NCT04446065 Protection of Health Workers Against COVID-19 Not yet recruiting Phase 2/Phase 3 2020-07-30 The purpose of this clinical trial is to determine the efficacy of Previfenon® (EGCG) to prevent COVID-19, enhance systemic immunity, and decrease the frequency and intensity of selected symptoms when used as pre-exposure chemoprophylaxis to SARS-CoV-2.
NCT04447235 Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection Not yet recruiting Phase 2 2020-07-01 Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
NCT04447534 Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19 Recruiting Phase 3 2020-06-23 we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.
NCT04448119 Control of COVID-19 Outbreaks in Long Term Care Not yet recruiting Phase 2 2020-06-01 To address the need to intervene to prevent the spread of COVID-19 in long-term care homes, we propose a randomized clinical trial of chemoprophylaxis in long-term care homes experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio. Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy for outbreak control. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.
NCT04449965 Povidone-Iodine Rinses in the Management of COVID-19 Not yet recruiting Early Phase 1 2020-07-01 The aim of this study is to determine if Povidone iodine (PVP-I) rinses and throat gargles or a PVP-I gel forming nasal spray compared to a placebo (a treatment that has no physical effect to a person) is an effective treatment for patients diagnosed with COVID-19. These patients have been diagnosed with mild/moderate COVID-19 symptoms and sent home for self-isolation. Patients will be instructed to take either of the two treatments or placebo twice daily for two weeks and have follow up visits 2 and 4 weeks after. The participants will also complete study related procedures such as saliva sample collection, and two questionnaires throughout the study period. The investigators hypothesize that COVID 19 positive participants who use either of the Povidone - Iodine treatment will have a reduction in their viral load, develop a negative oral mucosa sample and improve their clinical symptoms.
NCT04451239 Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis Not yet recruiting N/A 2020-06-30 To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in COVID-19 patients with acute keratoconjunctivitis.
NCT04452474 Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19). Not yet recruiting Phase 2/Phase 3 2020-06-30 The primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64 mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 29.
NCT04452669 VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation Not yet recruiting Phase 2 2020-07-31 The purpose of this study is to investigate whether inhaled epoprostenol given via a breath actuated delivery system will help improve oxygen levels and treatment outcomes in patients with COVID-19 who are on mechanical ventilation.
NCT04452799 Hesperidin and Diosmin for Treatment of COVID-19 Not yet recruiting Early Phase 1 2020-07-01 SARS-CoV-2 or COVID-19 is representing the major global burden that implicated more than 10 million infected cases and 500 thousand deaths worldwide. The prevalence of this pandemic disease is expected to rise every day. The challenge is to control its rapid spread meanwhile looking for a specific treatment to improve patient outcomes. Hesperidin is a classical herbal medicine used worldwide for a long time with an excellent safety profile. Hesperidin is a well-known herbal medication used as an antioxidant and anti-inflammatory agent. Available shreds of evidence support the promising use of hesperidin in prophylaxis and treatment of COVID 19. Herein, we discuss the possible prophylactic and treatment mechanisms of hesperidin based on previous and recent findings. Hesperidin can block coronavirus from entering host cells through ACE2 receptors which can prevent the infection. Anti-viral activity of hesperidin might constitute a treatment option for COVID-19 through improving host cellular immunity against infection and its good anti-inflammatory activity may help in controlling cytokine storm. Hesperidin mixture with diosmin co-administrated with heparin protect against venous thromboembolism which may prevent disease progression. Based on that, hesperidin might be used as a meaningful prophylactic agent and a promising adjuvant treatment option against SARS-CoV-2 infection.
NCT04453371 Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19) Not yet recruiting Phase 3 2020-07-01 At the beginning COVID-associated lung injury was considered as typical ARDS, hence respiratory and nonrespiratory treatments were delivered according to general principles for this kind of illness. There is hypothesis that in predisposed individuals, alveolar viral damage is followed by an inflammatory reaction and by microvascular pulmonary thrombosis. The investigators suggest that thrombolytic therapy may be beneficial when compared to standard care in patients with SARS-CoV-2 and severe respiratory failure.
NCT04454307 Afety and Efficacy of Tramadol Tramadol in COVID-19 Egyptian Patients Not yet recruiting Phase 1/Phase 2 2020-07-01 The rationale of the use of tramadol for COVID-19 patients is attributed to its anti-inflammatory, hypocagulatory, antioxidant, cardio-protective, analgesic, antitussive, bactericidal and antidepressant effect.
NCT04454398 A Randomized Placebo-controlled Study to Evaluate STI-1499 (COVI-GUARD) in Hospitalized Patients With COVID-19 Not yet recruiting Phase 1 2020-08-01 Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics, preliminary efficacy of three dose levels of a single dose of STI-1499 (COVI-GUARD), a COVID-19 targeting monoclonal antibody, in hospitalized patients with COVID-19
NCT04455815 A Trial Looking at the Use of Camostat to Reduce Progression of Symptoms of Coronavirus (COVID-19) in People Who Have Tested Positive But Are Able to Stay at Home Not yet recruiting Phase 2/Phase 3 2020-06-22 This is a phase II/III randomised, multi-centre, prospective, open label, community-based clinical trial. The trial aims to recruit patients who test positive for COVID-19 but who have mild disease and therefore can treat their symptoms in the community. Patients who seek testing and have a confirmed positive test result will be invited to enrol in the trial.
NCT04456153 Atovaquone for Treatment of COVID-19 Not yet recruiting Phase 2 2020-07-01 The purpose of the current study is to accelerate the use of a clinically available therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19 addressing a serious and emergent unmet medical need. This is a randomized, double-blind study of atovaquone therapy in adult participants hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment groups: Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days Treatment Group 2: continued standard of care therapy together with matching placebo
NCT04457609 Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients Recruiting Phase 1 2020-07-01 Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
NCT04458363 Convalescent Plasma in Pediatric COVID-19 Recruiting Early Phase 1 2020-07-01 COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
NCT04459247 Short Term, High Dose Vitamin D Supplementation for COVID-19 Recruiting N/A 2020-06-15 Coronavirus-2019 (COVID-19) caused by severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) has affected the lives of millions of individuals globally and severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe disease. The transmission potential of SARS CoV-2 is potentially greator than earlier viral outbreaks of SARS-CoV and MERS-CoV. Identification of asymptomatic carriers of SARS-CoV-2 infection is paramount to contain viral infection because of high transmission potential Routine measures of social distancing, personal hand hygiene and limited outdoor contact activities have shown benefits to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is not explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. It has been found that mortality from COVID-19 is more in countries with vitamin D deficiency. The role of therapeutic vitamin D supplementation in asymptomatic individuals with vitamin-D deficiency and COVID-19 is not known. Immune-modulatory effect of vitamin D is likely to be observed at 25(OH)D levels which are considered higher than that required for normal bone metabolism.An earlier SARS-CoV-2 negativity may have significant public health benefits in limiting the spread of the disease. Therefore, we hypothesise that high dose vitamin D supplementation in patients with COVID-19 and vitamin D deficiency may lead to SARS-CoV-2 negativity in greater proportions of patients associated with decrease in serological markers of inflammation.
NCT04459286 The Nitazoxanide Plus Atazanavir for COVID-19 Study Not yet recruiting Phase 2 2020-08-01 Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans. In this pilot study, 98 COVID-19 patients will be recruited into two group. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days. The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.
NCT04460183 A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 Not yet recruiting Phase 2/Phase 3 2020-07-06 The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.
NCT04460443 Sofosbuvir With and Without Ribavirin in Treatment of COVID 19 Not yet recruiting Phase 2/Phase 3 2020-08-01 Sofosbuvir with and without ribavirin in treatment of COVID 19 Egyptian patients
NCT04461340 Efficacy and Safety of Sirolimus in COVID-19 Infection Not yet recruiting Phase 2 2020-07-25 This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection
NCT04461925 Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs Recruiting Phase 1/Phase 2 2020-05-02 Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute respiratory distress syndrome.
NCT04462757 SCIL-1Ra in COVID-19 Feasibility & PK/PD Recruiting Phase 2 2020-05-28 The current COVID-19 pandemic is a worldwide healthcare crisis. Of concern is the large number of patients that are/will require mechanical ventilation, and the associated strain that this will place on healthcare resources. At present, there are no specific therapeutic interventions directed at COVID-19 infection. However, observational data suggest that there is a subgroup of patients that demonstrate a hyperinflammatory response in response to COVID-19 and have a higher requirement for Critical Care and higher mortality. There is a strong case for the use of the naturally occurring anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1Ra) in these patients. Anakinra is a recombinant form of IL-1Ra that is licensed for clinical use. Success of use of anakinra in COVID-19 trials will be greatly enhanced by robust scientific evidence and established pharmacokinetics which inform the most effective dosing regimens. The latter is especially important when, as in the case of anakinra, drug supplies are limited, the drug has short half-life and clinical ease of application is critical.
NCT04463004 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation Recruiting Phase 2 2020-08-01 The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
NCT04463264 Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19) Recruiting Phase 2/Phase 3 2020-06-26 Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.
NCT04463602 Desidustat in the Management of COVID-19 Patients Not yet recruiting Phase 2 2020-07-15 This study is a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of mild, moderate and severe COVID-19 patients. 100 mg of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial.
NCT04466540 Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19) Recruiting Phase 4 2020-05-12 In December 2019, a group of patients with pneumonia of unknown cause was identified in Wuhan, in the Hubei province, China. Despite the need of target specific therapeutic options for COVID-19, until now there is no proof of effectiveness of any specific intervention. Some limited observational trials and also evidence from randomized trials have shown no benefit of hydroxychloroquine in inpatient context. Thus, studies evaluating interventions in an outpatient setting in non-severe patients can provide important information related to prognosis and safety. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine in COVID-19 outpatients by means of a Randomized, double-blind, placebo-controlled trial
NCT04467151 Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19 Not yet recruiting Phase 2 2020-08-01 The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).
NCT04468009 This Study Aims to Use Convalescent Plasma as Experimental Treatment in Critically Ill Patients With Covid-19 Recruiting Phase 2 2020-06-25 This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.
NCT04468646 To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients Recruiting Phase 3 2020-06-15 This is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients. Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
NCT04469114 Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia Not yet recruiting Phase 2 2020-08-07 Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and ARDS in patients with COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.
NCT04470297 Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19 Not yet recruiting Phase 2 2020-09-01 COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested as a potential protector against organ injuries and even mediate lower mortality rates after polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection. We proposed a clinical trial testing the effects of ramelteon 8mg in hospitalized patients with COVID-19.
NCT04470531 Role of Co-trimoxazole in Severe COVID-19 Patients Active, not recruiting Phase 2 2020-07-12 Coronavirus Disease 19 (COVID-19) is a global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Severe disease occurs in 15% of the cases with COVID-19 and may progress to critical disease in only 5% of the cases with a high risk of mortality. Critical disease may present as acute respiratory failure secondary to Acute Respiratory Distress Syndrome (ARDS) and is caused by the body's hyper-immune response to the virus in the form of a cytokine storm syndrome (CSS). There is currently no effective anti-viral treatment against SARS-CoV-2 and the mainstay of treatment is supportive. Co-trimoxazole (combination of trimethoprim and sulphamethoxazole in a 1:5) ratio is a Sulphur containing anti-folate bactericidal antibiotic indicated for the treatment of respiratory tract infections. It has been around for over 60 years and is inexpensive and readily available with a good safety profile. It has a rapid onset of action with excellent bioavailability and lung penetration. In addition to having antimicrobial properties co-trimoxazole have immunomodulatory and anti-inflammatory properties and may be a potential treatment option for cytokine storm syndrome mediated severe COVID-19. This open-label randomized controlled trial will be conducted in the department of medicine at Bangabandhu Sheikh Mujib Medical University (BSMMU), Anwar Khan Modern Medical college and Mughda Medical College Hospital (DMCH), Dhaka for a duration of 6 months following approval of this protocol. It will recruit at least 94 consecutive adults (18 years or older) patients with clinically suspected COVID-19 and severe illness as per WHO criteria. After taking informed written consent patients will be randomly assigned in a 1:1 ratio to either oral co-trimoxazole in addition to standard therapy or standard therapy alone. Baseline characteristics, changes in the physiological and biochemical parameters like (SpO2/FiO2 ratio, respiratory rate, body temperature and C - reactive protein), length of hospital stay, side effects of drugs, requirement for ventilatory support (non-invasive and invasive ventilation) and in-patient mortality between the two groups will be compared. Data will be collected from case record forms, anonymised and stored securely in a secure online web-based portal. Statistical analysis will be performed using t-test or Mann -Whitney U test or Wilcoxon signed rank test for continuous variables and Chi- square test or Fisher's exact test for categorical variables. Survival will be assessed by the Kaplan-Meier method. Comparisons between two groups will be performed using the Log-rank test and Hazard Regression test.A p-value of < 0.05 will be considered to be significant. The statistical software SPSS version 25 will be used for the analysis. Conclusion If the results from this clinical trial demonstrate the beneficial effects of co-trimoxazole in severe COVID-19 patients it could be used widely, thereby reducing the need for respiratory support and potentially saving thousands of lives in developing nations with limited resources where healthcare may be easily overwhelmed.
NCT04472585 Efficacy of Subcutaneous Ivermectin With or Without Zinc and Nigella Sativa in COVID-19 Patients Recruiting Phase 1/Phase 2 2020-07-14 To measure the effect of Ivermectin (sub-cutaneous) with or without zinc and Nigella sativa in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
NCT04473053 Rapid Experimental Medicine for COVID-19 Recruiting Phase 2/Phase 3 2020-07-03 COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, community based infected patients or hospitalised patients can be included. Products requiring parenteral administration will only be investigated in hospitalised patients. Patients will be divided into cohorts, a) community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation. Participants may be recruited from all three of these cohorts, depending on the experimental therapy, its route of administration and mechanism of action. The relevant cohort(s) for any given therapy will be detailed in the therapy-specific appendix. Candidate therapies can be added to the protocol and previous candidates removed from further investigation as evidence emerges. The trial will be monitored by an independent Data Monitoring Committee (DMC) to ensure patient safety. Each candidate cohort will include a small cohort of patients randomised to candidate therapy or existing standard of care management dependent on disease stage at entry. Cohort numbers will be defined in the protocol appendices. This is a Phase IIa experimental medicine trial and as such formal sample size calculations are not appropriate.
NCT04473170 Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19 Completed Phase 1/Phase 2 2020-04-04 SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were randomly allocated in a parallel assignment involving two groups of participants: Group A (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19 standard care. Standard care is defined as per the "UAE National Guidelines for Clinical Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell processing and investigational product formulation were completed by Abu Dhabi Stem Cells Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).
NCT04474483 Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 Not yet recruiting Phase 2 2020-08-11 This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.
NCT04475991 Safety and Efficacy of Maraviroc and/or Favipiravir vs Standard Therapy in Severe-non Critical COVID-19 Adults Not yet recruiting Phase 2 2020-07-01 Phase 2, randomized, open-label study to compare the safety and efficacy of maraviroc, favipiravir, and both drugs combined versus standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19)
NCT04476992 Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement Not yet recruiting Phase 1/Phase 2 2020-07-17 Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).
NCT04477642 Abatacept for Patients With COVID-19 and Respiratory Distress Withdrawn Phase 1/Phase 2 2020-08-01 This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level
NCT04479202 The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19 Completed Phase 4 2020-02-08 Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world, causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent multiple organ dysfunction (MODS) are important causes for disease progression and death in patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also highly expressed in the esophagus, small intestine and colon, suggesting that the gut might also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore, elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory response in the gut, which was significantly correlated with IL-6. For severe and critical cases, control "cytokine storms" and maintain intestinal microenvironment balance have been included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7). Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland secretion. Berberine has also been found to have a role in intestinal immune regulation, inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the inflammatory response. Investigators conducted a prospective randomized controlled clinical trial to investigate the effects of berberine on intestinal function, serum concentrations of the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.
NCT04480138 Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) Not yet recruiting Phase 2 2020-08-05 This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.
NCT04482621 Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial Recruiting Phase 2 2020-07-29 This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a total of 40 patients) to assess efficacy of decitabine in the treatment of critically ill patients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receive standard of care plus Decitabine or standard of care plus saline based placebo. The primary objective is to determine safety and efficacy of decitabine for COVID-19 ARDS based on clinical improvement on a 6-point clinical scale.
NCT04482673 Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection Recruiting Phase 4 2020-07-20 The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.
NCT04482712 Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS Not yet recruiting Phase 1/Phase 2 2020-10-01 This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.
NCT04483830 Suloexide in the Treatment of Early Stages of COVID-19 Recruiting Phase 2/Phase 3 2020-06-05 Problem: The COVID- 19 pandemic has not only affected our healthcare system, but the impact on the worldwide financial systems and our "normal" way of life is still to be determined. Although the percentage of patients infected with COVID-19 that need hospital care is low, Its high rate of contagiousness makes the total number of patients in need of hospital care cripple any healthcare system, limiting the space available for other patients in need of critical care, who cannot be admitted or even prefer not to attend the hospital in fear of infection. Early investigations report an Increase risk of thromboembolic complications, and a systemic inflammatory response not clearly understood. There is a possible vascular endothelial dysfunction due to chronic comorbidities (Hypertension, diabetes, obesity, chronic kidney disease, lung disease) as a risk factor for a more severe presentation. Justification: Sulodexide is a two-compound drug, each of them with different endothelial action that can be beneficial in COVID-19 patients. Glycosaminoglycans: Can help restore venous and arterial endothelial glycocalyx which can downregulate or limit the response to inflammatory molecules, by maintaining the integrity lost in certain chronic diseases (high blood pressure, diabetes). Heparin compound: It has an antithrombotic effect that could help reduce the incidence of thromboembolic complications, and also add to the anti-inflammatory response due to it anti-thrombin action (similar or a bit less to that of low molecular weight heparin) with less risk of major bleeding. It's a medication that can be used orally with minimal adverse effects and is less expensive than low molecular weight heparin. Hypothesis: We hypothesize that sulodexide instituted early in populations at significant risk and symptomatic patients affected with COVID-19 (shortness of breath, fever, weakness, diarrhoea) and risk factors of diabetes, hypertension, COPD, atherosclerosis, chronic kidney disease, will provide improvement in endothelial integrity, decrease inflammatory responses, and improved clinical outcomes with decreased hospital admission, decrease VTE and arterial complications, morbidity, and mortality. Objective: To use sulodexide in patients that have early onset of COVID-19 symptoms to mitigate the progression of the disease process that can allow them to recover at home, and limit the need of hospital care and a more severe clinical manifestation
NCT04484493 Corticosteroid Nasal Spray in COVID-19 Anosmia Not yet recruiting Phase 3 2020-08-01 The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (momentasonefuratenasal spray) in improving anosmia in patients recovered from COVID-19 infection.
NCT04485130 DISulfiram for COvid-19 (DISCO) Trial Not yet recruiting Phase 2 2020-09-01 Disulfiram a safe, easily dosed, FDA-approved drug for the treatment of alcohol dependence has been identified to be a potential therapeutic target for SARS-CoV-2 infection. Disulfiram may have both antiviral (inhibiting viral replication via blocking the Mpro protease and zinc ejection) and anti-inflammatory effects (via inhibition of NF-kB-induced and NLRP inflammasome-induced cytokine release) on SARS-CoV-2. We will test disulfiram 2000 mg/day for 3 consecutive days (doses shown to be well tolerated and safe in a recent phase 2b trial) in 60 symptomatic COVID PCR+ individuals in a randomized (1:1) clinical trial evaluating the effect on COVID symptoms severity, SARS-CoV-2 viral load, and biomarkers of inflammation over 31 days.
NCT04486313 Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 Not yet recruiting Phase 3 2020-07-30 Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
NCT04486508 Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19 Not yet recruiting Phase 3 2020-07-30 In a 2x2 factorial design randomized controlled trial, we aim to investigate the safety and efficacy of two pharmacological regimens on outcomes of critically-ill patients with COVID-19. The first randomization entails open-label assignment to intermediate versus standard dose prophylactic anticoagulation. We hypothesize that intermediate dose compared with standard prophylactic dose anticoagulation will have a superior efficacy with respect to a composite of venous thromboembolism (VTE), requirement for extracorporeal membrane oxygenation (ECMO), or all-cause mortality. The second randomization will be double-blind assignment of the included patients to atorvastatin 20mg daily versus matching placebo. The hypothesis is that statin therapy, compared with placebo, will reduce the composite of VTE, need for ECMO, or all-cause mortality.
NCT04487444 Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection Not yet recruiting Phase 2 2020-07-01 It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia. After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.
NCT04487574 A Study to Assess the Efficacy and Safety of XC221 in Patients With COVID-19 Not yet recruiting Phase 3 2020-07-01 The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2 infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in COVID-19 patients during a 14-day treatment. The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200 mg daily dose) in achieving clinical improvement of COVID-19 symptoms. The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg daily dose) in COVID-19 patients.
NCT04488081 I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients Not yet recruiting Phase 2 2020-07-25 The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.
NCT04491994 Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression Completed N/A 2020-04-10 Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19). As mortality in patients with critical category is quite substantial, hence every effort has to be made to intervene early and aggressively in order to prevent progression of disease. Globally, approximately eight million confirmed cases of Covid-19 have been reported with an outcome based overall mortality of 5.51% In Pakistan, there is exponential rise in Covid-19 cases in last few months. Nevertheless, data from various international studies shows that 81% of patients have had mild to moderate disease, which includes non-pneumonia and pneumonia cases. Management of mild disease is equally important as this is the main bulk involved in transmission of disease to others. It is well known fact that asymptomatic carriers and patients with mild disease are also the main sources of disease transmissibility. Therefore, it is a matter of utmost importance to detect mild cases earlier and start some investigational treatment in carefully selected hospitalized patients. Different investigational treatment options have been tried in different severity categories of COVID-19. Out of many therapeutic off-label options, HCQ seems more suitable owing to its known safety profile, side effects, posology and drug interactions6. HCQ has been found to have good in vitro activity against SARS-CoV-2and better safety profile than chloroquine. A small study on 36 patients shows that hydroxychloroquine (HCQ) treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients. Similarly, it has been hypothesized that HCQ might inhibit cytokine storm by reducing CD154 expression in T cells, thus reducing chances of disease progression.
NCT04492254 Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients Not yet recruiting Phase 3 2020-07-01 Evidence has shown that COVID-19 infections can lead to an increased risk of blood clots. These blood clots can lead to individuals being admitted to hospital, or, unfortunately in severe cases, death. Enoxaparin is a blood-thinning drug which has been used by doctors and nurses in hospitals for many years to prevent the thickening of blood which may lead to a clot. It is easier for doctors to prevent new blood clots from forming than treating existing blood clots. Currently, there are no treatments for COVID-19. There is an urgent need to find a safe and effective treatment to prevent worsening of the disease that may lead to hospital admission and/or death. The ETHIC (Early Thromboprophylaxis in COVID-19) study aims to find out if giving enoxaparin in an early stage of the COVID-19 disease can prevent individuals being admitted to hospital and/or death. The study will take place in approximately 8 to 10 countries, in approximately 30 to 50 centres. Patients will be allowed to take part if they have had a confirmed COVID-19 infection, are ≥ 55 years of age and have at least two of the following additional risk factors; age ≥ 70 years, body mass index > 25 kg/m2, chronic obstructive pulmonary disease, diabetes, cardiovascular disease, or corticosteroid use. Half the patients in the study will receive the blood-thinning drug enoxaparin for three weeks, and half will receive no treatment. Individuals will be randomly allocated to one of these groups. After 21 days, the number of patients in each group who were either admitted to hospital, or died, will be compared. The number of patients in each group who developed a blood clot (venous thromboembolism) will also be compared. Further comparisons will be made at both 50 and 90 days after the beginning of the study.
NCT04492501 Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan Completed N/A 2020-04-01 Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19) and related pneumonia, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).Investigators have seen recently from experience in Western countries with best health care systems that pandemics cannot be managed in hospitals. Investigators have seen ICUs crowded to capacity, healthcare workers being exposed and going to quarantine or dying after exposure to large doses of viral inoculums. Investigators recommend that institutions should register for Clinical trials and consider emergency use of TPE. In Pandemics, time is of essence to avoid mortality by intervening early with available evidence, preferably as part of clinical trial.Since the outbreak of corona virus disease (COVID-19), main treatment modalities have been antivirals, interferons, glucocorticoids, anti-coagulants and supportive treatment in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline / chloroquine sulphate, azithromycin, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small and remain in the experimental phase with currently no effective / specific antiviral with robust scientific evidence as regards the mortality reduction in COVID-19.In an attempt to treat COVID-19, investigator will use different investigational treatment either alone or in combination to see mortality and morbidity benefit on the basis of limitted evidence available so far. These investigational modalities include Therapeutic plasma exchange (TPE), Convalescent Plasma (CP), Remdesivir, Tocilizumab and Mesenchymal stem cell (MSC) therapy in addition to standard supportive treatment.
NCT04492514 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflation Recruiting Phase 2 2020-05-20 The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
NCT04492891 Cyclosporine For The Treatment Of Covid-19(+) Not yet recruiting Phase 2 2020-08-20 Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no CSA + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.
NCT04494399 IFN Beta-1b and Ribavirin for Covid-19 Recruiting Phase 2 2020-07-29 As of 1 July 2020, more than 10 million people been confirmed to have infected by SARS-CoV-2, resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is currently available, but existing medication could be repurposed. The investigators therefore propose to conduct an open-label randomized controlled trial on a short course of interferon β-1b and ribavirin combination treatment for patients hospitalized for COVID-19 infection.
NCT04494646 BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Not yet recruiting Phase 2/Phase 3 2020-08-01 This multi-center, double-blind, placebo-controlled, randomized Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in approximately 400-440 patients hospitalized with confirmed COVID-19. The Phase 2 portion of the trial will include approximately 40 patients and is designed to provide an early interim analysis of safety. The Phase 3 portion of the trial will include approximately 360-400 additional patients, and is designed to determine whether bardoxolone methyl increases the probability of recovery at Day 29 when compared with matching placebo. Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo and treatment will be administered for the duration of hospitalization (until recovery), with a maximum treatment duration of 29 days.
NCT04494724 Clazakizumab vs. Placebo - COVID-19 Infection Recruiting Phase 2 2020-07-13 The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.
NCT04495816 COVID-19 Anosmia Study Recruiting Phase 2 2020-07-15 To capture the natural history of COVID-19 associated olfactory dysfunction as measured by two patient reported outcome measures (SNOT-22, QOD-NS) and a 6-week BSIT with a comparison to an intervention arm receiving daily omega-3 supplements.
NCT04497649 Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients Recruiting Phase 2/Phase 3 2020-07-01 efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
NCT04497948 Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 Not yet recruiting Phase 1 2020-07-31 Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.
NCT04498273 COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-79 Not yet recruiting Phase 3 2020-08-01 A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis
NCT04498936 Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19 Recruiting Phase 4 2020-07-15 The efficacy of treating COVID-19 infection by using Sofosbuvir/Ledipasvir and Nitazoxanide will be examined. Included patients will be into 3 groups. The 1st group will receive Sofosbuvir/Ledipasvir plus the standard care treatment (SCT). The 2nd group will take Nitazoxanide and SCT, while the 3rd group will receive only SCT. Then the clinical improvement and the rate of PCR change from positive to negative will be evaluated in each group.
NCT04500067 Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment Recruiting Phase 3 2020-05-07 Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of several dangerous factors that consistently worsen the patient's condition: viral lung damage early in the disease; a sharp increase in inflammation on the background of an unbalanced immune response ("cytokine storm"); joining a bacterial infection. The condition of patients deteriorates significantly mostly at cytokine storm development. The damaging of a large volume of lung tissue leads to develops of respiratory failure, respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients die. There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous Administration (IVIG) high doses when used as part of complex therapy in patients with pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on survival rates, overall disease course, duration of stay in the intensive care unit, and ventilatory support duration. The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Multifocal motor neuropathy). This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe Pneumonia Caused by COVID-19 / SARS-CoV-2
NCT04501783 Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19 Active, not recruiting Phase 3 2020-05-20 Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
NCT04501796 A Trial of NT-I7 in COVID-19 (SPESELPIS) Recruiting Phase 1 2020-08-01 The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19): - Safety of a single dose of NT-I7 - The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.
NCT04502069 Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen Not yet recruiting Phase 1/Phase 2 2020-08-01 Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).
NCT04502667 Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19 Recruiting Phase 3 2020-07-15 Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin and Dimer D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning of hospitalization and on the 7th day after admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization.
NCT04504734 Bucillamine in Treatment of Patients With COVID-19 Not yet recruiting Phase 3 2020-08-30 This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 2:1 to the selected bucillamine dose or placebo The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 10 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
NCT04504877 Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19 Recruiting Phase 2/Phase 3 2020-06-16 The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.
NCT04505592 Tenecteplase in Patients With COVID-19 Not yet recruiting Phase 2 2020-08-01 This is a placebo-controlled, double blind, randomized, Phase II dose escalation study intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of COVID-19 associated respiratory failure. The hypothesis is that administration of the drug, in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.
NCT04505774 Anti-thrombotics for Adults Hospitalized With COVID-19 Not yet recruiting Phase 4 2020-08-01 This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients
NCT04508439 Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection Recruiting N/A 2020-06-20 Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL are associated with an 18-fold increased risk of mortality. In this context, many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins. Currently, there is no validated scheme on the dose and timing of the use of antithrombotic drugs. The study aims to identify the effect of two anticoagulant strategies (prophylactic and therapeutic) on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care.
NCT04509973 Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia Not yet recruiting Phase 3 2020-08-17 We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.
NCT04510038 Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury Not yet recruiting Phase 2/Phase 3 2020-09-01 Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.
NCT04510402 Phase I/II Trial of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects Not yet recruiting Phase 1/Phase 2 2020-08-01 Title: Phase I/II Trial (Safety and Dosing) of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects: Summary: This study will evaluate in a PH I/II trial in healthy volunteers the safety and tolerability of PVP-I nasal swabs daily application. The intent is to follow with a PH III randomized controlled clinical trial to assess the capacity for PVP-I nasal swabs to mitigate the transmission of respiratory viruses specifically COVID 19.
NCT04511819 Losmapimod Safety and Efficacy in COVID-19 Not yet recruiting Phase 3 2020-08-01 The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate COVID-19 disease.
NCT04512079 FREEDOM COVID Anticoagulation Strategy Randomized Trial Not yet recruiting Phase 4 2020-09-01 Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. (1) As the number of affected individuals continues to climb, effective strategies for treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed predominantly in the lungs but also throughout the cardiovascular system (2). Thus, while acute respiratory distress syndrome remains a feared complication, new thromboembolic disease has emerged as a common and potentially catastrophic manifestation of COVID-19.
NCT04513314 A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium Not yet recruiting Phase 4 2020-09-01 The primary purpose of this research is to determine whether Valproate alone, and in combination with Quetiapine, lowers confusion and agitation in persons with severe Corona Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator). Though Valproate and Quetiapine are often given to persons with severe confusion with agitation, the purpose of this small research study is specifically for: a) persons infected with COVID 2019 on a ventilator whose agitation is not responding to the usual medications (like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine, which requires continuous close monitoring in an ICU.
NCT04514302 Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody Fragments (INOSARS) for Hospitalized Patients With COVID-19 Not yet recruiting Phase 1/Phase 2 2020-10-20 This is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the treatment of hospitalized COVID-19 patients. Clinical improvement at 28 days from the start of treatment will be evaluated.
NCT04516759 AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19 Not yet recruiting Phase 2 2020-08-01 The ARCADIA Trial is a randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with either Type 1 or Type 2 diabetes, hospitalised with COVID-19.
NCT04516837 Eltrombopag Plus rhTPO Versus Eltrombopag for ITP During the COVID-19 Pandemic (ELABORATE-19) Not yet recruiting Phase 2 2020-08-01 This is a prospective, multicenter, randomized, open-label study to investigate the efficacy and safety of eltrombopag plus recombinant human thrombopoietin (rhTPO) versus eltrombopag as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) during the COVID-19 pandemic.
NCT04516915 IMU-838 and Oseltamivir in the Treatment of COVID-19 Recruiting Phase 2 2020-06-15 To evaluate whether time-to-improvement is significantly better in IMU-838 plus Oseltamivir (IONIC Intervention) and standard care vs. Oseltamivir and standard care in adult subjects with coronavirus disease (COVID-19)
NCT04519125 Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia Not yet recruiting Phase 2/Phase 3 2020-08-30 Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A Randomized Clinical Trial. This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers. The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, which is safe and is used as prophylaxis and treatment for HIV and other viral infections such as Hepatitis. Several laboratory-based studies indicate that this drug has the potential to inhibit SARS-CoV-2 replication. In addition, one study in HIV infected persons found that those taking Tenofovir /Emtricitabine tended to have a lower occurrence of COVID-19. In this study, we will compare the occurrence of infection with SARS-CoV-2/ COVID19 in health care workers between those assigned to an intervention group and those assigned to a control group. The intervention group will receive Tenofovir /Emtricitabine during 60 days in addition to the use of personal protective equipment (PPE), and the control group will receive a placebo during 60 days in addition to the use of personal protective equipment (PPE). The study will recruit 950 health professionals above 18 and less than 70 years, working in the emergency room, COVID wards and intensive care units of seven hospitals in Colombia. To make the comparison groups very similar, the participants will be assigned through a random mechanism to either the intervention (475), or the control (475) groups. In order to prevent biases in the evaluation of the results, neither the participants nor the clinical investigators, data managers, analysts and support personnel will know which intervention the participants are receiving. To determine the occurrence of infection with the virus the study will use both molecular tests that detect the presence of viral genes in respiratory secretions, and serological tests that detect the response of the immune system to the virus. The study will evaluate also the safety of this drug determining the occurrence of adverse events.
NCT04521400 the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19 Not yet recruiting Phase 2 2020-08-20 The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04523090 Catalysing the Containment of COVID-19 Not yet recruiting Phase 2/Phase 3 2020-08-19 COVID-19 due to SARS-CoV-2 infection is a rapidly escalating global pandemic for which there is no proven effective treatment. COVID-19 is multi-dimensional disease caused by viral cytopathic effects and host-mediated immunopathology. Therapeutic approaches should logically be based on interventions that have direct anti-viral effects and favourably modulate the host immune response. Thus, an optimal drug regimen in ambulatory patients should collectively (i) target and reduce viral replication, (ii) upregulate host innate immune anti-viral responses, (iii) have favourable immunomodulatory properties, and (iv) minimise disease progression to hospitalisation thus circumventing the 'cytokine storm' that likely underpins ARDS and multi-organ failure. Nitazoxanide (NTZ) is an antiprotozoal drug that is FDA-approved for treating Cryptosporidium and Giardia and has an excellent safety record for a variety of indications, but primarily as an anti-parasitic agent. It has proven broad anti-viral activity as it amplifies cytoplasmic RNA sensing, potently augments type I interferon and autophagy-mediated anti-viral responses, has immunomodulatory properties e.g inhibits macrophage IL-6 production, and interferes with SARS-CoV-2 glycosylation. It has been shown to have anti-viral activity against several viruses including Ebola, influenza, hepatitis B and C, rotavirus and norovirus. With regard to respiratory viral infections, NTZ was evaluated in uncomplicated influenza and demonstrated a reduction in the median time to symptom recovery. By contrast, NTZ failed to show benefit in hospitalised patients with severe influenza suggesting that, as with oseltamivir (Tamiflu), it likely needs to be administered early in the course of the disease. NTZ has proven in vitro activity against SARS-CoV-2. NTZ inhibited the SARs-CoV-2 at a low-micromolar concentrations and in vivo evaluation in patients with COVID-19 has been strongly recommended. NTZ has an excellent drug-drug interaction profile. No clinically significant interactions are expected with commonly used antihypertensive agents, antidiabetics drugs, antiretroviral agents, steroids or commonly prescribed analgesics / anti-inflammatory agents. We propose NTZ for the treatment of mild COVID-19 in non-hospitalised patients with HIV co-infection and/or enhanced risk for progression to severe disease (age > 50 years and/ or with comorbidity). We will perform a randomised controlled trial enrolling 960 patients with mild disease. The primary outcome measure will be the proportion progressing to severe disease (hospitalisation) based on the WHO clinical progression scale (progression to stage 4 and beyond). Secondary outcome measures will include disease rates in contacts and effect on viral load, productive infectiousness using viral cultures, and ability to abrogate the generation of infectious aerosols using novel cough aerosol sampling technology. Recruitment is stratified and thus the study is powered to detect progression to severe disease in HIV-infected persons.
NCT04523181 A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients With Mild to Moderate Pneumonia Due to COVID-19 Not yet recruiting Phase 2 2020-09-07 To evaluate the safety andefficacy of antroquinonol treatment of mild to moderate pneumonia due to COVID-19, as measured by the proportion of patients alive and free of respiratory failure.
NCT04523831 Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection Recruiting Phase 3 2020-06-01 On 31 December 2019, the World Health Organization (WHO) was formally notified about a cluster of cases of pneumonia in Wuhan City, China. On 7 January the responsible virus was isolated and its genome sequence was shared on 12 January. It was named as COVID-19, a novel Coronavirus, SARS-CoV-2. It is a member of the Corona virus family which is RNA enveloped viruses. Very rapidly the virus emerged as pandemic. Now it is dominating the lives of every people of this universe. Management of the COVID-19 relies on mainly supportive care and oxygen supplementation via non-invasive or mechanical ventilation in critical cases. Patients who are critically ill may also require vasopressor support and antibiotics for secondary bacterial infections. There is no vaccine or highly effective antiviral drugs for COVID-19. Currently there is a tremendous effort around the world to develop effective preventive and therapeutic treatment for this disease. World Health Organization has launched a non-blinded clinical trial (SOLIDARITY) to evaluate four candidate treatments (remdesivir, lopinavir/ritonavir, lopinavir/ritonavir/ interferon beta-1a, and chloroquine or hydroxychloroquine) versus standard of care in 18 countries worldwide. RECOVERY trial one of the largest trials to see the efficacy and safety of hydroxychloroquine revealed that they are no clear cut clinical benefit for COVID-19. Other drugs in the SOLIDARTY trial are quite expansive for resource limited countries like Bangladesh. Study Published in the American Journal of Tropical Medicine advocates further research into Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was brought by Australian researchers from Monash University who demonstrated its efficacy against the SARS-CoV-2 coronavirus in vitro studies. In different study Doxycycline also showed promising results in treatment of COVID 19 infection. It is highly lipophilic antibiotics that are known to chelate zinc component of matrix metalloprotienases (MMP). Corona viruses are known to rely heavily of MMPs for survival, cell infiltration and replication. It also has an anti-inflammatory effect which might be effective in combating cytokine storm of Covid-19 infection. So it have been planned to conduct an experimental clinical trial using combination of ivermectin and doxycycline for treatment of COVID 19 along with the other standard care.
NCT04525820 High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study Not yet recruiting N/A 2020-09-01 The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.
NCT04527211 Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Not yet recruiting Phase 3 2020-09-07 It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the effectiveness and safety of the administration to of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.
NCT04527354 Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia Not yet recruiting Phase 2 2020-08-01 The innovative drug Treamid is planned for use in the rehabilitation of patients after COVID-19 pneumonia in a pilot, multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to assess the efficacy and safety of Treamid, tablets, 50 mg in patients with fibrotic changes in the lungs after COVID-19 pneumonia during a 28-day treatment. The primary objective of the study is to demonstrate the efficacy of Treamid tablet, 50 mg in change in forced vital capacity (FVC) and/or diffusing capacity of lung for carbon monoxide (DLCO) at Week 4. The secondary objective of the study is to evaluate the safety of Treamid tablet, 50 mg and pharmacokinetics (PK).
NCT04528667 Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19 Not yet recruiting Phase 2 2020-09-01 A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19
NCT04528888 Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection Not yet recruiting Phase 3 2020-09-01 SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.
NCT04529499 Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients Recruiting Phase 3 2020-08-20 This is a prospective, interventional, multi-centre, phase III, randomized, double blind, placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2 and presenting with moderate to severe COVID-19. This study will be conducted in two parts; Stage I - Main study and Stage II - Extended Follow up.
NCT04530617 Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients Not yet recruiting Phase 2 2020-08-01 This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies (camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others.
NCT04531748 Selective Estrogen Modulation and Melatonin in Early COVID-19 Not yet recruiting Phase 2 2020-09-01 This study is a randomized, double-blind, controlled clinical trial to evaluate the effects of toremifene and/or melatonin in adults with mild COVID-19.
NCT04532372 Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy Not yet recruiting Phase 1/Phase 2 2020-09-18 This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.
NCT04532554 Growth Hormone in Obese Cases With Covid-19 Not yet recruiting Phase 4 2020-08-26 The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.
NCT04533347 A Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of Oral Tafenoquine Versus Placebo in Patients With Mild to Moderate COVID-19 Disease Not yet recruiting Phase 2 2020-10-01 A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease.
NCT04534478 Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Not yet recruiting Phase 4 2020-09-07 Background: Based on data from the 2003 SARS-COVID pandemic, other serious lung infections, and patients with respiratory distress, it is estimated that 10-30% of patients with severe SARS-COVID-2 pneumonia may present as a sequel an organized pneumonia. The treatment of this complication is not well defined. The use of oral corticosteroids is mandatory to avoid a possible evolution to pulmonary fibrosis, however, the doses to be administered and the duration of treatment are unknown as there is no study specifically aimed at solving this doubt. Many authors advocate high-dose treatment regimens for a minimum of six months, as proposed for cryptogenic organized pneumonia. However, there is a question whether in non-idiopathic cases of organized pneumonia, less intense treatment could resolve the disease. Hypothesis: The use of a less intensive prednisone regimen may be sufficient for therapeutic control in patients with post-COVID-19 organizing pneumonia, in relation to the established standard regimen Simplicity of the procedures: The objective of the NORCOVID study is to identify the optimal treatment regimen with corticosteroids in post-COVID19 patients diagnosed with NO. Specifically, the primary objective of this multicenter randomized trial is to evaluate whether treatment with a less intensive regimen of corticosteroids produces a non-inferior therapeutic effect than the established control regimen. Secondary objectives are to evaluate the effect of treatment on secondary efficacy variables and on safety. DLCO, respiratory function tests, 6MWT test, need for rescue, radiological tests, complications, mortality and the WHO ordinal scale will be evaluated.
NCT04534673 Pegylated Interferon Lambda for Treatment of COVID-19 Infection Recruiting Phase 2 2020-08-05 A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously once weekly, for up to two weeks (2 injections at most), in addition to standard supportive care, compared to standard supportive care alone, in a population of COVID-19 infected patients. patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg S.C + standard care (intervention arm) or standard care only (control arm).
NCT04534803 BCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST) Not yet recruiting Phase 3 2020-09-01 The purpose of this study is to assess the efficacy of Bacille Calmette-Guérin (BCG) vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities. The investigators hypothesize that BCG vaccination can reduce severity of Covid-19 disease. Patients who are residents of participating long-term care facilities (LTCFs), with the ability to understand and cooperate with study procedures, who agree to participate in the study will be randomly assigned to receive BCG vaccination or a placebo. Participants will be followed for up to twelve months to assess severity of Covid-19 outcomes.
NCT04535700 Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19 Not yet recruiting Phase 4 2020-09-07 The treatment with pioglitazone added to the standard treatment of patients with DM2 hospitalized for COVID-19 may produce a decrease in the number of patients who progress to a second phase of severe systemic inflammation.
NCT04535791 Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers Recruiting Phase 3 2020-07-15 In a blinded randomized clinical trial, which will include health workers (doctors, residents, nurses, stretcher-bearers, technicians, hygiene and cleaning) who are members of the health teams that care for patients with COVID-19. Two groups will be formed: the Vitamin D group taking 4,000 IU orally daily for 30 days, the control group being given a placebo during the same time period. Participants will be adults, who have not had COVID-19 disease, and who sign the informed consent. At the beginning of the study anthropometric variables (weight, height, BMI) will be taken, the short medical history can be identified to identify comorbidities, and a fasting blood sample will be taken to determine changes in Vitamin D (25 (OH) Vitamin D), in addition to RT-PCR saliva samples, as well as detection of serum antibodies to determine whether or not they have SARS-CoV-2 disease. Participants will follow each other 45 days. Those with COVID-19 disease will be monitored frequently to determine the course of the disease. At the end of 45 days, new samples will be taken to determine levels of vitamin D and antibodies against SARS-Cov-2.
NCT04535856 Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients Not yet recruiting Phase 1 2020-09-11 This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1 x 10^8cells for the high-dose group after registration. Subjects assigned to the control group were administered with placebo in the same manner as the test drug (DW-MSC). At this time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to standard therapy. This clinical trial is a double-blind trial, in which a randomized method will be used. To maintain the double-blindness of the study, statistician who do not participate in this study independently generate randomization code. Subjects will be randomized to the test groups (low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio. After the completion of the trial, the randomization code will be disclosed after unlocking the database and unblinding procedures. Follow Up period: observed for 28 days after a single administration
NCT04535869 Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) Not yet recruiting Phase 3 2020-09-04 COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed to have a high potential for transmission to close contacts on 20 January 2020 by the National Health Commission of China and it was announced as a pandemic by the WHO on 11 March 2020. There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy. Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based on the similarity between the replication mechanisms of the HCV and the coronaviruses. Aim of our study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients according to MOHP protocol.
NCT04536090 Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of COVID-19 Not yet recruiting Phase 2 2020-11-01 This is an open-label, randomized, multi-centre pilot study where hospitalized subjects will be randomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard of care or standard of care only for 28 days following confirmation of a COVID-19 infection.
NCT04536350 Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS Not yet recruiting Phase 1 2020-09-01 The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.
NCT04536363 Cri Analog PG1 Effectiveness and Safety in Covid-19 Not yet recruiting Phase 2 2020-10-01 The Clinical trial aim to evaluate the effectiveness and safety of the administration of the intravenous prostaglandin E1 analog in the reduction of mortality and complications of patients with COVID-19 diagnosis. Therefore the investigators propose an open randomized clinical trial in the Fundación Santa Fe de Bogota
NCT04537585 COVID-19: Collecting Measurements of Renin-angiotensin-system Markers, Such as Angiotensin-2 and Angiotensin 1-7 Not yet recruiting N/A 2020-11-01 Investigators study meet the World Health Organization definition of a clinical trial because it is a prospective study in which participants will be assigned to intervention groups to investigate the effects on health outcomes. Investigators highlighted clearly the real problem that indigeneous patients are facing now in the Democratic Republic of the Congo: Poverty meaning the lack of money to buy goods and drugs. From the news report, investigators learned that "In the Democratic Republic of the Congo, indigenous communities in Kananga, Tshikapa and in the Kasai region are increasing their consumption of "Vernonia amygdalina," a traditional plant believed to cure several diseases, including alleviating COVID-19." Based on an unpublished work, quite a few extract molecules of Vernonia amygdalina are excellent antiviral candidates which are the family members of Remdesivir in terms of their antiviral mechanisms. Furthermore, the antiviral capabilities of these molecules are significantly stronger than or at least equivalent to Remdesivir. The target zones of these molecules in the human body cover a set of important organs and tissues. For example, Vernolide (C19H22O7) is able to reside firmly at bronchi, the upper respiratory tract, and blood vessels. From the news report, investigators learned also that Herbs used in Tanzania include lemon, ginger, neem tree leaves, mango tree leaves, orange tree leaves. These traditional medicines contain, more or less, antiviral molecules whose capacities range from good to outstanding levels. Those herbs have been used worldwide to fight COVID-19. In conclusion traditional medicines have been playing important roles not only in Africa but also in Asia, in South America, etc. Herbs prove themselves with effective efficacies in many therapeutic practices. So maybe after careful considerations, the World Health Organization may support the use of herbs for poor patients who cannot afford modern drugs and used traditional medicines after a positive COVID-19 test in the Democratic Republic of the Congo. Investigators are talking about a randomisation's nuance process to follow participants who decide by themselves if diagnosed positive to COVID-19 to begin to take herbs not waiting for a physician prescription.
NCT04539275 COVID-19 (VA CURES-1) Not yet recruiting Phase 3 2020-09-21 The purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19.
NCT04539626 Estrogen Therapy in Non-severe COVID-19 Patients Not yet recruiting N/A 2020-10-01 The primary objective of this study is to evaluate the effect of additional estradiol estrogen therapy on clinical response and mortality in non-severe COVID-19 patients
NCT04539873 Impact of Colchicine in Hospitalized Colombian Patients With COVID-19 Not yet recruiting Phase 3 2020-09-01 This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days
NCT04540120 Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome Not yet recruiting Phase 2 2020-09-01 The purpose of this study is to assess the safety and efficacy of orally-administered dapansutrile capsules for the treatment of moderate COVID-19 symptoms and evidence of early cytokine release syndrome.
NCT04541979 Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19 Recruiting Phase 2 2020-06-04 Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.
NCT04542408 Hamburg Edoxaban for Anticoagulation in COVID-19 Study Not yet recruiting Phase 3 2020-09-01 Hero-19 aims to evaluate if an intensive anticoagulation strategy using Edoxaban on top of standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin [LMWH], ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality endpoints in patients with COVID-19.
NCT04542694 Open-label Randomized Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19 Completed Phase 3 2020-05-21 This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.
NCT04549376 Virucidal Effect of Povidone Iodine on COVID-19 In-Vivo Recruiting Phase 2 2020-07-01 It is an established fact that, corona virus spread through the respiratory droplets. Colonization of the virus in oropharynx and/or nasopharynx is considered to be major factor for transmissibility of the virus through respiratory secretions. Preventing colonization of the virus by administrating povidone iodine in the nasal passage therefore, a rational thought which is supported by recent evidence of in-vitro virucidal action of povidone iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2). Therefore, the study is designed to assess the virucidal effect of povidone iodine on COVID-19 virus in-vivo.This open label randomized clinical trial will be conducted at Department of Otorhinolaryngology and Head Neck Surgery, in collaboration with Department of Virology and Department of Medicine in Dhaka Medical College (DMC) Hospital. The study will be conducted from September 2020 to October 2020. Total 175 confirmed cases of COVID-19 disease, proven by Reverse transcription polymerase chain reaction (RT-PCR) testing will be enrolled in this study. Written informed consent will be ensured before participation. In case of no literacy, finger print will be considered for written permission.Consent will be sought from the legal guardian in case of minor or underaged.Formal ethical clearance will be taken from Ethical Review Committee (ERC) of Dhaka Medical College. All of the Participants will be divided into seven groups: Group A will receive Povidone iodine (PVP-I) nasal irrigation at concentration of 0.4%, Group B and Group C will received 0.5% and 0.6%; Group D will receive PVP-I nasal spray at concentration of 0.5% and Group E will received at 0.6% concentration. Group F (Placebo comparator group) will receive nasal irrigation by distilled water (DW) and Group G (Placebo comparator group) will received nasal spray by distilled water. The contact time will be minimum 30 seconds. After the individual application of PVP-I and distilled water in respective participant, they will be tested again for RT-PCR for COVID-19 from nasopharyngeal and oropharyngeal sample. All patients will be subjected to detail history, physical examination and adverse events. Block Randomization will be followed for randomization. Data will be recorded in a semi-structured questionnaire and will be analyzed by 'R-4.0.2' data analysis software
NCT04549922 Antisense Therapy to Block the Kallikrein-kinin Pathway in COVID-19 Not yet recruiting Phase 2 2020-10-01 Up to 1/3 of all patients infected with COVID-19 can develop complications that require hospitalization. Severe pneumonia associated with acute respiratory distress syndrome (ARDS) is the most threatening and feared complication of COVID-19 infection, with mortality rates close to 50% in some groups. Autopsies between these severe cases reveal severe capillary involvement, with signs of intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal tissue repair. The available evidence suggests that abnormal activation or imbalance in the counter-regulation of the kallikrein-kinin system may play a central role in a positive feedback cycle, leading to consequent diffuse microangiopathy. Blockade of the kallikrein-kinin system can therefore prevent deterioration of lung function by reducing inflammation, edema and microthrombosis. The objective of this phase IIb study is to assess the preliminary effects on the oxygenation parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients with moderate to severe COVID-19.
NCT04550338 Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure Not yet recruiting Phase 3 2020-12-01 A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection.
NCT04551755 Safety and Efficacy of Ivermectin and Doxycycline in Treatment of Covid-19 Not yet recruiting Phase 2 2020-09-01 A randomized double blind control trial will be done. Total 188 Covid-19 patients will be enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base line investigations will be done and as per eligibility criteria 188 (one hundred eighty eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed patients (Group-B) will be in the control group. Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with standard therapy and Group -B will be treated by standard therapy with placebo. Follow up will be done every day in both group with all the parameters as stated above and will be documented. On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done and also on 11th day subject to test result as negative on 10th day. Death of the patients will be documented as well. Regarding safety issues of the drugs we shall monitor for any SAE and would report to the DSMB for proper management guideline
NCT04552483 Effects of Early Use of Nitazoxanide in Patients With COVID-19 Completed Phase 2 2020-06-08 Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
NCT04558021 A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19 Recruiting Phase 3 2020-09-28 This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients. The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo. The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.
NCT04558125 Low-Dose Tenecteplase in Covid-19 Active, not recruiting Phase 4 2020-09-08 - There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. - These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. - When DIC is associated with COVID-19, it predicts a very poor prognosis. - We plan to evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. We believe that acute PE in the setting of active COVID-19 infections likely portend a poor prognosis. - Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. - We hope to generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients.
NCT04558463 The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19 Recruiting Phase 3 2020-04-16 This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
NCT04559074 Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic Not yet recruiting Phase 4 2020-09-30 This trial is focusing on blood pressure control for patients with high blood pressure (hypertension) during the COVID-19 pandemic when seeing a doctor for advice may be difficult. The study utilises remote consultations by telephone or video conferencing. Patients record blood pressure and data into an electronic diary on their phone which is reviewed in consultations every 2 weeks by a clinician. Medication for this trial is amlodipine as an oral solution which is uptitrated accordingly for patients receiving medication (anticipated 200). 800 patients will be in an observational group recording the same readings and will not receive any medication.
NCT04559113 Methylprednisolone in COVID-19 Patients (Methyl19LGH) Recruiting N/A 2020-05-01 In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS. Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials
NCT04560205 Tocilizumab in COVID-19 Lahore General Hospital Recruiting Phase 1 2020-05-01 The most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.
NCT04561063 COVID-19 Prophylaxis South Africa (COVER HCW) Not yet recruiting Phase 2 2020-12-01 This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.
NCT04561219 Nitazoxanide Therapy for Patients With COVID 19 Pneumonia Active, not recruiting Phase 2 2020-04-19 Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
NCT04567173 Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19 Recruiting Phase 2/Phase 3 2020-09-21 This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.
NCT04568863 Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19 Recruiting Phase 2 2020-06-20 There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.
NCT04569825 Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease Recruiting Early Phase 1 2020-08-01 Background: Anosmia is a debilitating common symptom of COVID-19. The therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. However, the effect of local steroid was not assessed before. Objective: To estimate the efficacy of local steroid in the treatment of anosmia in COVID-19 patients.
NCT04569877 GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia Recruiting Phase 2 2020-09-24 To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.
NCT04570384 Intravenous L-Citrulline to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19 (SARS-CoV-2) Illness Not yet recruiting Phase 2 2020-09-28 Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous L-Citrulline to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2) Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection (SARS-CoV-2).
NCT04570397 Ravulizumab and COVID-19 Not yet recruiting Phase 3 2020-11-01 Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminal complement products and is proposed for the treatment of COVID-19 induced microvasculature injury and endothelial damage leading to thrombotic microangiopathy (TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants with a confirmed diagnosis of COVID-19 who clinically or diagnostically present with deteriorating renal function. Ravulizumab causes immediate and sustained inhibition of the terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 induced kidney injury due to TMA, shorten hospital stay, and improve the overall survival.
NCT04573153 Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients Recruiting Phase 2/Phase 3 2020-09-21 This open label, randomized, controlled, investigator-initiated, multi-centre trial aims to establish metabolic improvements in COVID-19 subjects by dietary supplementation with cofactors N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside and serine plus standard therapy. The primary objective is to assess the clinical efficacy of the combination of metabolic cofactors supplementation and hydroxychloroquine in COVID-19 patients.
NCT04575558 HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19 Withdrawn Phase 2 2020-06-30 Multicenter, double blind, randomized clinical trial for high-risk patients over 18 years of age, symptomatic for COVID-19 infection, without any severity criteria
NCT04575610 IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC) Not yet recruiting Phase 2 2020-10-10 The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19.
NCT04576312 Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19 Recruiting Phase 1 2020-06-29 This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19
NCT04576728 Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 Not yet recruiting Phase 2 2020-10-01 The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19. Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.
NCT04578236 Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2) Not yet recruiting Phase 2 2020-11-01 Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 20,000,000 people causing over 700,000 deaths. It has no currently approved treatments.Airborne SARS-CoV-2 infections in humans initiate from the virus entering nasal and airway epithelial cells through binding to angiotensin-converting enzyme 2 (ACE2). Transmembrane protease, serine 2 (TMPRSS2), a cellular protease that activates the SARS-CoV-2 spike protein, colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane. Transmembrane protease, serine 2 (TMPRSS2) is an androgen receptor signaling target gene and an androgen-regulated cell-surface serine protease expressed predominantly in prostate and lung epithelial cell. TMPRSS2 is normally expressed several folds higher in the prostate relative to any other human tissue, though the normal physiological function(s) remains unknown. A study found that dihydrotestosterone (DHT) s a potent activator of TMPRSS2.On the other hand, Feily et al noted that low-dose isotretinoin (0.5 mg/kg/day for 15-20 weeks) in PCO patients with moderate to severe nodulocystic acne resulted in significant decreases in levels of serum total testosterone, prolactin, and dihydrotestosterone A study demonstrated that 13- cis -Retinoic acid competitively and reversibly inhibits dihydrotestosterone. Therefore, we suggest that 13- cis -Retinoic acid will downregulate TMPRSS2 expression thorough temporary preventing the effect of dihydrotestosterone (DHT) on the activation of TMPRSS2 gene expression. ACE inhibitors and ARBs are commonly taken by heart patients to reduce blood pressure and to treat heart failure.Earlier studies had cautioned that this class of drugs could possibly increase the risk for the novel coronavirus, SARS-CoV-2, infection and elevate COVID-19 severity. There is conflicting observational evidence about the potential clinical impact of ACE inhibitors and ARBs on patients with COVID-19. Select preclinical investigations have raised concerns about their safety in patients with COVID-19. On the other hand, Preliminary data hypothesise that angiotensin-converting enzyme (ACE) inhibitors and renin-angiotensin- aldosterone system (RAAS) inhibitors could benefit patients with COVID-19 by decreasing acute lung damage and preventing angiotensin-II-mediated pulmonary inflammation. Here in our review, we use established and emerging evidence based on the findings of previous studies and researches to propose that ACE inhibitors may benefit patients with COVID-19 via attenuating and abolishing the effect of androgenic hormones on inducing the expression of Transmembrane protease, serine 2 (TMPRSS2), even though, at the same time, ACE inhibitors cause an increase in the human cell surface receptor protein ACE2 which the novel coronavirus uses to enter and infect cells. A study on hypertensive rats demonstrated that using ACE inhibitors(captopril) abolished and attenuated the effect of dihydrotestosterone (DHT). In this study RAS inhibition exhibited beneficial effects on androgen-induced obesity and abolished the androgen-mediated increase in blood pressure (BP) observed in this model of PCOS. (83 ± 1 vs 115 ± 3 mmHg, p<0.0001). A another study found that the angiotensin converting enzyme inhibitor captopril abolished testosterone effect and attenuates testosterone-induced benign prostatic hyperplasia in rats; a mechanistic approach. Captopril is a potent inhibitor of the angiotensin converting enzyme. These effects of testosterone were almost prevented by captopril (100 mg/kg). In conclusion, generally treatment with ACE inhibitors is associated with reduced androgen levels. Therefore,we think that Transmembrane protease, serine 2 (TMPRSS2) is an indirect target of ACE inhibitors and 13 cis retinoic acid As aresult, we hypothesize that any drug which downregulates TMPRSS2 expression through targeting AR, AR co-regulatory factors, or AR downstream transcription factors might be potentially effective against COVID-19 and is worth investigating under a clinical trial.. Keywords: COVID -19, Transmembrane protease, serine 2 (TMPRSS2), ACE inhibitors, ACE2.
NCT04579393 Fostamatinib for Hospitalized Adults With COVID-19 Recruiting Phase 2 2020-10-12 Background: COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19. Objective: To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes. Eligibility: Adults age 18 and older who are hospitalized with COVID-19. Design: Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed. Participants will be randomly assigned (like the flip of a coin), to take either fostamatinib pills or a placebo (sugar pill) twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit. Participation will last for about two months
NCT04581954 Inflammatory Signal Inhibitors for COVID-19 (MATIS) Recruiting Phase 1/Phase 2 2020-10-02 The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.
NCT04582201 An Experiment to Evaluate the Safety of agenT-797 in COVID-19 Patients With Severe Difficulty Breathing. Recruiting Phase 1 2020-09-21 A Phase 1 Study of AGENT-797 to treat moderate to severe acute respiratory syndrome in COVID-19 patients.
NCT04583956 Big Effect Trial (BET-A) for the Treatment of COVID-19 Not yet recruiting Phase 2 2020-10-30 This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 40 sites throughout the US. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 100 subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-A stage will evaluate the combination of remdesivir with risankizumab vs remdesivir with a risankizumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
NCT04583969 Big Effect Trial (BET-B) for the Treatment of COVID-19 Not yet recruiting Phase 2 2020-10-30 This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 40 sites throughout the US. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 100 subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
NCT04584684 Mouth Rinses for Inactivation of COVID-19 Not yet recruiting Phase 2 2020-10-01 Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.
NCT04584697 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 Not yet recruiting Phase 1/Phase 2 2020-12-01 This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.
NCT04584710 A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults Not yet recruiting Phase 2 2020-10-01 The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial.
NCT04586153 Study to Assess the Effect of Meplazumab on COVID-19 Not yet recruiting Phase 2/Phase 3 2020-10-30 This phase2/3 study will be conducted to evaluate the safety and efficacy of Meplazumab in addition to Standard of Care for the treatment of Corona Virus Disease(COVID) 19 in hospitalized adults
NCT04588792 Furosemide as Supportive Therapy for COVID-19 Respiratory Failure Not yet recruiting Phase 2/Phase 3 2020-10-19 This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19.
NCT04591600 Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients Completed Phase 1/Phase 2 2020-07-01 A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .
NCT04593940 Immune Modulators for Treating COVID-19 Not yet recruiting Phase 2 2020-10-01 ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.
NCT04594330 Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients Recruiting Phase 2 2020-06-01 Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.
NCT04594343 A Randomized, Double-blind, Placebo-controlled Safety and Clinical Outcomes Study of Disulfiram in Subjects With Moderate COVID-19 Not yet recruiting Phase 2 2020-10-01 This clinical trial evaluates the safety, efficacy, and biomarker levels of FDA-approved drug disulfiram in the treatment of adult subjects hospitalized with moderate COVID-19. Disulfiram may limit the hyperinflammatory response associated with COVID-19 and reduce the risk of progression to severe illness. Subjects will be screened and randomized to receive either daily administration of oral disulfiram or placebo for 14 days. Subjects will be followed up on Day 28.
NCT04597775 Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis Not yet recruiting Phase 2/Phase 3 2020-10-27 Protocol summary Title A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label, chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19 Study Periods & Duration of Treatment Study Duration: 6 months Approval (IRB and regulatory bodies) 1 month Recruitment and follow-up: 3 months Analysis, report writing and submission of publications 1 month This study is a parallel study of one period with an expected duration of treatment (for each subject) of 28 days, Objectives - To evaluate if hydroxychloroquine with the proposed dose can provide potent chemoprophylaxis against the development of COVID-19 positive patients in subjects who had primary exposure to COVID-19 positive patients. - To measure the incidence of potential adverse drug reaction rates for giving hydroxychloroquine for prevention of COVID-19 amongst close contacts - To provide early analysis of results and redefine sample size accordingly. - identifying subjects most likely to benefit during the phase II and focusing recruitment efforts on them during phase III - stopping one arm or the whole trial at an early stage for success or lack of efficacy based on phase II study results Design Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following: Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5. Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5. Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.
NCT04602442 Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia Enrolling by invitation Phase 2 2020-10-01 Coronavirus is an acute viral disease with prevailing upper respiratory tract infections caused by the RNA-containing virus of the genus Betacoronavirus of the Coronaviridae family. Most patients with severe COVID-19 develop pneumonia in the first week of the disease. As the infection progresses, the infiltration increases, and the affected areas increases. Excessive and uncontrolled immune system response with rapidly developing fatal cytokine storm plays the main role in the pathogenesis of acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 infection. According to available data, exosomes can regulate inflammation and regenerative processes due to the change in the concentration of anti-inflammatory cytokines and switch the immune cell to regenerative secretome. Inhalation of exosomes may reduce inflammation and damage to the lung tissue and stimulate the regenerative processes. This protocol has been developed based on the literature, information about the ongoing tests NCT04276987 (A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia) and NCT04384445 (Organicell Flow for Patients With COVID-19), Patent No 271036826 of 2019. "A method for obtaining and concentrating microRNA-containing exosomal multi-potent mesenchymal-stromal cells for use in cosmetic and pharmaceutical products to stimulate regenerative processes and slow down aging.
NCT04603690 Study to Investigate the Benefits of Colchicine in Patients With COVID-19 Not yet recruiting Phase 3 2020-11-15 COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. We present a randomized, controlled, open-labeled, and pragmatic clinical trial to study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but no intensive care yet. Colchicine will be started within the first 48 hours and continue for 14 days using a descending dose. The benefits will be studied in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is affordable and widely accessible which would help to prevent the inflammatory complications associated with COVID-19.
NCT04603729 Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease Completed Phase 3 2020-05-30 The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.
NCT04603794 Efficacy of Mouthwash in Reducing Salivary Carriage of COVID-19 Recruiting Phase 4 2020-10-01 Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.
NCT04603924 Study of Niclosamide in Moderate Hospitalized Coronavirus-19 (COVID-19) Patients Recruiting Phase 2/Phase 3 2020-10-07 Study of ANA001 in Moderate COVID-19 Patients
NCT04604223 Effect of Pioglitazone on T2DM Patients With COVID-19 Not yet recruiting Phase 4 2020-11-15 Approximately 10-15% of patients infected with COVID-19 develop severe illness characterized by respiratory distress, increased risk of clotting disease, myocardial damage, stroke and mortality. Subjects with Type 2 diabetes (T2DM) are at increased risk for severe COVID-19 disease. Exuberant inflammatory and immune responses were suggested as the etiology responsible for the development of severe COVID-19 disease. The increased chronic inflammatory state characteristic of T2DM could contribute to the increased risk of severe COVID-19 disease in T2DM patients. Therefore, its possible that anti-inflammatory therapy will reduce the risk of severe COVID-19 disease. Consistent with this assumption, a recent study has reported that steroid therapy improves the outcome in patients with severe COVID-19 disease. The medication pioglitazone is a strong insulin sensitizer that reduces plasma glucose concentrations in T2DM patients. In addition to improving insulin sensitivity, several studies have demonstrated that pioglitazone reduces chronic inflammation in T2DM patients, which is manifested in a decrease in TNF-alpha, interleukin, hs CRP, leptin and other inflammatory markers in T2DM treated with pioglitazone. Further, pioglitazone enhances the plasma level of anti-inflammatory agents. For example, the plasma level of 15-epi-lipoxin A, a lipid mediator with strong anti-inflammatory and inflammation-resolving effects that has been reported to neutralize RNA coated viruses, is significantly elevated by pioglitazone treatment in T2DM patients. Therefore, we hypothesize that administering pioglitazone to T2DM patients who have moderate-to-severe COVID-19 will improve the clinical outcome of their COVID-19 disease.
NCT04604678 Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19 Not yet recruiting Phase 2 2020-11-01 Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
NCT04604704 Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome Not yet recruiting Phase 2 2020-11-01 Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.
NCT04606069 Treat COVID-19 Patients With Regadenoson Not yet recruiting Phase 1/Phase 2 2020-11-01 More than 17 million people have been infected and more than 677K lives have been lost since the COVID-19 pandemic. Unfortunately, there is neither an effective treatment nor is there a vaccination for this deadly virus. The moderate to severe COVID-19 patients suffer acute lung injury and need oxygen therapy, and even ventilators, to help them breathe. When a person gets a viral infection, certain body cells (inflammatory/immune cells) get activated and release a wide range of small molecules, also known as cytokines, to help combat the virus. But it is possible for the body to overreact to the virus and release an overabundance of cytokines, forming what is known as a "cytokine storm". When a cytokine storm is formed, these cytokines cause more damage to their own cells than to the invading COVID-19 that they're trying to fight. Recently, doctors and research scientists are becoming increasingly convinced that, in some cases, this is likely what is happening in the moderate to severe COVID-19 patients. The cytokine storm may be contributing to respiratory failure, which is the leading cause of mortality for severe COVID-19 patients. Therefore, being able to control the formation of cytokine storms will also help alleviate the symptoms and aid in the recovery of severe COVID-19 patients.
NCT04606563 Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan on Outcomes of Coronavirus Infection? Recruiting Phase 3 2020-10-09 SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that we call "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response. ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARB, losartan, limits lung injury in murine influenza H7N9 and decreases viral titre and RNA. We have a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARB, losartan) to decrease the mortality of hospitalized COVID-19 patient.
NCT04610138 Randomized, Double-Blind, Placebo-Controlled Study of ZnAg to Treat COVID-19 Symptomatic Participants Not yet recruiting Phase 2 2020-12-01 This is a multi-site, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of ZnAg liquid solution in symptomatic participants with acute COVID-19 that are not hospitalized at the time of enrollment.
NCT04611256 Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 Recruiting Phase 1 2020-08-01 The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.
NCT04611425 REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19, the REHSCU Study Not yet recruiting Phase 2 2020-11-01 The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.
NCT04615871 Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 Not yet recruiting Phase 2 2020-11-30 With the results of this study the investigators aim to identify an effective treatment that will reduce morbidity and mortality of patients with symptomatic COVID-19 infection, which would in turn reduce the burden on the healthcare system by decreasing the need for intensive care. Objectives: The main objective of this research is to determine if once weekly treatment with the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiac complications of COVID-19 infection. Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced risk profile as described above, who have been admitted to hospital due to symptoms of COVID-19 infection but do not as yet require critical care will be approached to participate in this study. Provided there are no exclusion criteria and the participants agree by means of documented written informed consent, The participants the participantswill be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately after randomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn at Day 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG will be obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28. Primary outcome measure: A composite of (1) death from any cause or (2) mechanical ventilation (invasive or non-invasive) at 28 days. Major secondary outcome measure: (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at Day 7±2 days and Day 14±2 days post randomization. Other major secondary outcome measure: A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.
NCT04615949 CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors Not yet recruiting Phase 2/Phase 3 2020-12-01 Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.
NCT04619680 The Study Will Evaluate the Use of Nintedanib in Slowing Lung Fibrosis in Patients With Pulmonary Infiltrates Related to COVID Recruiting Phase 4 2020-11-01 This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.
NCT04621149 An Outpatient Study Investigating Non-prescription Treatments for COVID-19 Not yet recruiting Phase 2 2020-11-09 This is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for COVID-19.
NCT04621461 Hydroxychloroquine, Azithromycin and Zinc for the Treatment of COVID-19 in the Outpatient Setting Not yet recruiting Phase 4 2020-11-01 This is a randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of hydroxychloroquine, azithromycin and zinc in a higher risk COVID-19 positive outpatient population.
NCT04622865 Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19 Recruiting Phase 2 2020-06-01 Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.
NCT04622891 Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection Completed N/A 2020-04-01 The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough
NCT04623385 Clinical Role of Testosterone and Dihydrotestosterone and Which of Them Should be Inhibited in COVID-19 Patients - A Double-edged Sword? Not yet recruiting Phase 4 2020-11-01 Clinical Role of Testosterone and Dihydrotestosterone and which of them should be inhibited in COVID-19 patients - A double-edged sword? COVID-19 attacks and affects Males significantly more than females [1], [2]. Males with COVID-19 are reported to die at twice the rate of females when they come infected with the virus [3]. The upregulation of TMPRSS2 by androgens could explain the increased susceptibility to COVID-19 in men.Contrary to expected, as a study demonstrated that The expression level of TMPRSS2 increased 6-fold in androgen stimulated LNCaP cells, relative to androgen-deprived cells[4]. But, surprisingly, low levels of testosterone led to the over expression and upregulation of ACE2 and TMPRSS2 receptors, facilitating SARS-CoV-1 entry into the alveolar cells, and deregulating a lung-protective pathway [5].According to literature Dihydrotestosterone is many times more potent than testosterone, and many of the effects that testosterone has in the body only happen after it is converted to dihydrotestosterone [6]. Therefore, we hypothesis that testosterone has better effect than dihydrotestosterone in case of COVID-19, because a study found that DHT significantly induced the expression of TMPRSS2 [7]. And at the same time , decreased testosterone levels in critically diseased males harmfully affect pulmonary endothelial cell functioning, impair the ability to clear the virus , promote systemic . Obesity among males, promote defective immune response, , and also generates more pro-inflammatory cytokines important in cell signaling, emanating in increased, severe disease, worst outcome and vulnerability. Insufficient serum testosterone level is a poor prognostic indicator for patients infected with COVID-19 by downregulation pulmonary protective pathways [5], [8]. On the contrary, high testosterone levels can lead to complication of thrombosis which is also one of the serious manifestations in COVID-19 patients[9]. Thereby we hypothesize that decreased testosterone levels in men have a direct relation with the severity of infection and a worse outcome in COVID-19. In this case we should found an appropriate treatment that induces testosterone level to introduce its protective effect and up regulate pulmonary protective pathways and at the same time protect against thrombosis and works to reduce the impact of dihydrotestosterone on lung cells preventing up regulation of TMPRSS2, Her we shed new light on the appropriate treatment can overcome the challenges that face testosterone therapy in the era of COVID-19 After searching MEDLINE , PubMed, , Google Scholar, preprints and Controlled Trials until September , 2020 we found that the appropriate treatment in this case is aerosolized 13 cis retinoic acid in combination with testosterone therapy, as more than one study found that 13 cis retinoic acid reversibly and potentially inhibit the effect of dihydrotestosterone on different targeted cells. In addition its impact on thrombin.
NCT04625114 The Potential of Oral Camostat in Early COVID-19 Disease in an Ambulatory Setting to Reduce Viral Load and Disease Burden Recruiting Phase 2 2020-11-04 The investigators are conducting a pilot trial where they will study safety, efficacy and compliance in a cohort of ambulatory patients in the Ghent region with confirmed COVID-19 infection, in both an early stage of disease, defined as less than 5 days of symptoms and who at presentation do not meet any criteria for hospitalisation as well as asymptomatic individuals with a PCR CT value below 30. The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load. The aim of the study is to assess whether Camostat, a serine protease inhibitor available in an oral formulation has the potential to be studied as an antiviral drug in a large scale ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the occurrence of early symptomatology.
NCT04625725 Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. Not yet recruiting Phase 3 2020-11-17 This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.
NCT04625972 Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults Not yet recruiting Phase 3 2020-11-16 This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.
NCT04628143 A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia Not yet recruiting Phase 2 2020-11-20 The primary objective of this study is to evaluate the efficacy of CKD-314 (Nafabelltan) compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale in hospitalized adult patients diagnosed with COVID-19 pneumonia
NCT04631536 Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC Not yet recruiting Early Phase 1 2020-11-10 COVID-19 infection was shown to cause endothelial dysfunction . At the level of the endothelium the pathophysiological mechanisms have been hypothesized and were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impaired barrier function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant and pro-inflammatory pathways have been studied and as a result dexamethasone and anticoagulation became part of the standard therapies for the disease. However, so far, no RCT has been evaluated on targeting the vasoconstrictive and antioxidant pathways with an aim of revealing clinical benefit. So, with this trial we intend to provide a regiment composed of several medications we hypothesize will act on several downstream pathways that would improve endothelial function primarily via the increase in NO production and release. At the time of this proposal there has been no randomized trials evaluating or testing the use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients. As previously noted there has been a call to study these drugs and their effect after a strong research regarding their theorized effectiveness. For evidence, there was a recently published meta-analysis evaluating the role of statins in COVID-19 with preliminary findings suggested a reduction in fatal or severe disease by 30% and discredited the suggestion of harm, that emphasized on the need of well-designed randomized controlled trial to confirm the role of statins in COVID-19 patients. Our study would help determine the potential therapeutic effect of the endothelial protocol as adjunct to mainstream management. This study seeks to further our knowledge in treating COVID-19 to ultimately improve clinical outcomes and reduce complications.
NCT04632381 Intravenous Zotatifin in Adults With Mild or Moderate COVID-19 Not yet recruiting Phase 1 2020-11-16 To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.
NCT04632537 BCG Vaccination to Prevent COVID 19 Not yet recruiting Phase 3 2020-11-01 The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.
NCT04633772 Phase I/II for the Use of Angiotensin-(1-7) in COVID-19 Recruiting Phase 1/Phase 2 2020-08-05 The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that could be altered in COVID-19 patient and its supplementation may potentially helpful in this setting.
NCT04634799 Study To antagOnize Plasminogen Activator Inhibitor-1 in Severe COVID-19 Recruiting Phase 1/Phase 2 2020-11-16 This is a single-center, randomized double blind placebo controlled trial to evaluate the efficacy and safety of novel PAI-1 inhibitor (TM5614) for high-risk patients hospitalized with severe COVID-19 at Northwestern Memorial Hospital. The patients will be randomized in a 1:1 ratio to receive standard of care plus TM5614 or standard of care plus placebo.
NCT04636086 Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection Recruiting Phase 4 2020-11-12 The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
NCT04639466 A Synthetic MVA-based SARS-CoV-2 Vaccine, COH04S1, for the Prevention of COVID-19 Infection Recruiting Phase 1 2020-11-10 This phase I trial evaluates the side effects and best dose of COH04S1, a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. COH04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of this study is to determine the safety and the optimal dose of the COH04S1 vaccine.
NCT04640038 Contrast Enhanced Ultrasound in COVID-19 Recruiting Phase 3 2020-11-01 Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart and kidneys of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes. This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. We will enroll and evaluate 30 patients.
NCT04640181 Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT) Not yet recruiting Phase 2 2020-12-01 This study is a multicenter, randomized trial to study the potential benefit of treatments with a direct FXa inhibitor (rivaroxaban) versus standard of care dose subcutaneous low molecular weight heparin (LMWH) (Lovenox) in hospitalized subjects with COVID-19.
NCT04643691 Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS Recruiting Phase 2 2020-09-11 Coronavirus disease (COVID-19) is a current pandemic infection caused by an RNA virus called Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Severe forms of COVID-19 are most often responsible for isolated respiratory failure in the form of acute respiratory distress syndrome (ARDS), which accounts for most of the mortality. Angiotensin converting enzyme 2 (ACE2) has been shown to be a co-receptor for the entry of SARS-CoV-2 into cells and is likely to play a prolonged role in the pathogenesis of COVID-19. ACE2 and angiotensin (1-7) have been shown to be protective in a number of different lung lesion models. In a mouse model of acidic lung injury, negative regulation of ACE2 by COVID, the SARS virus responsible for the 2003 SARS outbreak, worsened the lung injury which was improved by treatment with ARBs. We believe that blocking the first RAS pathway at the end of the chain on the AT1r angiotensin 2 receptor may prevent the initiation of this chain reaction and limit decompensation secondary to the disruption of the equilibrium of the renin-angiotensin system. We have several molecules that block the AT1r angiotensin-2 receptor (ARBs) as well as a molecule that blocks the secretion of aldosterone (spironolactone). The main objective is to demonstrate the value of losartan and spironolactone therapy in the regulation of the renin-angiotensin system in improving the prognosis of patients infected with COVID-19 and suffering from acute respiratory distress syndrome. This is a prospective, multicenter, randomized, open-label, controlled, therapeutic trial studying two parallel groups. The population included in this study is any major patient in acute respiratory distress hospitalized in intensive care requiring oxygen support of at least 6L/min and suffering from a PCR-confirmed SARS-cov2 infection. The control group will benefit from the usual resuscitation management of COVID19 , and the experimental group will benefit from losartan and spironolactone treatment in addition to the usual management, according to the study protocol. The number of subjects required has been calculated and 45 patients for each group, for a total of 90 patients. The SOFA score at D7 will be compared between the "experimental" versus "control" groups using a mean comparison method. The comparison of this criterion and all secondary criteria of judgments between the 2 groups will be performed using a Student or Mann-Whitney test based on the normality of the distribution. The significance threshold will be set at 0.05. No intermediate analysis is scheduled. The analysis will be blinded. The main expected outcome is an improved prognosis with a decrease in the SOFA severity score at 7 days in resuscitation patients, resulting in an improvement in organ failure. The expected secondary results will be to show the interest of ARA2/Spironolactone treatment on oxygenation based on the PaO2/FiO2 ratio, mechanical ventilation duration and mortality.
NCT04646109 Ivermectin for Severe COVID-19 Management Completed Phase 3 2020-05-11 In this multicenter study; it was aimed to investigate the effectiveness and safety of ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no mutations which alter ivermectin metabolism and cause side effects.
NCT04646603 MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients Not yet recruiting Phase 1/Phase 2 2021-01-05 The Study is Designed as A Combined Phase I Double-Blind Randomized Placebo controlled/IIa, Randomized, Double-blind, Placebo controlled, Multi-center Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001 in Subjects Infected with SARS-CoV-2. Part A: To determine the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles of MRG-001 in asymptomatic SARS-CoV-2 infected subjects. Part B: To determine the safety and efficacy profile of MRG-001 in patients with moderate-to-severe COVID-19. A total of 132 subjects will be enrolled and randomized in 1:1 ratio to receive MRG-001 or placebo. All subjects will be treated with the best available treatment. The follow-up period is up to 28 days.
NCT04646655 Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 Recruiting Phase 3 2020-07-27 SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2<250) and/or increased D-dimer levels enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).
NCT04648800 Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland Recruiting Phase 3 2020-07-07 Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes. The aim of the study is to answer the following questions: 1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)? 2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects? 3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result? A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*. Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19. * to measure the level of cytokines involved in cell-mediated immunity process
NCT04650087 COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis Not yet recruiting Phase 3 2020-12-01 A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge
NCT04652115 A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19 Not yet recruiting Phase 2 2021-01-01 The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
NCT04652518 PureTech Phase 2 Study of LYT-100 in Post-acute COVID-19 Respiratory Disease Not yet recruiting Phase 2 2020-12-01 This study is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications
NCT04652648 Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts Completed Phase 4 2020-05-27 - organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23 - Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25 - Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27 - Additional study using this technique is warranted to look at reliability and cost-28 effectiveness
NCT04653831 Treatment With Pirfenidone for COVID-19 Related Severe ARDS Recruiting N/A 2020-11-08 A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC), compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or SoC (control arm).
NCT04655586 Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 Not yet recruiting Phase 2/Phase 3 2020-12-04 Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2, a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels.
NCT04657484 Comparison of Two Corticosteroid Regimens for Post-COVID Diffuse Lung Disease Recruiting N/A 2020-12-10 A proportion of patients with COVID-19 pneumonia have a prolonged course of illness. Some of these patients continue to have considerable respiratory symptoms or persistent hypoxemia. The CT abnormalities in these patients are often a combination of ground-glass opacities and patchy multifocal consolidation consistent with a pattern of OP. In several patients, these radiologic abnormalities persist. As with other forms of OP, patients with post-COVID OP or post COVID diffuse lung disease (PC-DLD) may benefit from treatment with oral glucocorticoids. The ideal dose of glucocorticoids for treating PC-DLD is unknown. In this study, we aim to compare the efficacy and safety of a medium dose and a low dose of prednisolone (as the initial dose) for the treatment of post-COVID. diffuse lung disease.
NCT04659304 Study Evaluating Safety, Tolerability and Efficacy of Allocetra-OTS in Patients With COVID-19 Not yet recruiting Phase 1 2021-03-01 Phase 1b, multi-center, single-blinded, randomized, placebo-controlled study, evaluating safety, tolerability and efficacy of different doses and regimens of Allocetra-OTS, in up to 50 adult patients with critical COVID-19.
NCT04659707 Hyperpolarized 129Xe MRI of Survivors of COVID-19 Not yet recruiting Phase 1 2021-01-01 The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.
NCT04661527 Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19 Recruiting Phase 2 2020-04-22 Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
NCT04661930 Fenofibrate for Patients With COVID-19 Requiring Hospitalization Recruiting Phase 3 2020-12-13 This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.
NCT04662060 COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol Not yet recruiting Phase 2 2021-01-01 The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients. COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.
NCT04662073 COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol Not yet recruiting Phase 2 2021-01-01 The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients. COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.
NCT04662086 COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol Not yet recruiting Phase 2 2021-01-01 The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients. COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.
NCT04662684 Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial Recruiting Phase 3 2020-10-16 The Michelle trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
NCT04663737 Evaluating Safety, Pharmacokinetics and Clinical Benefit of Silmitasertib (CX-4945) in Subjects With Moderate COVID-19 Recruiting Phase 2 2020-12-03 This single-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 20 subjects aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with moderate COVID-19. Two-arm trial comparing the SOC/supportive care alone to the SOC/supportive care with addition of Silmitasertib (allocation ratio 1:1).
NCT04665115 Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19) Not yet recruiting Phase 2 2020-12-31 This phase II trial studies the effects of ibrutinib in treating patients with B-cell malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ibrutinib is a first in class Bruton tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms better or worse.
NCT04667247 Mushroom-based Product for COVID-19 Recruiting Phase 1/Phase 2 2020-12-03 This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. The study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects.
NCT04667780 Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19 Recruiting Phase 3 2020-12-10 COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. The investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but no intensive care yet. Colchicine will be started within the first 48 hours and continue for 14 days using a descending dose. The benefits will be studied in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is affordable and widely accessible which would help to prevent the inflammatory complications associated with COVID-19.
NCT04668222 Changing Susceptible Body Constitution for COVID-19 Prevention by Chinese Medicine in Hong Kong Residents Not yet recruiting Phase 1/Phase 2 2020-12-15 Chinese medicine has been used for thousands of years in the treatment of epidemic diseases. Through the long-term struggle with the epidemic, Investigators have accumulated and explored a lot of prevention and control experience. According to recent reports, Chinese medicine plays an important role in the treatment of COVID-19. For example. Therefore, it is of great clinical significance to further develop the prevention of COVID-19 by Chinese medicine. According to the 《Diagnosis and treatment of COVID-19》published by National Health Committee and the experience of professional TCM physician, although the disease is generally susceptible, individuals with the body constitution of "deficiency of Qi and Yang" and "deficiency of Qi and Yin" are more prefer to suffer from COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing COVID-19 in Chinese medicine. After a series of questionnaire surveys and blood sample collection, investigators can estimate subjects with body constitution is more likely to infect COVID-19.
NCT04668235 Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected) Not yet recruiting Phase 3 2020-12-01 Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study.
NCT04668469 Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic Completed N/A 2020-06-08 Background: Up-to-date, there is no recognized effective treatment or vaccine for the treatment of coronavirus disease (COVID-19) that emphasize urgency around distinctive effective therapies. This study aims to evaluate the anti-parasitic medication efficacy "Ivermectin" plus standard care (Azithromycin, Paracetamol, vitamin C, Zinc, Lactoferrin, Acetylcystein, prophylactic or therapeutic anticoagulation if D-dimer > 1000 and/or steroids) in the treatment of mild/moderate and severely ill cases with COVID 19 infection versus Hydroxychloroquine plus standard care, as well as Ivermectin prophylaxis of health care and/ or household contacts. Subject and methods: 600 subjects; 400 symptomatic confirmed COVID-19 patients and 200 health care and household contacts distributed over 6 groups; Group I: 100 patients with Mild/Moderate COVID-19 infection received a 4-days course of Ivermectin plus standard care; Group II: 100 patients with mild/moderate COVID-19 infection received hydroxychlorquine plus standard care; Group III: 100 patients with severe COVID-19 infection received Ivermectin plus standard of care; Group IV: 100 patients with Severe COVID-19 infection received hydroxychlorquine plus standard care. Routine laboratory investigations and real time- polymerase chain reaction (rt-PCR) were reported before and after initiation of treatment. Group V stick to personal protective equipment (PPE) plus Ivermectin, and Group VI stick to PPE only and both groups were followed for two weeks.
NCT04673162 Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients Not yet recruiting Phase 3 2020-12-01 This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.
NCT04673214 Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment, a Randomized Clinical Trial Recruiting Phase 3 2020-12-16 The present study is designed for patients with mild COVID-19 phase, to demonstrate if there is a modification in the clinical evolution greater than or equal to 25% in their symptoms, implemented in two groups of patients under an early intervention treatment, a group ( A) will receive Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and another group (B) will receive Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call
NCT04678830 COVID-19 Long-Haulers Study Not yet recruiting Phase 2 2020-12-21 The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms (> 6 weeks) of COVID-19.
NCT04680949 suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19 Not yet recruiting Phase 3 2020-12-21 The SAVE-MORE is a pivotal, confirmatory, phase III randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale (CPS).
NCT04681430 Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals Not yet recruiting Phase 2 2021-01-01 This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.
NCT04682873 A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19 Recruiting Phase 3 2020-05-15 Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial. Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29. The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of treatment-emergent adverse events (TEAEs). Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.
NCT04694612 Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal Recruiting Phase 3 2021-01-01 COVID-19 has affected almost all countries in the world. Every other country is constantly working towards its treatment and development of vaccines, with little to no success so far. Recently, several regimens have been tried as antiviral medicine. Among these medicines, Favipiravir is considered a broad-spectrum antiviral with the spectrum of activity noted against a wide range of RNA viruses & a good oral antiviral drug with > 97% bioavailability. It has already proved its safety profile as it has received FDA indication for drug-resistant Influenza. There has been increasing evidence of favorable outcome against COVID-19 in terms of early viral clearance & quicker symptomatic relief however, most of these studies lack strong statistical significance & are not peer-reviewed. Subjects will be categorized into two arms based on the severity of infection due to COVID-19 defined by NMC guidelines. Each arm will have respective two groups as the study drug group and control group. Based on the sample size calculation, subjects will be stratified & randomly enrolled in the study after checking the eligibility criteria at the screening visit. About 276 mild patients will be recruited for this trial and 400 moderate patients (including 10% loss ). Study arm groups will receive a Favipiravir treatment of 1800 mg PO BID on day 1, then 800 mg PO BID from day 2 onwards and control groups will receive the same quantity of Placebo. Treatment will be continued till 5 days after for mild groups and 10 days for moderate groups. Eligible patients will be randomly assigned (1:1) to either Favipiravir or Placebo among mild cases; and Favipiravir or Remdesivir among moderate cases. Randomization will be stratified by age group (18 to 40 years, 40 to 60 years and 60 to 80 years) and co-morbidity. The permuted block (30 patients per block) randomization sequence, including stratification, will be prepared by a statistician using STATA-15 software. Eligible patients will be allocated to the respective arm and will receive individually numbered packs, according to the sequence order as informed by the hotline. Informed written consent will be taken from the participants before commencing the study. All safety data, patient's baseline, clinical outcome data, data from endpoints and variables should be reported by the clinician and his/her team in a pre-instructed case report form (CRF) via a designated website. It is our assumption that if the study results come favorable, Favipiravir, when used in mild or moderate cases, might prevent progression of the disease to higher severity, helps achieve viral clearance early so as to positively impact disease transmission in the community, increase the quality of life by quicker symptom recovery & decrease health burden by shortening the length of stay at the hospital. These findings can also be useful in international scenarios where the world is looking for innovative measures to curb COVID-19 infection. The study findings will be disseminated within and outside the country and will be published in peer-reviewed journals.
NCT04695197 Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso Not yet recruiting Phase 3 2021-01-08 It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.
NCT04705597 Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Participants ≥ 60 Years of Age and Hospitalized With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure Not yet recruiting Phase 2 2021-02-01 The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 60 years of age hospitalized with documented COVID-19.
NCT04707534 Dexamethasone for COVID-19 Not yet recruiting Phase 4 2021-01-11 This open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using World Health Organization ordinal scale at day 28 in hospitalized patients with COVID-19.
NCT04707664 Sargramostim Use in COVID-19 to Recover Patient Health (SCOPE) Not yet recruiting Phase 2 2021-02-01 The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room and hospitalization related to COVID-19 or death.
NCT04707703 Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis Not yet recruiting Phase 3 2021-01-01 The objective of this study is to evaluate whether antifungal prophylaxis with isavuconazole can reduce the incidence of SARS-CoV-2-associated invasive aspergillosis in patients in the ICU (intensive care unit) with severe COVID-19 infection. The investigators will perform an interventional, double-blinded, randomized-controlled, multi-center study in patients with severe COVID-19 infection admitted to the ICU. Patients will be randomized to the isavuconazole prophylaxis plus standard of care (SOC) group or the placebo plus SOC group. Participants will receive isavuconazole or placebo for up to 28 days or until discharge from the hospital (whichever occurs first).
NCT04708340 Tolerability and Efficacy of RJX in Patients With COVID-19 Not yet recruiting Phase 1/Phase 2 2021-02-01 This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.
NCT04709172 Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia Recruiting Phase 4 2021-01-05 The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in December 2019, and has since spread worldwide. The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care. Recent publications show that a significant number of COVID-19 patients are co-infected with one or more pathogens. Most co-infections occurred within 1-4 days of onset of COVID-19 disease and a considerable number of patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin and not severe enough for requiring hospitalization. It therefore seems reasonable to adopt therapeutic strategies for these patients that are effective and easy to follow in the outpatient setting. Cefditoren (CDN) is a third-generation cephalosporin for oral administration. CDN has a broad spectrum of activity and is particularly active against the bacterial pathogens involved in community respiratory tract infections. Besides that, the use of CDN has been associated with a marked decrease in circulating levels of IL-6 and other pro-inflammatory cytokines and mediators of epithelial damage. The aim of this study is to demonstrate that CDN improves clinical condition in patients with mild-moderate COVID-19 and symptoms of bacterial pneumonia.
NCT04710199 Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) Not yet recruiting Phase 2 2021-02-01 Maraviroc (MVC) is a drug, very well tolerated, it has been seen that MVC has properties of modulating the immune system, exerting an anti-inflammatory effect in different diseases. In COVID-19, very high levels of inflammation occur that cause organs and systems to be damaged. MVC could reduce this inflammation achieving a better prognosis of COVID-19.
NCT04711863 Fluvoxamine for Adults With Mild to Moderate COVID-19 Not yet recruiting Phase 2 2021-01-15 This clinical trial aims to determine if fluvoxamine, a selective serotonin reuptake inhibitor with high affinity for the sigma-1 receptor, can be used in mild to moderate COVID-19 to prevent the progression to severe COVID-19. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder and has a potential for immune modulation as a sigma-1 receptor agonist. The investigational use of fluvoxamine for the treatment of COVID-19 is approved by the South Korean Ministry of Food and Drug Safety. This study is performed fully-remotely at COVID-19 community treatment centers, temporary facilities in Seoul, Korea, to accommodate and monitor asymptomatic to moderately symptomatic case-patients who do not require hospital admission.
NCT04712279 The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial) Not yet recruiting Phase 2/Phase 3 2021-01-25 Ivermectin, a classical antiparasitic and anti-scabies agent, has demonstrated antiviral activity for a variety of viruses including chikungunya virus, zyka virus and dengue virus and was tested as a potentially effective for COVID-19. Although ivermectin demonstrated potent in vitro action by reducing viral load by 5000x after 48 hours of incubation, simultaneous pharmacokinetics simulations suggested that the minimum effective concentrations would be unfeasible to be reached within safety range (EC-50 = 2 Micromol). However, despite the theoretical unfeasible concentrations to be achieved, preliminary observational yet well-structured studies followed by randomized clinical trials (RCTs) demonstrated ivermectin efficacy when combined with hydroxychloroquine, doxycycline or azithromycin, which was corroborated by a recent systematic review and metanalysis. In common, a dose-response effect for effectiveness was observed, and no adverse effects was reported at any dose between 0.2mg/kg/day and 1.0mg/kg/day. Based on the scientific rationale combined with the preliminary evidence, ivermectin has sufficient evidence to be tested in higher doses in a RCT for COVID-19. The investigators propose to test ivermectin at high doses as a treatment for patients recently diagnosed with COVID-19, aiming to explore the possible protective role of high-dose ivermectin in SARS-CoV-2 infection in terms of reduction of clinic and virologic disease duration, and prevention of oxygen use, hospitalization, mechanical ventilation, death, and post-COVID persisting symptoms.
NCT04712357 Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19 Recruiting N/A 2020-11-09 Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and emtricitabine for Covid-19
NCT04715295 Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19 Recruiting Phase 4 2020-10-05 This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to treat ambulatory mild COVID-19 patients, with the aim to achieve early negativity of RT-PCR of SARS-CoV-2 from nasopharyngeal swab, and early clinical improvement and prevention of severe disease.
NCT04715932 Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN) Not yet recruiting Phase 2 2021-01-21 The main aim of this study is to determine the effects of short-term treatment with hesperidin on COVID-19 symptoms in comparison with a placebo. Treatment effects will be observed through a symptoms diary that will be completed by participants throughout the study and by taking the oral temperature daily.
NCT04715997 Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults Recruiting Phase 1/Phase 2 2020-12-30 The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
NCT04716426 APT™ T3X on the COVID-19 Contamination Rate Not yet recruiting N/A 2021-01-01 The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of contamination are still important alternatives at this time of the pandemic. APT™ T3X is an FDA Registered, Over-the-Counter (non-prescription) ointment. This formulation is used in an off label manner as an intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical application will penetrate through and into the mucus layer and deeper. This barrier of coverage will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus. Previous tests were performed with APT™ T3X and the results found were promising. However, these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the possible prophylactic effect, allowing the formulation to be widely distributed to the general population. Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to placebo to decrease COVID-19 contamination rate in humans.
Trial ID Title Status Phase Start Date Summary

baricitinib

Finished product suppliers for baricitinib

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924 NDA Eli Lilly and Company 0002-4182-30 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-30)
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924 NDA Eli Lilly and Company 0002-4182-61 30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-61)
Eli Lilly And Co OLUMIANT baricitinib TABLET;ORAL 207924 NDA Eli Lilly and Company 0002-4732-30 30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

API manufacturers for baricitinib

Vendor Vendor Homepage Vendor Sku API Url
BioChemPartner http://www.biochempartner.com/ BCP0726000031
BioChemPartner http://www.biochempartner.com BCP9000380
MedChemexpress MCE https://www.medchemexpress.com/ HY-15315 https://www.medchemexpress.com/Baricitinib.html
AbaChemScene https://www.chemscene.com/ CS-0724 http://www.chemscene.com/1187594-09-7.html
Acesobio http://www.acesobio.com cc-652
CEGChem http://www.cegchemical.com QCR-197 http://www.cegchemical.com/web/products3_goodscode_QCR-197.html
ApexBio Technology http://www.apexbt.com A4141 http://www.apexbt.com/baricitinib-ly3009104-incb028050.html
Synblock Inc http://www.synblock.com/ PB27275 http://www.synblock.com/product/1187595-84-1.html
Apexmol http://www.apexmol.com/ AM81232 http://www.apexmol.com/product/AM81232.html
Wutech http://www.rennotech.com RL00725 http://www.rennotech.com/product_show.asp?id=264
Ark Pharm, Inc. http://www.arkpharminc.com/ AK143352 http://www.arkpharminc.com/products/1187594-09-7.html
Aurum Pharmatech LLC http://www.Aurumpharmatech.com S-7686 http://www.Aurumpharmatech.com/Product/ProductDetails/S_7686
MolPort https://www.molport.com MolPort-023-219-125 https://www.molport.com/shop/molecule-link/MolPort-023-219-125
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS022186127 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS022186127
Assembly Blocks Pvt. Ltd. http://www.assemblyblocks.com AB0035958
A&J Pharmtech CO., LTD. http://www.ajpharmtech.com/ AJ-121247 http://www.ajpharmtech.com/
MolPort https://www.molport.com MolPort-035-683-655 https://www.molport.com/shop/molecule-link/MolPort-035-683-655
Sun-shinechem http://www.sun-shinechem.com/ Baricitinib http://www.sun-shinechem.com/1187594-09-7.html
Acemol https://www.acemol.com AMMD00005 http://www.acemol.com/products/PAMMD00005.shtml
Active Biopharma http://www.activebiopharma.com/ ABP001023 http://www.activebiopharma.com/1187594-09-7
Axon Medchem https://www.axonmedchem.com/product/1955 1955
Race Chemical http://www.racechemical.com RV022503588
Molepedia http://www.molepedia.com/ M91109289P http://www.molepedia.com/
AOBIOUS INC http://aobious.com AOB87724
AK Scientific, Inc. (AKSCI) http://www.aksci.com Y0439 http://www.aksci.com/item_detail.php?cat=Y0439
Alsachim http://www.alsachim.com 4636 http://www.alsachim.com/product-C5984-glo.bal-view.html
BOC Sciences https://www.bocsci.com/ 1187594-09-7 https://www.bocsci.com/baricitinib-cas-1187594-09-7-item-286344.html
A2Z Chemical http://www.a2zchemical.com AZM13316 http://www.a2zchemical.com/AZM13316.html
Zjartschem http://www.zjartschem.com/eacpzs.asp?dlb_id=12 Intermediates-ZCF05394 http://www.zjartschem.com/eacpzs.asp?key=1187594-09-7&imageField.x=22&imageField.y=21
OXCHEM CORPORATION http://www.ox-chem.com AX8261519 http://www.ox-chem.com/pc/en/product_item.aspx?ID=AX8261519
ZINC http://zinc15.docking.org ZINC73069247 http://zinc.docking.org/substances/ZINC73069247/
BePharm Ltd. http://www.bepharm.com B261519 http://www.bepharm.com/web/en/product/pro_item.aspx?id=B261519
Boerchem http://www.boerchem.com BC600315 http://www.boerchem.com/?product_43150.html
Aurora Fine Chemicals LLC http://www.aurorafinechemicals.com A17.866.933 http://online.aurorafinechemicals.com/info?ID=A17.866.933
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS025401933 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS025401933
ChemShuttle http://www.chemshuttle.com 109730 http://www.chemshuttle.com/catalogsearch/result/?q=1187594-09-7&cat=
Biosynth Carbosynth http://www.biosynth.com/ J-503551 https://www.biosynth.com/en/products/all-products/products/J-503551.html
TargetMol (Target Molecule Corp.) http://www.targetmol.com/ T2485 http://www.targetmol.com/compound/Baricitinib
Hangzhou APIChem Technology http://www.apichemistry.com AC-27404
ApexBio Technology http://www.apexbt.com A3222 http://www.apexbt.com/baricitinib-phosphate.html
labseeker https://www.labseeker.com SC-94301 http://www.labseeker.com/goods.php?id=72429
Angene Chemical http://www.angenechemical.com AGN-PC-0WA3Y8 http://www.angenechemical.com/productshow/AGN-PC-0WA3Y8.html
eNovation Chemicals D372447 http://www.enovationchem.com/productDetails.asp?productID=D372447
AbovChem LLC http://www.abovchem.com HY-15315
Acadechem https://www.acadechemical.com ACDS-068229 http://www.acadechemical.com/product/142928
Pi Chemicals http://www.pipharm.com PI-37032 http://www.pipharm.com/catalog/PI-37032.html
abcr GmbH http://www.abcr.de/en/homepage/ AB453191 http://www.abcr.de/shop/en/AB453191
AvaChem Scientific http://www.avachem.com/productSearch.asp?3630 3630 http://www.avachem.com/productSearch.asp?3630
AEchem Scientific Corp., USA https://www.aechemsc.com AE049545 http://www.aechemsc.com/info_products/AE049545.php
Activate Scientific https://activate-scientific.com AS10224 https://shop.activate-scientific.com/code/AS10224
DC Chemicals https://www.dcchemicals.com DC5064 http://www.dcchemicals.com/product_show-Baricitinib_INCB28050_LY3009104_.html
Wubei-Biochem http://www.wubei-biochem.com/ WB054827SU http://wubei-biochem.com/product/625415
King Scientific http://www.kingscientific.com KS-0000044L http://www.kingscientific.com/goods/Goods/detail?id=KS-0000044L
Yuhao Chemical http://www.chemyuhao.com/ RT14510 http://www.chemyuhao.com/1187594-09-7.html
Selleck Chemicals http://www.selleckchem.com/ S2851 http://www.selleckchem.com/products/baricitinib-ly3009104.html
AbMole Bioscience http://www.abmole.com/ M2039 http://www.abmole.com/products/baricitinib.html
Chemieliva Pharmaceutical Co., Ltd http://www.chemieliva.com PBCM0126180
Shanghai Send Pharmaceutical Technology Co., Ltd http://shsendpharm.com/ send21141 http://shsendpharm.com/
Cangzhou Enke Pharma Tech Co.,Ltd. http://www.enkepharma.com/indexe.php ENKE1187594097
Chemenu Inc. http://www.chemenu.com/ CM105935 http://www.chemenu.com/products/CM105935
MuseChem https://www.musechem.com I000674 https://www.musechem.com/product/I000674.html
Key Organics/BIONET https://www.keyorganics.net/bionet/ DS-7641 http://www.keyorganics.net/bionet/catalog/product/view/id/867971
Ambinter http://www.ambinter.com Amb22370255 http://www.ambinter.com/reference/22370255
Ambinter http://www.ambinter.com Amb22491663 http://www.ambinter.com/reference/22491663
AA BLOCKS http://www.aablocks.com AA003A32 https://www.aablocks.com/goods/Goods/detail?id=AA003A32
Uchem Meditech http://www.uchemmed.com/ U2762 http://www.uchemmed.com/790-Baricitinib%20(LY3009104,%20INCB028050).html
BioChemPartner http://www.biochempartner.com/ BCP04686 http://www.biochempartner.com/1187594-09-7-BCP04686
eNovation Chemicals D495627 https://www.enovationchem.com/ProductDetails.asp?ProductID=D495627
Ambeed https://www.ambeed.com/ A102707 https://www.ambeed.com/products/1187594-09-7.html
iChemical Technology USA Inc http://www.ichemical.com EBD2199373 http://www.ichemical.com/products/1187594-09-7.html
Synblock Inc http://www.synblock.com/ SB10845 http://www.synblock.com/product/1187594-09-7.html
Achemtek http://achemtek.com/ 0102-013841 http://www.achemtek.com/1187594-09-7
BioCrick https://www.biocrick.com/ BCC2195 http://www.biocrick.com/Baricitinib-LY3009104-INCB028050-BCC2195.html
Norris Pharm http://www.norris-pharm.com/ NSZB-A213860
Adooq BioScience https://www.adooq.com/ A11329 https://www.adooq.com/baricitinib.html
Angel Pharmatech Ltd. https://www.angelpharmatech.com AG-11289 http://www.angelpharmatech.com/1187594-09-7.html
CSNpharm http://www.csnpharm.com CSN13692 https://www.csnpharm.com/products/baricitinib.html
eNovation Chemicals D621217 https://www.enovationchem.com/ProductDetails.asp?ProductID=D621217
Clearsynth https://www.clearsynth.com/ CS-T-48553 https://www.clearsynth.com/en/CST48553.html
Sinfoo Biotech http://sinfoobiotech.com/ S052572 http://www.sinfoobiotech.com/product/1055970
MolCore BioPharmatech https://www.molcore.com/ MC459479 https://www.molcore.com/product/1187594-09-7
MolCore BioPharmatech https://www.molcore.com/ MC509857 https://www.molcore.com/product/1187595-84-1
Finetech Industry Limited https://www.finetechnology-ind.com FT-0775037 https://www.finetechnology-ind.com/prod/detail/pub/1187594-09-7.html
Aaron Chemicals LLC http://www.aaronchem.com/ AR003AUU http://www.aaronchem.com/1187594-09-7
Matrix Scientific https://www.matrixscientific.com 112533 https://www.matrixscientific.com/112533.html
Lan Pharmatech http://www.lanpharmatech.com LAN-B00195 http://www.lanpharmatech.com/product-9?_keywords=LAN-B00195
THE BioTek https://www.thebiotek.com/ bt-253529 https://www.thebiotek.com/product/inhibitors/bt-253529
THE BioTek https://www.thebiotek.com/ bt-260938 https://www.thebiotek.com/product/inhibitors/bt-260938
Chem-Space.com Database https://chem-space.com CSSB00015190072 https://chem-space.com/CSSB00015190072
Smolecule https://www.smolecule.com/ S001993 http://www.smolecule.com/products/s001993
Smolecule https://www.smolecule.com/ S520451 http://www.smolecule.com/products/s520451
Win-Win Chemical https://www.win-winchemical.com/ 19466
Vendor Vendor Homepage Vendor Sku API Url

bevacizumab

Suppliers for bevacizumab

Applicant Tradename Biologic Ingredient Dosage BLA NDA/ANDA Supplier Package Code Package
Genentech AVASTIN bevacizumab VIAL; INTRAVENOUS 125085 BLA Genentech, Inc. 50242-060-01 1 VIAL, SINGLE-USE in 1 CARTON (50242-060-01) > 4 mL in 1 VIAL, SINGLE-USE
Genentech AVASTIN bevacizumab VIAL; INTRAVENOUS 125085 BLA Genentech, Inc. 50242-060-10 10 VIAL, SINGLE-USE in 1 CARTON (50242-060-10) > 4 mL in 1 VIAL, SINGLE-USE
Genentech AVASTIN bevacizumab VIAL; INTRAVENOUS 125085 BLA Genentech, Inc. 50242-061-01 1 VIAL, SINGLE-USE in 1 CARTON (50242-061-01) > 16 mL in 1 VIAL, SINGLE-USE
Genentech AVASTIN bevacizumab VIAL; INTRAVENOUS 125085 BLA Genentech, Inc. 50242-061-10 10 VIAL, SINGLE-USE in 1 CARTON (50242-061-10) > 16 mL in 1 VIAL, SINGLE-USE
Applicant Tradename Biologic Ingredient Dosage BLA NDA/ANDA Supplier Package Code Package

chloroquine hydrochloride

API manufacturers for chloroquine hydrochloride

Drug Master Files for chloroquine hydrochloride

DMF No. Status Type Submission Date Holder Subject
10472 I II 9/10/1993 ICN HUNGARY CO LTD CHLOROQUINE PHOSPHATE
12762 I II 11/12/1997 ALKALOIDA CHEMICAL CO LTD HYDROXYCHLOROQUINE SULFATE
14087 A II 4/17/1999 IPCA LABORATORIES LTD HYDROXYCHLOROQUINE SULFATE USP
14977 A II 8/1/2000 CADILA HEALTHCARE LTD HYDROXYCHLOROQUINE SULFATE USP
20692 A II 7/17/2007 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD HYDROXYCHLOROQUINE SULFATE
21115 I II 2/6/2008 WUHAN WUYAO PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG
21567 A II 4/25/2008 AMRI RENSSELAER INC HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE
23582 A II 3/25/2010 ALKALOIDA CHEMICAL CO ZRT HYDROXYCHLOROQUINE SULFATE USP
23593 I II 3/12/2010 UNIMARK REMEDIES LTD HYDROXYCHLOROQUINE SULFATE USP
25709 I II 1/9/2012 SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE (USP)
30014 A II 11/24/2015 FERMION OY HYDROXYCHLOROQUINE SULPHATE
30825 A II 8/1/2016 CHONGQING KANGLE PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP
31956 A II 9/8/2017 LAURUS LABS LTD HYDROXYCHLOROQUINE SULFATE USP
3916 I II 7/21/1980 FBA PHARMACEUTICALS INC DIV BAYCHEM CORP CHLOROQUINE DIPHOSPHATE
4693 I II 10/13/1982 SANOFI SYNTHELABO INC HYDROXYCHLOROQUINE SULFATE
6425 I II 6/11/1986 SANOFI PHARMACEUTICALS INC CHLOROQUINE BASE AND PHOSPHATE
8487 I II 3/22/1990 ABBOTT LABORATORIES HYROCHLOROQUINE SULFATE
8619 A II 6/27/1990 SCI PHARMTECH INC HYDROXYCHLOROQUINE SULFATE
9235 A II 7/2/1991 IPCA LABORATORIES LTD CHLOROQUINE PHOSPHATE USP
9490 I II 12/6/1991 SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE
DMF No. Status Type Submission Date Holder Subject

chloroquine phosphate

Finished product suppliers for chloroquine phosphate

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 091621 ANDA A-S Medication Solutions 50090-4967-3 40 TABLET in 1 BOTTLE (50090-4967-3)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 091621 ANDA Rising Pharmaceuticals, Inc. 64980-177-01 100 TABLET in 1 BOTTLE, PLASTIC (64980-177-01)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 091621 ANDA Rising Pharmaceuticals, Inc. 64980-177-05 500 TABLET in 1 BOTTLE, PLASTIC (64980-177-05)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 091621 ANDA Rising Pharmaceuticals, Inc. 64980-177-10 1000 TABLET in 1 BOTTLE, PLASTIC (64980-177-10)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 091621 ANDA Rising Pharmaceuticals, Inc. 64980-177-50 50 TABLET in 1 BOTTLE, PLASTIC (64980-177-50)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 090612 ANDA Rising Pharmaceuticals, Inc. 64980-178-01 100 TABLET in 1 BOTTLE, PLASTIC (64980-178-01)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 090612 ANDA Rising Pharmaceuticals, Inc. 64980-178-02 25 TABLET in 1 BOTTLE, PLASTIC (64980-178-02)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 090612 ANDA Rising Pharmaceuticals, Inc. 64980-178-05 500 TABLET in 1 BOTTLE, PLASTIC (64980-178-05)
Natco Pharma Ltd CHLOROQUINE PHOSPHATE chloroquine phosphate TABLET;ORAL 090612 ANDA Rising Pharmaceuticals, Inc. 64980-178-10 1000 TABLET in 1 BOTTLE, PLASTIC (64980-178-10)
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

API manufacturers for chloroquine phosphate

Vendor Vendor Homepage Vendor Sku API Url
Sigma-Aldrich http://www.sigmaaldrich.com C6628_SIGMA https://www.sigmaaldrich.com/catalog/product/sigma/c6628?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
NovoSeek http://www.novoseek.com 64927 http://www.novoseek.com/AccessPoint.action?corpus=MEDLINE&externalDBId=cid%3d64927&DBName=pubchem&actionName=search&bioType=drug
TCI (Tokyo Chemical Industry) http://www.tcichemicals.com/en/us/ C2301 http://www.tcichemicals.com/eshop/en/us/commodity/C2301/index.html
MolPort https://www.molport.com MolPort-003-665-488 https://www.molport.com/shop/molecule-link/MolPort-003-665-488
Hangzhou APIChem Technology http://www.apichemistry.com AC-12463
ABI Chem http://www.abichem.com AC1L228G
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS004910410 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS004910410
ABI Chem http://www.abichem.com AC1Q6RTA
ChemMol http://chemmol.com/suppliers/ChemMol/301/1/ 30102220 http://www.chemmol.com/chemmol/30102220.html
ChemMol http://chemmol.com/suppliers/ChemMol/440/1/ 44003241 http://www.chemmol.com/chemmol/44003241.html
ChemMol http://chemmol.com/suppliers/ChemMol/440/1/ 44001911 http://www.chemmol.com/chemmol/44001911.html
ChemMol http://chemmol.com/suppliers/ChemMol/494/1/ 49417176 http://www.chemmol.com/chemmol/49417176.html
Anward http://www.anward.com ANW-43957 http://www.anward.com/pro_result/22053
Chembase.cn http://www.chembase.cn 134201 http://www.chembase.cn/molecule-134201.html
ChemTik http://www.chemtik.com/ CTK8B4126 http://www.chemtik.com/pro_result/814126/
Rosewachem http://www.rosewachem.com RW2763
Finetech Industry Limited http://www.finetechnology-ind.com FT-0602804 http://www.finetechnology-ind.com/prod/detail/pub/50-63-5.html
Mcule https://mcule.com MCULE-4724842928 https://mcule.com/MCULE-4724842928/
Ark Pharm, Inc. http://www.arkpharminc.com/ AK142896 http://www.arkpharminc.com/products/50-63-5.html
Boerchem http://www.boerchem.com/ BC204679 http://www.boerchem.com/?product_34448.html
Alsachim http://www.alsachim.com 1353 http://www.alsachim.com/product-C1741-glo.bal-view.html
AN PharmaTech http://www.anpharma.net AN-24378
Aurum Pharmatech LLC http://www.Aurumpharmatech.com NE31607 http://www.Aurumpharmatech.com/Product/ProductDetails/NE31607
Life Chemicals http://www.lifechemicals.com F2173-1139 https://shop.lifechemicals.com/2/F2173-1139
Tocris Bioscience https://www.tocris.com 4109 https://www.tocris.com/products/chloroquine-diphosphate_4109
Axon Medchem https://www.axonmedchem.com/product/2431 2431
AHH Chemical co.,ltd http://www.ahhchemical.com API-1739 http://www.ahhchemical.com/product/API-1739.html
BOC Sciences https://www.bocsci.com/ 50-63-5 https://www.bocsci.com/chloroquine-diphosphate-cas-50-63-5-item-344737.html
MedChemexpress MCE https://www.medchemexpress.com/ HY-17589 https://www.medchemexpress.com/Chloroquine-diphosphate.html
Glentham Life Sciences Ltd. http://www.glentham.com GA7477 http://www.glentham.com/products/product/GA7477/
AbaChemScene https://www.chemscene.com/ CS-3811 http://www.chemscene.com/50-63-5.html
Clearsynth https://www.clearsynth.com/ CS-O-06225 https://www.clearsynth.com/en/CSO06225.html
Phion Ltd http://www.phionchemicals.com 79469515 http://phionchemicals.com/product-tag/50-63-5
abcr GmbH http://www.abcr.de/en/homepage/ AB261388 http://www.abcr.de/shop/en/AB261388
Parchem http://www.parchem.com 10858 http://www.parchem.com/chemical-supplier-distributor/Chloroquine-Diphosphate-Sulfate-000858.aspx
iChemical Technology USA Inc https://www.ichemical.com EBD17158 http://www.ichemical.com/products/50-63-5.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
Yuhao Chemical http://www.chemyuhao.com HL1042 http://www.chemyuhao.com/50-63-5.html
Pi Chemicals http://www.pipharm.com PI-15723 http://www.pipharm.com/catalog/PI-15723.html
VladaChem https://www.vladachem.com VL141366 https://www.vladachem.com/product.php?products=50-63-5
Sigma-Aldrich http://www.sigmaaldrich.com 1118000_USP https://www.sigmaaldrich.com/catalog/product/usp/1118000?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com PHR1258_SIAL https://www.sigmaaldrich.com/catalog/product/sial/phr1258?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Acorn PharmaTech Product List http://www.acornpharmatech.com ACN-048722 http://www.acornpharmatech.com/
LGC Standards https://www.lgcstandards.com LGCFOR1055.00 https://www.lgcstandards.com/US/en/p/LGCFOR1055.00
OChem https://www.ocheminc.com 1210 http://www.ocheminc.com/index.php?act=psearch&pid=069C852
King Scientific http://www.kingscientific.com KS-00000RXN http://www.kingscientific.com/goods/Goods/detail?id=KS-00000RXN
AbMole Bioscience http://www.abmole.com/ M2510 http://www.abmole.com/products/chloroquine-phosphate.html
Chemieliva Pharmaceutical Co., Ltd http://www.chemieliva.com PBCM0603972
DC Chemicals https://www.dcchemicals.com DC9169 http://www.dcchemicals.com/product_show-Chloroquine_diphosphate.html
Chemenu Inc. http://www.chemenu.com/ CM110476 http://www.chemenu.com/products/CM110476
LGC Standards https://www.lgcstandards.com DRE-C11506000 https://www.lgcstandards.com/US/en/p/DRE-C11506000
MuseChem https://www.musechem.com A000578 https://www.musechem.com/product/A000578.html
Yuhao Chemical http://www.chemyuhao.com YH06138 http://www.chemyuhao.com/54-05-7.html
MolMall http://www.molmall.net/what-makes-us-different.html 20787 http://www.molmall.net/product/20787
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B2-0766 http://www.3bsc.com/index/pro_info.php?id=20122
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B1-00240 http://www.3bsc.com/index/pro_info.php?id=20452
BLD Pharm https://www.bldpharm.com/ BD263139 http://www.bldpharm.com/products/50-63-5.html
Uchem Meditech http://www.uchemmed.com/ U2908 http://www.uchemmed.com/945-Chloroquine%20Phosphate.html
Hairui Chemical http://www.hairuichem.com/en/ HR145207 http://www.hairuichem.com/en/product/50-63-5.html
Ambeed https://www.ambeed.com/ A233637 https://www.ambeed.com/products/50-63-5.html
Acros Organics https://www.fishersci.com AC455240250 https://www.fishersci.com/shop/products/chloroquine-diphosphate-salt-98-acros-organics-2/AC455240250
Acros Organics https://www.fishersci.com AC455241000 https://www.fishersci.com/shop/products/chloroquine-diphosphate-salt-98-acros-organics-1/AC455241000
Acros Organics https://www.fishersci.com AC455245000 https://www.fishersci.com/shop/products/chloroquine-diphosphate-salt-98-acros-organics/AC455245000
LGC Standards https://www.lgcstandards.com MM1055.00-0250 https://www.lgcstandards.com/US/en/p/MM1055.00-0250
Achemtek http://achemtek.com/ 0104-013172 http://www.achemtek.com/50-63-5
BioCrick https://www.biocrick.com/ BCC3915 http://www.biocrick.com/Chloroquine-diphosphate-BCC3915.html
CSNpharm http://www.csnpharm.com CSN13686 https://www.csnpharm.com/products/chloroquine-diphosphate.html
Debye Scientific Co., Ltd DB-051808 http://www.debyesci.com/cas_50-63-5.html
VWR, Part of Avantor https://www.avantorinc.com/ BT214870-100G https://us.vwr.com/store/product/16639418/chloroquine-diphosphate-98
VWR, Part of Avantor https://www.avantorinc.com/ BT214870-25G https://us.vwr.com/store/product/16639418/chloroquine-diphosphate-98
BioChemPartner http://www.biochempartner.com/ BCP31956 http://www.biochempartner.com/50-63-5-BCP31956
eNovation Chemicals D669312 https://www.enovationchem.com/ProductDetails.asp?ProductID=D669312
Sinfoo Biotech http://sinfoobiotech.com/ S061609 http://www.sinfoobiotech.com/product/1065019
MolCore BioPharmatech https://www.molcore.com/ MC556892 https://www.molcore.com/product/50-63-5
Key Organics/BIONET https://www.keyorganics.net/ DT-0015 https://www.keyorganics.net/bionet/catalog/product/view/id/1498259
Oakwood Products http://www.oakwoodchemical.com 358020 http://www.oakwoodchemical.com/ProductsList.aspx?CategoryID=-2&txtSearch=194931&ExtHyperLink=1
THE BioTek https://www.thebiotek.com/ bt-264191 https://www.thebiotek.com/product/inhibitors/bt-264191
Chem-Space.com Database https://chem-space.com CSSB00000684538 https://chem-space.com/CSSB00000684538
Accela ChemBio Inc. http://www.accelachem.com/ SY021941 http://www.accelachem.com/cn/search.html?keyword=SY021941&attname=GoodsCode
Smolecule https://www.smolecule.com/ S523535 http://www.smolecule.com/products/s523535
Alfa Chemistry https://alfa-chemistry.com AP50635-A https://reagents.alfa-chemistry.com/product/chloroquine-phosphate-cas-50-63-5-12151.html
Alfa Chemistry https://alfa-chemistry.com AP50635-B https://reagents.alfa-chemistry.com/product/chloroquine-phosphate-cas-50-63-5-12152.html
Win-Win Chemical https://www.win-winchemical.com/ 16634
3WAY PHARM INC http://www.3wpharm.com/ SWQ-00871 http://www.3wpharm.com/detail/SWQ-00871.html
Alfa Chemistry https://alfa-chemistry.com ACM50635 https://www.alfa-chemistry.com/product/chloroquine-diphosphate-salt-cas-50-63-5-1405.html
Vendor Vendor Homepage Vendor Sku API Url

Drug Master Files for chloroquine phosphate

DMF No. Status Type Submission Date Holder Subject
10472 I II 9/10/1993 ICN HUNGARY CO LTD CHLOROQUINE PHOSPHATE
12762 I II 11/12/1997 ALKALOIDA CHEMICAL CO LTD HYDROXYCHLOROQUINE SULFATE
14087 A II 4/17/1999 IPCA LABORATORIES LTD HYDROXYCHLOROQUINE SULFATE USP
14977 A II 8/1/2000 CADILA HEALTHCARE LTD HYDROXYCHLOROQUINE SULFATE USP
20692 A II 7/17/2007 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD HYDROXYCHLOROQUINE SULFATE
21115 I II 2/6/2008 WUHAN WUYAO PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG
21567 A II 4/25/2008 AMRI RENSSELAER INC HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE
23582 A II 3/25/2010 ALKALOIDA CHEMICAL CO ZRT HYDROXYCHLOROQUINE SULFATE USP
23593 I II 3/12/2010 UNIMARK REMEDIES LTD HYDROXYCHLOROQUINE SULFATE USP
25709 I II 1/9/2012 SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE (USP)
30014 A II 11/24/2015 FERMION OY HYDROXYCHLOROQUINE SULPHATE
30825 A II 8/1/2016 CHONGQING KANGLE PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP
31956 A II 9/8/2017 LAURUS LABS LTD HYDROXYCHLOROQUINE SULFATE USP
3916 I II 7/21/1980 FBA PHARMACEUTICALS INC DIV BAYCHEM CORP CHLOROQUINE DIPHOSPHATE
4693 I II 10/13/1982 SANOFI SYNTHELABO INC HYDROXYCHLOROQUINE SULFATE
6425 I II 6/11/1986 SANOFI PHARMACEUTICALS INC CHLOROQUINE BASE AND PHOSPHATE
8487 I II 3/22/1990 ABBOTT LABORATORIES HYROCHLOROQUINE SULFATE
8619 A II 6/27/1990 SCI PHARMTECH INC HYDROXYCHLOROQUINE SULFATE
9235 A II 7/2/1991 IPCA LABORATORIES LTD CHLOROQUINE PHOSPHATE USP
9490 I II 12/6/1991 SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE
DMF No. Status Type Submission Date Holder Subject

hydroxychloroquine sulfate

Finished product suppliers for hydroxychloroquine sulfate

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Accord Hlthcare HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 213342 ANDA Accord Healthcare, Inc. 16729-485-16 500 TABLET in 1 BOTTLE (16729-485-16)
Alkaloida Zrt HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 201691 ANDA A-S Medication Solutions 50090-5388-2 90 TABLET in 1 BOTTLE (50090-5388-2)
Alkaloida Zrt HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 201691 ANDA Sun Pharmaceutical Industries, Inc. 57664-761-13 500 TABLET in 1 BOTTLE (57664-761-13)
Alkaloida Zrt HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 201691 ANDA Sun Pharmaceutical Industries, Inc. 57664-761-88 100 TABLET in 1 BOTTLE (57664-761-88)
Amneal Pharms Co HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA A-S Medication Solutions 50090-4659-1 60 TABLET, FILM COATED in 1 BOTTLE (50090-4659-1)
Amneal Pharms Co HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA A-S Medication Solutions 50090-4659-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-4659-2)
Amneal Pharms Co HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA A-S Medication Solutions 50090-4659-3 12 TABLET, FILM COATED in 1 BOTTLE (50090-4659-3)
Amneal Pharms Co HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA Amneal Pharmaceuticals NY LLC 60219-1544-1 100 TABLET, FILM COATED in 1 BOTTLE (60219-1544-1)
Amneal Pharms Co HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA Amneal Pharmaceuticals NY LLC 69238-1544-1 100 TABLET, FILM COATED in 1 BOTTLE (69238-1544-1)
Amneal Pharms Co HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA Amneal Pharmaceuticals NY LLC 69238-1544-5 500 TABLET, FILM COATED in 1 BOTTLE (69238-1544-5)
Dr Reddys HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA Major Pharmaceuticals 0904-7046-06 50 BLISTER PACK in 1 CARTON (0904-7046-06) > 1 TABLET in 1 BLISTER PACK
Dr Reddys HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA Major Pharmaceuticals 0904-7046-61 100 BLISTER PACK in 1 CARTON (0904-7046-61) > 1 TABLET in 1 BLISTER PACK
Dr Reddys HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA Dr. Reddy's Laboratories Inc. 43598-721-01 100 TABLET in 1 BOTTLE (43598-721-01)
Dr Reddys HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA Dr. Reddy's Laboratories Inc. 43598-721-05 500 TABLET in 1 BOTTLE (43598-721-05)
Dr Reddys HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA AvPAK 50268-412-15 50 BLISTER PACK in 1 BOX (50268-412-15) > 1 TABLET in 1 BLISTER PACK (50268-412-11)
Havix HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 212902 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-780-01 100 TABLET in 1 BOTTLE (59746-780-01)
Havix HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 212902 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-780-05 500 TABLET in 1 BOTTLE (59746-780-05)
Ipca Labs Ltd HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040766 ANDA DOH CENTRAL PHARMACY 53808-1112-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1112-1)
Laurus Labs Ltd HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210959 ANDA Rising Pharma Holdings, Inc. 16571-687-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-687-01)
Laurus Labs Ltd HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210959 ANDA Rising Pharma Holdings, Inc. 16571-687-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-687-50)
Laurus Labs Ltd HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210959 ANDA Laurus Labs Limited 42385-927-01 100 TABLET, FILM COATED in 1 BOTTLE (42385-927-01)
Laurus Labs Ltd HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210959 ANDA Laurus Labs Limited 42385-927-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-927-05)
Mylan HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040274 ANDA Mylan Pharmaceuticals Inc. 0378-0373-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0373-01)
Mylan HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040274 ANDA Mylan Institutional Inc. 42292-011-06 50 BLISTER PACK in 1 CARTON (42292-011-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-011-01)
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Sandoz Inc 0781-1407-52 500 TABLET, FILM COATED in 1 BOTTLE (0781-1407-52)
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Sandoz Inc 0781-1407-97 100 TABLET, FILM COATED in 1 BOTTLE (0781-1407-97)
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Sandoz Inc 0781-5994-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5994-01)
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Sandoz Inc 0781-5994-05 500 TABLET, FILM COATED in 1 BOTTLE (0781-5994-05)
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Major Pharmaceuticals 0904-6884-06 50 BLISTER PACK in 1 CARTON (0904-6884-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Major Pharmaceuticals 0904-6884-61 100 BLISTER PACK in 1 CARTON (0904-6884-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA Northstar RxLLC 16714-753-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-753-01)
Sandoz HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040104 ANDA RedPharm Drug, Inc. 67296-1780-1 12 TABLET, FILM COATED in 1 BOTTLE (67296-1780-1)
Teva Pharms HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040081 ANDA Teva Pharmaceuticals USA, Inc. 0093-2401-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-2401-01)
Teva Pharms HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040081 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8374-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8374-39)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA Actavis Pharma, Inc. 0591-3041-01 100 TABLET, FILM COATED in 1 BOTTLE (0591-3041-01)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA Actavis Pharma, Inc. 0591-3041-05 500 TABLET, FILM COATED in 1 BOTTLE (0591-3041-05)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8325-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8325-39)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA A-S Medication Solutions 50090-2508-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-2508-0)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA A-S Medication Solutions 50090-2508-1 60 TABLET, FILM COATED in 1 BOTTLE (50090-2508-1)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA A-S Medication Solutions 50090-2508-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-2508-2)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA A-S Medication Solutions 50090-2508-3 12 TABLET, FILM COATED in 1 BOTTLE (50090-2508-3)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA RPK Pharmaceuticals, Inc. 53002-4850-2 20 TABLET, FILM COATED in 1 BOTTLE (53002-4850-2)
Watson Labs HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040133 ANDA RPK Pharmaceuticals, Inc. 53002-4850-6 60 TABLET, FILM COATED in 1 BOTTLE (53002-4850-6)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Northstar Rx LLC. 16714-110-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-110-01)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Cardinal Health 55154-2074-0 10 BLISTER PACK in 1 BAG (55154-2074-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA McKesson Corporation dba SKY Packaging 63739-777-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-777-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Cadila Healthcare Limited 65841-633-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-633-01)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Cadila Healthcare Limited 65841-633-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-633-05)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Cadila Healthcare Limited 65841-633-30 10 BLISTER PACK in 1 CARTON (65841-633-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA NuCare Pharmaceuticals,Inc. 68071-2332-1 100 TABLET, FILM COATED in 1 BOTTLE (68071-2332-1)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA NuCare Pharmaceuticals,Inc. 68071-4648-1 100 TABLET, FILM COATED in 1 BOTTLE (68071-4648-1)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA American Health Packaging 68084-269-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-269-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-269-11)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-096-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-096-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-096-77 100 BLISTER PACK in 1 CARTON (68382-096-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Preferred Pharmaceuticals, Inc. 68788-7747-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-7747-2)
Zydus Pharms Usa Inc HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Preferred Pharmaceuticals, Inc. 68788-7747-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7747-3)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-051-09 9000 TABLET in 1 BOTTLE (43353-051-09)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-051-53 60 TABLET in 1 BOTTLE (43353-051-53)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-051-60 90 TABLET in 1 BOTTLE (43353-051-60)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-051-80 180 TABLET in 1 BOTTLE (43353-051-80)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-3432-1 60 TABLET in 1 BOTTLE (50090-3432-1)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-3432-2 90 TABLET in 1 BOTTLE (50090-3432-2)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA Concordia Pharmaceuticals Inc. 59212-562-10 100 TABLET in 1 BOTTLE (59212-562-10)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA Concordia Pharmaceuticals Inc. 59212-562-11 100 TABLET in 1 BOTTLE (59212-562-11)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA Concordia Pharmaceuticals Inc. 59212-562-60 60 TABLET in 1 BOTTLE (59212-562-60)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-3343-1 100 TABLET in 1 BOTTLE (63629-3343-1)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-3343-2 30 TABLET in 1 BOTTLE (63629-3343-2)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-3343-3 60 TABLET in 1 BOTTLE (63629-3343-3)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-3343-4 180 TABLET in 1 BOTTLE (63629-3343-4)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-3343-5 90 TABLET in 1 BOTTLE (63629-3343-5)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-057-02 100 TABLET in 1 BOTTLE (66993-057-02)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-057-04 500 TABLET in 1 BOTTLE (66993-057-04)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA RedPharm Drug, Inc. 67296-1781-1 12 TABLET in 1 BOTTLE (67296-1781-1)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7770-1 100 TABLET in 1 BOTTLE (68788-7770-1)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7770-2 20 TABLET in 1 BOTTLE (68788-7770-2)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7770-3 30 TABLET in 1 BOTTLE (68788-7770-3)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7770-4 24 TABLET in 1 BOTTLE (68788-7770-4)
Concordia PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7770-8 8 TABLET in 1 BOTTLE (68788-7770-8)
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

API manufacturers for hydroxychloroquine sulfate

Vendor Vendor Homepage Vendor Sku API Url
NIH Clinical Collection http://www.nihclinicalcollection.com/ SAM001246735
NovoSeek http://www.novoseek.com 12947 http://www.novoseek.com/AccessPoint.action?corpus=MEDLINE&externalDBId=cid%3d12947&DBName=pubchem&actionName=search&bioType=drug
MolPort https://www.molport.com MolPort-003-666-519 https://www.molport.com/shop/molecule-link/MolPort-003-666-519
ABI Chem http://www.abichem.com AC1L20PB
TCI (Tokyo Chemical Industry) http://www.tcichemicals.com/en/us/ H1306 http://www.tcichemicals.com/eshop/en/us/commodity/H1306/index.html
ChemMol http://chemmol.com/suppliers/ChemMol/494/1/ 49414910 http://www.chemmol.com/chemmol/49414910.html
Oakwood Products http://www.oakwoodchemical.com 079411 http://www.oakwoodchemical.com/ProductsList.aspx?CategoryID=-2&txtSearch=64585&ExtHyperLink=1
Ark Pharm, Inc. http://www.arkpharminc.com/ AK-72909 http://www.arkpharminc.com/products/747-36-4.html
CAPOT http://www.capotchem.com/ PubChem15393 http://www.capotchem.com/en/15393.htm
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS015897337 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS015897337
CAPOT http://www.capotchem.com 15393 http://www.capotchem.com/en/15393.htm
Anward http://www.anward.com ANW-43969 http://www.anward.com/pro_result/24547
Chembase.cn http://www.chembase.cn 70510 http://www.chembase.cn/molecule-70510.html
AK Scientific, Inc. (AKSCI) http://www.aksci.com M567 http://www.aksci.com/item_detail.php?cat=M567
ChemTik http://www.chemtik.com/ CTK8B4131 http://www.chemtik.com/pro_result/814131/
Rosewachem http://www.rosewachem.com RW2760
Finetech Industry Limited http://www.finetechnology-ind.com FT-0603511 http://www.finetechnology-ind.com/prod/detail/pub/747-36-4.html
Mcule https://mcule.com MCULE-4122662001 https://mcule.com/MCULE-4122662001/
BerrChem http://www.berrchem.com/ BR-72909
Aurum Pharmatech LLC http://www.Aurumpharmatech.com S-2011 http://www.Aurumpharmatech.com/Product/ProductDetails/S_2011
Key Organics/BIONET https://www.keyorganics.net/bionet/ KS-5311 http://www.keyorganics.net/bionet/catalog/product/view/id/358527
Alsachim http://www.alsachim.com 3314 http://www.alsachim.com/product-C4600-glo.bal-view.html
Tractus http://www.tractuschem.com/ TR-024132 http://www.tractuschem.com/productshow/TR-024132.html
Assembly Blocks Pvt. Ltd. http://www.assemblyblocks.com AB0015282
AN PharmaTech http://www.anpharma.net AN-22118
ChemMol http://chemmol.com/ 99139950 http://www.chemmol.com/chemmol/99139950.html
4C Pharma Scientific Inc 4CH-007360 http://www.4cpharmainc.com/product/225040.html
Syntree http://www.syntree.com/ ST24030764 http://www.syntree.com/747-36-4
Axon Medchem https://www.axonmedchem.com/product/2432 2432
Race Chemical http://www.racechemical.com RV022504186
AHH Chemical co.,ltd http://www.ahhchemical.com API-1742 http://www.ahhchemical.com/product/API-1742.html
Molepedia http://www.molepedia.com/ M92272303P http://www.molepedia.com/
Pure chemistry http://www.chemreagents.com/ 80010782 http://www.chemreagents.com/Product/Product.asp?ProductID=80010782
BOC Sciences https://www.bocsci.com/ 747-36-4 https://www.bocsci.com/hydroxychloroquine-sulfate-cas-747-36-4-item-76365.html
Biosynth Carbosynth http://www.biosynth.com/ W-104413 https://www.biosynth.com/en/products/life-science/other-biochemicals/products/W-104413.html
OXCHEM CORPORATION http://www.ox-chem.com AX8134190 http://www.ox-chem.com/pc/en/product_item.aspx?ID=AX8134190
BePharm Ltd. http://www.bepharm.com B134190 http://www.bepharm.com/web/en/product/pro_item.aspx?id=B134190
AK Scientific, Inc. (AKSCI) http://www.aksci.com J10260 http://www.aksci.com/item_detail.php?cat=J10260
AEchem Scientific Corp., USA http://www.aechemsc.com AE020055 http://www.aechemsc.com/info_products/AE020055.php
Glentham Life Sciences Ltd. http://www.glentham.com GK2606 http://www.glentham.com/products/product/GK2606/
TargetMol (Target Molecule Corp.) http://www.targetmol.com/ T0951 http://www.targetmol.com/compound/Hydroxychloroquine-sulfate
Changzhou Highassay Chemical Co., Ltd http://www.highassay.com/profile/aboutus.html my_sub2143
abcr GmbH http://www.abcr.de/en/homepage/ AB331780 http://www.abcr.de/shop/en/AB331780
Tocris Bioscience https://www.tocris.com 5648 https://www.tocris.com/products/hydroxychloroquine-sulfate_5648
iChemical Technology USA Inc https://www.ichemical.com EBD14908 http://www.ichemical.com/chemicals/cas-747-36-4
Pi Chemicals http://www.pipharm.com PI-10791 http://www.pipharm.com/catalog/PI-10791.html
Sigma-Aldrich http://www.sigmaaldrich.com 1327000_USP https://www.sigmaaldrich.com/catalog/product/usp/1327000?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com 90527_SIAL https://www.sigmaaldrich.com/catalog/product/sial/90527?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com H0915_SIGMA https://www.sigmaaldrich.com/catalog/product/sigma/h0915?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com PHR1782_SIAL https://www.sigmaaldrich.com/catalog/product/sial/phr1782?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Enamine http://www.enamine.net Z1551900864 https://www.enaminestore.com/catalog/Z1551900864
Achemo Scientific Limited https://www.achemo.com AC-13182 http://www.achemo.com/search/?Keyword= 747-36-4
LGC Standards https://www.lgcstandards.com LGCAMP0764.00-01 https://www.lgcstandards.com/US/en/p/LGCAMP0764.00-01
LGC Standards https://www.lgcstandards.com LGCFOR0764.00 https://www.lgcstandards.com/US/en/p/LGCFOR0764.00
Activate Scientific https://activate-scientific.com AS34770 https://shop.activate-scientific.com/code/AS34770
BOC Sciences https://www.bocsci.com/ 1216432-56-2 https://www.bocsci.com/hydroxychloroquine-d4-sulfate-cas-1216432-56-2-item-261837.html
OChem https://www.ocheminc.com 3567 http://www.ocheminc.com/index.php?act=psearch&pid=747H364
Wubei-Biochem http://www.wubei-biochem.com/ WB443000ST http://wubei-biochem.com/product/512292
King Scientific http://www.kingscientific.com KS-00000GEU http://www.kingscientific.com/goods/Goods/detail?id=KS-00000GEU
LabNetwork, a WuXi AppTec Company https://www.LabNetwork.com LN00176750 https://labnetwork.com/frontend-app/p/#!/moleculedetails/LN00176750
Finetech Industry Limited http://www.finetechnology-ind.com FT-0669460 http://www.finetechnology-ind.com/prod/detail/pub/1216432-56-2.html
Selleck Chemicals http://www.selleckchem.com/ S4430 http://www.selleckchem.com/products/hydroxychloroquine-sulfate.html
MedChemexpress MCE https://www.medchemexpress.com/ HY-B1370 https://www.medchemexpress.com/Hydroxychloroquine_sulfate.html
AbaChemScene https://www.chemscene.com/ CS-8017 http://www.chemscene.com/747-36-4.html
Chemieliva Pharmaceutical Co., Ltd http://www.chemieliva.com PBCM0808933
DC Chemicals https://www.dcchemicals.com DCAPI1570 http://www.dcchemicals.com/product_show-Hydroxychloroquine Sulphate.html
Chemenu Inc. http://www.chemenu.com/ CM110469 http://www.chemenu.com/products/CM110469
MuseChem https://www.musechem.com A000121 https://www.musechem.com/product/A000121.html
China MainChem Co., Ltd https://www.mainchem.com 747-36-4 https://www.mainchem.com/product/hydroxychloroquine-sulfate/
Combi-Blocks https://www.combi-blocks.com QA-8047 http://www.combi-blocks.com/cgi-bin/find.cgi?QA-8047
AA BLOCKS http://www.aablocks.com AA0059MB http://www.aablocks.com/goods/Goods/detail?id=AA0059MB
Parchem https://www.parchem.com 88021 https://www.parchem.com/chemical-supplier-distributor/Hydroxychloroquine-Sulphate-088021.aspx
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B2-0769 http://www.3bsc.com/index/pro_info.php?id=20125
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B1-00319 http://www.3bsc.com/index/pro_info.php?id=20531
BioChemPartner http://www.biochempartner.com/ BCP12823 http://www.biochempartner.com/747-36-4-BCP12823
Uchem Meditech http://www.uchemmed.com/ U3731 http://www.uchemmed.com/2120-Hydroxychloroquine%20Sulfate.html
Hairui Chemical http://www.hairuichem.com/en/ HR136071 http://www.hairuichem.com/en/product/747-36-4.html
eNovation Chemicals D592443 http://www.enovationchem.com/productDetails.asp?productID=D592443
Ambeed https://www.ambeed.com/ A105779 https://www.ambeed.com/products/747-36-4.html
Acros Organics https://www.fishersci.com AC263010250 https://www.fishersci.com/shop/products/hydroxychloroquine-sulfate-98-acros-organics-1/AC263010250
Acros Organics https://www.fishersci.com AC263011000 https://www.fishersci.com/shop/products/hydroxychloroquine-sulfate-98-acros-organics/AC263011000
Synblock Inc http://www.synblock.com/ SB19140 http://www.synblock.com/product/747-36-4.html
Achemtek http://achemtek.com/ 0104-015096 http://www.achemtek.com/747-36-4
BioCrick https://www.biocrick.com/ BCC5560 http://www.biocrick.com/Hydroxychloroquine-Sulfate-BCC5560.html
Norris Pharm http://www.norris-pharm.com/ NSTH-D04352
eNovation Chemicals D630746 https://www.enovationchem.com/ProductDetails.asp?ProductID=D630746
VWR, Part of Avantor https://www.avantorinc.com/ 200012-708 https://us.vwr.com/store/product/18601037/hydroxychloroquine-sulfate-98
VWR, Part of Avantor https://www.avantorinc.com/ 101095-170 https://us.vwr.com/store/catalog/product.jsp?catalog_number=101095-170
CSNpharm http://www.csnpharm.com CSN11173 https://www.csnpharm.com/products/hydroxychloroquine-sulfate.html
Debye Scientific Co., Ltd DB-055904 http://www.debyesci.com/cas_747-36-4.html
LGC Standards https://www.lgcstandards.com MM0764.00-0250 https://www.lgcstandards.com/US/en/p/MM0764.00-0250
Clearsynth https://www.clearsynth.com/ CS-EB-01063 https://www.clearsynth.com/en/CSEB01063.html
Clearsynth https://www.clearsynth.com/ CS-ER-01055 https://www.clearsynth.com/en/CSER01055.html
eNovation Chemicals D673841 https://www.enovationchem.com/ProductDetails.asp?ProductID=D673841
MolCore BioPharmatech https://www.molcore.com/ MC461390 https://www.molcore.com/product/747-36-4
Aaron Chemicals LLC http://www.aaronchem.com/ AR005AE3 http://www.aaronchem.com/747-36-4
Matrix Scientific https://www.matrixscientific.com 076061 https://www.matrixscientific.com/076061.html
Lan Pharmatech http://www.lanpharmatech.com LAN-B10815 http://www.lanpharmatech.com/product-9?_keywords=LAN-B10815
Alfa Chemistry https://www.alfa-chemistry.com/ ACM747364 https://materials.alfachemic.com/product/hydroxychloroquine-sulfate-98-cas-747-36-4-325404.html
THE BioTek https://www.thebiotek.com/ bt-271274 https://www.thebiotek.com/product/inhibitors/bt-271274
Chem-Space.com Database https://chem-space.com CSSB00016988933 https://chem-space.com/CSSB00016988933
Alfa Chemistry https://alfa-chemistry.com AP747364-A https://reagents.alfa-chemistry.com/product/hydroxycloroquine-sulfate-cas-747-36-4-15932.html
Alfa Chemistry https://alfa-chemistry.com AP747364-B https://reagents.alfa-chemistry.com/product/hydroxychloroquine-sulfate-cas-747-36-4-15933.html
Alfa Chemistry https://alfa-chemistry.com AP747364 https://reagents.alfa-chemistry.com/product/hydroxychloroquine-sulfate-cas-747-36-4-15931.html
3WAY PHARM INC http://www.3wpharm.com/ SWOT-86044 http://www.3wpharm.com/detail/SWOT-86044.html
Vendor Vendor Homepage Vendor Sku API Url

Drug Master Files for hydroxychloroquine sulfate

DMF No. Status Type Submission Date Holder Subject
12762 I II 11/12/1997 ALKALOIDA CHEMICAL CO LTD HYDROXYCHLOROQUINE SULFATE
14087 A II 4/17/1999 IPCA LABORATORIES LTD HYDROXYCHLOROQUINE SULFATE USP
14977 A II 8/1/2000 CADILA HEALTHCARE LTD HYDROXYCHLOROQUINE SULFATE USP
20692 A II 7/17/2007 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD HYDROXYCHLOROQUINE SULFATE
21115 I II 2/6/2008 WUHAN WUYAO PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG
21567 A II 4/25/2008 AMRI RENSSELAER INC HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE
23582 A II 3/25/2010 ALKALOIDA CHEMICAL CO ZRT HYDROXYCHLOROQUINE SULFATE USP
23593 I II 3/12/2010 UNIMARK REMEDIES LTD HYDROXYCHLOROQUINE SULFATE USP
25709 I II 1/9/2012 SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE (USP)
30014 A II 11/24/2015 FERMION OY HYDROXYCHLOROQUINE SULPHATE
30825 A II 8/1/2016 CHONGQING KANGLE PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE USP
31956 A II 9/8/2017 LAURUS LABS LTD HYDROXYCHLOROQUINE SULFATE USP
4693 I II 10/13/1982 SANOFI SYNTHELABO INC HYDROXYCHLOROQUINE SULFATE
8619 A II 6/27/1990 SCI PHARMTECH INC HYDROXYCHLOROQUINE SULFATE
9490 I II 12/6/1991 SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD HYDROXYCHLOROQUINE SULFATE
DMF No. Status Type Submission Date Holder Subject

ivermectin

Finished product suppliers for ivermectin

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Teva Pharms Usa IVERMECTIN ivermectin CREAM;TOPICAL 210019 ANDA Actavis Pharma, Inc. 0591-4052-89 1 TUBE in 1 CARTON (0591-4052-89) > 45 g in 1 TUBE
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823-00 2 g in 1 TUBE (0299-3823-00)
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823-02 1 TUBE in 1 BLISTER PACK (0299-3823-02) > 2 g in 1 TUBE
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823-30 1 TUBE in 1 CARTON (0299-3823-30) > 30 g in 1 TUBE
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823-45 1 TUBE in 1 CARTON (0299-3823-45) > 45 g in 1 TUBE
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823-60 1 TUBE in 1 CARTON (0299-3823-60) > 60 g in 1 TUBE
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-948-48 1 TUBE in 1 CARTON (66993-948-48) > 45 g in 1 TUBE
Taro IVERMECTIN ivermectin LOTION;TOPICAL 210720 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4211-8 1 TUBE in 1 CARTON (51672-4211-8) > 117 g in 1 TUBE
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154 ANDA Edenbridge Pharmaceuticals, LLC 42799-806-01 2 BLISTER PACK in 1 CARTON (42799-806-01) > 10 TABLET in 1 BLISTER PACK
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154 ANDA Bryant Ranch Prepack 63629-7275-1 2 TABLET in 1 BOTTLE (63629-7275-1)
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154 ANDA Bryant Ranch Prepack 63629-7275-2 30 TABLET in 1 BOTTLE (63629-7275-2)
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154 ANDA Bryant Ranch Prepack 63629-7275-3 4 TABLET in 1 BOTTLE (63629-7275-3)
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154 ANDA Bryant Ranch Prepack 63629-7275-4 10 TABLET in 1 BOTTLE (63629-7275-4)
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154 ANDA NuCare Pharmaceuticals,Inc. 68071-2242-3 2 BLISTER PACK in 1 CARTON (68071-2242-3) > 10 TABLET in 1 BLISTER PACK
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742 NDA Merck Sharp & Dohme Corp. 0006-0032-20 2 BLISTER PACK in 1 CARTON (0006-0032-20) > 10 TABLET in 1 BLISTER PACK
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

API manufacturers for ivermectin

Vendor Vendor Homepage Vendor Sku API Url
Sigma-Aldrich http://www.sigmaaldrich.com I8898_SIGMA https://www.sigmaaldrich.com/catalog/product/sigma/i8898?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
MolPort https://www.molport.com MolPort-006-394-715 https://www.molport.com/shop/molecule-link/MolPort-006-394-715
Chembase.cn http://www.chembase.cn 72880 http://www.chembase.cn/molecule-72880.html
AK Scientific, Inc. (AKSCI) http://www.aksci.com K185 http://www.aksci.com/item_detail.php?cat=K185
Wutech http://www.rennotech.com RL04692 http://www.rennotech.com/product_show.asp?id=4941
ChemMol http://chemmol.com/ 99154928 http://www.chemmol.com/chemmol/99154928.html
ChemMol http://chemmol.com/ 99155065 http://www.chemmol.com/chemmol/99155065.html
AvaChem Scientific http://www.avachem.com/productSearch.asp?3002 71827-03-7
AvaChem Scientific http://www.avachem.com/productSearch.asp?3002 3002 http://www.avachem.com/productSearch.asp?3002
AHH Chemical co.,ltd http://www.ahhchemical.com API-1387 http://www.ahhchemical.com/product/API-1387.html
AHH Chemical co.,ltd http://www.ahhchemical.com MT-01102 http://www.ahhchemical.com/product/MT-01102.html
Alsachim http://www.alsachim.com 4717 http://www.alsachim.com/product-C6065-glo.bal-view.html
Biosynth Carbosynth http://www.biosynth.com/ Q-201262 https://www.biosynth.com/en/products/life-science/culture-media-additives/products/Q-201262.html
AK Scientific, Inc. (AKSCI) http://www.aksci.com J10179 http://www.aksci.com/item_detail.php?cat=J10179
Aurora Fine Chemicals LLC http://www.aurorafinechemicals.com K14.717.676 http://online.aurorafinechemicals.com/info?ID=K14.717.676
Aurora Fine Chemicals LLC http://www.aurorafinechemicals.com A17.912.759 http://online.aurorafinechemicals.com/info?ID=A17.912.759
Glentham Life Sciences Ltd. http://www.glentham.com GA9725 http://www.glentham.com/products/product/GA9725/
TargetMol (Target Molecule Corp.) http://www.targetmol.com/ T1131 http://www.targetmol.com/compound/Ivermectin
BOC Sciences https://www.bocsci.com/ 70288-86-7 https://www.bocsci.com/ivermectin-d2-cas-70288-86-7-unlabeled-item-473483.html
Changzhou Highassay Chemical Co., Ltd http://www.highassay.com/profile/aboutus.html my_sub2235
Yuhao Chemical http://www.chemyuhao.com CJ3102 http://www.chemyuhao.com/70288-86-7.html
ChemShuttle https://www.chemshuttle.com 141029 http://www.chemshuttle.com/catalogsearch/result/?q=70288-86-7&cat=
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS027470116 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS027470116
Sigma-Aldrich http://www.sigmaaldrich.com 1354309_USP https://www.sigmaaldrich.com/catalog/product/usp/1354309?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com I8000010_SIAL https://www.sigmaaldrich.com/catalog/product/sial/i8000010?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com PHR1380_SIAL https://www.sigmaaldrich.com/catalog/product/sial/phr1380?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
ZINC http://zinc15.docking.org ZINC238808778 http://zinc.docking.org/substances/ZINC238808778/
ZINC http://zinc15.docking.org ZINC252286706 http://zinc.docking.org/substances/ZINC252286706/
Acorn PharmaTech Product List http://www.acornpharmatech.com ACN-043276 http://www.acornpharmatech.com/
BOC Sciences https://www.bocsci.com/ 70161-11-4 https://www.bocsci.com/ivermectin-b1a-cas-70161-11-4-item-209725.html
OChem https://www.ocheminc.com 3749 http://www.ocheminc.com/index.php?act=psearch&pid=288I867
Selleck Chemicals http://www.selleckchem.com/ S1351 http://www.selleckchem.com/products/Ivermectin.html
Chemieliva Pharmaceutical Co., Ltd http://www.chemieliva.com PBCM0788165
Key Organics/BIONET https://www.keyorganics.net/bionet/ AS-14167 http://www.keyorganics.net/bionet/catalog/product/view/id/750086
iChemical Technology USA Inc https://www.ichemical.com EBD3068789 http://www.ichemical.com/products/70288-86-7.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
iChemical Technology USA Inc https://www.ichemical.com EBD3686125 http://www.ichemical.com/products/71827-03-7.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
MuseChem https://www.musechem.com R004886 https://www.musechem.com/product/R004886.html
MuseChem https://www.musechem.com R029475 https://www.musechem.com/product/R029475.html
Combi-Blocks https://www.combi-blocks.com QC-5964 http://www.combi-blocks.com/cgi-bin/find.cgi?QC-5964
Hairui Chemical http://www.hairuichem.com/en/ HR125996 http://www.hairuichem.com/en/product/70288-86-7.html
eNovation Chemicals D389079 https://www.enovationchem.com/ProductDetails.asp?ProductID=D389079
Sigma-Aldrich http://www.sigmaaldrich.com BP864_SIAL https://www.sigmaaldrich.com/catalog/product/sial/bp864?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
VladaChem https://www.vladachem.com VL276184-100MG https://www.vladachem.com/product.php?products=70288-86-7
Achemtek http://achemtek.com/ 0104-007352 http://www.achemtek.com/70288-86-7
Achemtek http://achemtek.com/ 1ST20393 http://achemtek.com/70288-86-7-4
BioCrick https://www.biocrick.com/ BCC9005 http://www.biocrick.com/Ivermectin-B1a-BCC9005.html
Hello Bio https://www.hellobio.com HB1958 https://www.hellobio.com/ivermectin.html
eNovation Chemicals D675789 https://www.enovationchem.com/ProductDetails.asp?ProductID=D675789
MedChemexpress MCE https://www.medchemexpress.com/ HY-126937 https://www.medchemexpress.com/ivermectin-b1a.html
AbaChemScene https://www.chemscene.com/ CS-0108408 http://www.chemscene.com/71827-03-7.html
Chem-Space.com Database https://chem-space.com CSSB02125552454 https://chem-space.com/CSSB02125552454
Alfa Chemistry https://alfa-chemistry.com AP70288867-A https://reagents.alfa-chemistry.com/product/ivermectin-cas-70288-86-7-15336.html
Alfa Chemistry https://alfa-chemistry.com AP70288867-B https://reagents.alfa-chemistry.com/product/ivermectin-cas-70288-86-7-15337.html
Vendor Vendor Homepage Vendor Sku API Url

Drug Master Files for ivermectin

DMF No. Status Type Submission Date Holder Subject
12755 I II 11/21/1997 HAIMEN PHARMACEUTICAL FACTORY IVERMECTIN, NON-STERILE BULK DRUG
13037 I II 6/15/1998 SHANGHAI TONGREN PHARMACEUTICAL CO LTD IVERMECTIN
17673 I II 7/18/2004 DELTA TECH LTD IVERMECTIN
21395 A II 3/5/2008 HOVIONE PHARMASCIENCE LTD IVERMECTIN USP
21624 A II 5/8/2008 ZHEJIANG HISUN PHARMACEUTICAL CO LTD IVERMECTIN USP
DMF No. Status Type Submission Date Holder Subject

levofloxacin

Finished product suppliers for levofloxacin

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Akorn LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 091644 ANDA Akorn, Inc. 17478-107-20 1 VIAL in 1 CARTON (17478-107-20) > 20 mL in 1 VIAL
Akorn LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 091644 ANDA Akorn, Inc. 17478-107-30 1 VIAL in 1 CARTON (17478-107-30) > 30 mL in 1 VIAL
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-156-20 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) > 20 mL in 1 VIAL, SINGLE-USE
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-157-30 1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) > 30 mL in 1 VIAL, SINGLE-USE
Baxter Hlthcare Corp LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 091436 ANDA Baxter Healthcare Corporation 36000-045-01 20 mL in 1 VIAL, SINGLE-USE (36000-045-01)
Gland Pharma Ltd LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205540 ANDA Gland Pharma Limited 68083-394-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) > 20 mL in 1 VIAL, SINGLE-DOSE
Gland Pharma Ltd LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205540 ANDA Gland Pharma Limited 68083-395-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-395-01) > 30 mL in 1 VIAL, SINGLE-DOSE
Zydus Pharms LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205968 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-989-20 20 mL in 1 VIAL (68382-989-20)
Zydus Pharms LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205968 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-989-30 30 mL in 1 VIAL (68382-989-30)
Zydus Pharms LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205968 ANDA Cadila Healthcare Limited 70771-1079-2 20 mL in 1 VIAL (70771-1079-2)
Zydus Pharms LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205968 ANDA Cadila Healthcare Limited 70771-1079-3 30 mL in 1 VIAL (70771-1079-3)
Aurobindo Pharma Ltd LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206919 ANDA AuroMedics Pharma LLC 55150-243-46 24 POUCH in 1 CARTON (55150-243-46) > 1 BAG in 1 POUCH > 50 mL in 1 BAG
Aurobindo Pharma Ltd LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206919 ANDA AuroMedics Pharma LLC 55150-244-47 24 POUCH in 1 CARTON (55150-244-47) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
Aurobindo Pharma Ltd LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206919 ANDA AuroMedics Pharma LLC 55150-245-52 24 POUCH in 1 CARTON (55150-245-52) > 1 BAG in 1 POUCH > 150 mL in 1 BAG
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397 ANDA Baxter Healthcare Corporation 36000-046-24 50 mL in 1 BAG (36000-046-24)
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397 ANDA Baxter Healthcare Corporation 36000-047-24 100 mL in 1 BAG (36000-047-24)
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397 ANDA Baxter Healthcare Corporation 36000-048-24 150 mL in 1 BAG (36000-048-24)
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397 ANDA Baxter Healthcare Corporation 36000-294-24 50 mL in 1 BAG (36000-294-24)
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397 ANDA Baxter Healthcare Corporation 36000-295-24 100 mL in 1 BAG (36000-295-24)
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397 ANDA Baxter Healthcare Corporation 36000-296-24 150 mL in 1 BAG (36000-296-24)
Fresenius Kabi Usa LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355-50 1 BAG in 1 POUCH (63323-355-50) > 50 mL in 1 BAG
Fresenius Kabi Usa LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355-60 1 BAG in 1 POUCH (63323-355-60) > 150 mL in 1 BAG
Fresenius Kabi Usa LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355-65 1 BAG in 1 POUCH (63323-355-65) > 100 mL in 1 BAG
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA Hikma Pharmaceuticals USA Inc. 0143-9315-24 24 BAG in 1 CARTON (0143-9315-24) > 50 mL in 1 BAG (0143-9315-01)
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA Hikma Pharmaceuticals USA Inc. 0143-9316-24 24 BAG in 1 CARTON (0143-9316-24) > 100 mL in 1 BAG (0143-9316-01)
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA Hikma Pharmaceuticals USA Inc. 0143-9317-24 24 BAG in 1 CARTON (0143-9317-24) > 150 mL in 1 BAG (0143-9317-01)
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA Hikma Pharmaceuticals USA Inc. 0143-9720-24 24 BAG in 1 CARTON (0143-9720-24) > 150 mL in 1 BAG (0143-9720-01)
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA Hikma Pharmaceuticals USA Inc. 0143-9721-24 24 BAG in 1 CARTON (0143-9721-24) > 100 mL in 1 BAG (0143-9721-01)
Hikma Farmaceutica LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA Hikma Pharmaceuticals USA Inc. 0143-9722-24 24 BAG in 1 CARTON (0143-9722-24) > 50 mL in 1 BAG (0143-9722-01)
Hospira Inc LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 078579 ANDA Hospira, Inc. 0409-0528-15 24 POUCH in 1 CASE (0409-0528-15) > 1 BAG in 1 POUCH > 50 mL in 1 BAG (0409-0528-13)
Hospira Inc LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 078579 ANDA Hospira, Inc. 0409-0528-25 24 POUCH in 1 CASE (0409-0528-25) > 1 BAG in 1 POUCH > 100 mL in 1 BAG (0409-0528-23)
Hospira Inc LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 078579 ANDA Hospira, Inc. 0409-0528-35 24 POUCH in 1 CASE (0409-0528-35) > 1 BAG in 1 POUCH > 150 mL in 1 BAG (0409-0528-31)
Inforlife LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 090343 ANDA Sagent Pharmaceuticals 25021-132-81 24 POUCH in 1 CARTON (25021-132-81) > 1 BAG in 1 POUCH > 50 mL in 1 BAG
Inforlife LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 090343 ANDA Sagent Pharmaceuticals 25021-132-82 24 POUCH in 1 CARTON (25021-132-82) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
Inforlife LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 090343 ANDA Sagent Pharmaceuticals 25021-132-83 24 POUCH in 1 CARTON (25021-132-83) > 1 BAG in 1 POUCH > 150 mL in 1 BAG
Inforlife LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 090343 ANDA WG Critical Care, LLC 44567-435-24 24 POUCH in 1 CARTON (44567-435-24) > 1 BAG in 1 POUCH > 50 mL in 1 BAG
Inforlife LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 090343 ANDA WG Critical Care, LLC 44567-436-24 24 POUCH in 1 CARTON (44567-436-24) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
Inforlife LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 090343 ANDA WG Critical Care, LLC 44567-437-24 24 POUCH in 1 CARTON (44567-437-24) > 1 BAG in 1 POUCH > 150 mL in 1 BAG
Akorn LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 090268 ANDA Akorn Inc. 17478-106-10 1 BOTTLE, DROPPER in 1 CARTON (17478-106-10) > 5 mL in 1 BOTTLE, DROPPER
Micro Labs Ltd India LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 205600 ANDA Micro Labs Limited 42571-168-25 1 BOTTLE in 1 CARTON (42571-168-25) > 5 mL in 1 BOTTLE
Micro Labs Ltd India LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 205600 ANDA BPI LABS LLC 54288-140-01 1 CARTON in 1 CARTON (54288-140-01) > 5 mL in 1 CARTON
Rising LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 077700 ANDA Rising Pharmaceuticals, Inc. 16571-150-50 48 BOTTLE in 1 CASE (16571-150-50) > 5 mL in 1 BOTTLE
Akorn LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286-04 1 BOTTLE in 1 CARTON (50383-286-04) > 100 mL in 1 BOTTLE
Akorn LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286-08 1 BOTTLE in 1 CARTON (50383-286-08) > 200 mL in 1 BOTTLE
Akorn LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286-11 4 TRAY in 1 CASE (50383-286-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-286-10)
Akorn LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286-16 1 BOTTLE in 1 CARTON (50383-286-16) > 480 mL in 1 BOTTLE
Akorn LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286-21 4 TRAY in 1 CASE (50383-286-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-286-20)
Lannett Co Inc LEVOFLOXACIN levofloxacin SOLUTION;ORAL 205222 ANDA Pharmaceutical Associates, Inc. 0121-0872-20 2 CASE in 1 CASE (0121-0872-20) > 4 TRAY in 1 CASE (0121-0872-40) > 10 CUP in 1 TRAY (0121-0872-10) > 10 mL in 1 CUP
Lannett Co Inc LEVOFLOXACIN levofloxacin SOLUTION;ORAL 205222 ANDA Lannett Company, Inc. 0527-1948-66 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) > 100 mL in 1 BOTTLE, PLASTIC
Lannett Co Inc LEVOFLOXACIN levofloxacin SOLUTION;ORAL 205222 ANDA Lannett Company, Inc. 0527-1948-68 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) > 200 mL in 1 BOTTLE, PLASTIC
Lannett Co Inc LEVOFLOXACIN levofloxacin SOLUTION;ORAL 205222 ANDA Lannett Company, Inc. 0527-1948-70 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) > 480 mL in 1 BOTTLE, PLASTIC
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-457-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-457-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-457-05 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-05)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-457-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-07)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-457-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-10)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-459-05 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-05)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-459-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-07)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-459-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-10)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA PD-Rx Pharmaceuticals, Inc. 43063-459-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-20)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA A-S Medication Solutions 50090-1228-0 5 TABLET, FILM COATED in 1 BOTTLE (50090-1228-0)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA A-S Medication Solutions 50090-1228-1 7 TABLET, FILM COATED in 1 BOTTLE (50090-1228-1)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA A-S Medication Solutions 50090-1228-2 10 TABLET, FILM COATED in 1 BOTTLE (50090-1228-2)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA ACETRIS HEALTH, LLC 52343-119-50 50 TABLET, FILM COATED in 1 BOTTLE (52343-119-50)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA ACETRIS HEALTH, LLC 52343-120-50 50 TABLET, FILM COATED in 1 BOTTLE (52343-120-50)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA ACETRIS HEALTH, LLC 52343-121-20 20 TABLET, FILM COATED in 1 BOTTLE (52343-121-20)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RPK Pharmaceuticals, Inc. 53002-2350-1 10 TABLET, FILM COATED in 1 BOTTLE (53002-2350-1)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RPK Pharmaceuticals, Inc. 53002-2350-3 3 TABLET, FILM COATED in 1 BOTTLE (53002-2350-3)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RPK Pharmaceuticals, Inc. 53002-2350-5 5 TABLET, FILM COATED in 1 BOTTLE (53002-2350-5)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RPK Pharmaceuticals, Inc. 53002-2350-7 7 TABLET, FILM COATED in 1 BOTTLE (53002-2350-7)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RPK Pharmaceuticals, Inc. 53002-2350-9 14 TABLET, FILM COATED in 1 BOTTLE (53002-2350-9)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA DIRECT RX 61919-987-10 10 TABLET, FILM COATED in 1 BOTTLE (61919-987-10)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-536-10 10 BLISTER PACK in 1 CARTON (65862-536-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-536-50 50 TABLET, FILM COATED in 1 BOTTLE (65862-536-50)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-536-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-536-99)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-537-10 10 BLISTER PACK in 1 CARTON (65862-537-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-537-50 50 TABLET, FILM COATED in 1 BOTTLE (65862-537-50)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-537-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-537-99)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-538-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-538-05)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-538-10 10 BLISTER PACK in 1 CARTON (65862-538-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA Aurobindo Pharma Limited 65862-538-20 20 TABLET, FILM COATED in 1 BOTTLE (65862-538-20)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RedPharm Drug, Inc. 67296-0897-1 7 TABLET, FILM COATED in 1 BOTTLE (67296-0897-1)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RedPharm Drug, Inc. 67296-0897-2 10 TABLET, FILM COATED in 1 BOTTLE (67296-0897-2)
Aurobindo Pharma Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 201043 ANDA RedPharm Drug, Inc. 67296-0897-5 5 TABLET, FILM COATED in 1 BOTTLE (67296-0897-5)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA DIRECT RX 61919-440-14 14 TABLET in 1 BOTTLE (61919-440-14)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-384-05 5 TABLET in 1 BOTTLE (63187-384-05)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-384-07 7 TABLET in 1 BOTTLE (63187-384-07)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-384-10 10 TABLET in 1 BOTTLE (63187-384-10)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-384-14 14 TABLET in 1 BOTTLE (63187-384-14)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-384-20 20 TABLET in 1 BOTTLE (63187-384-20)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-925-05 5 TABLET in 1 BOTTLE (63187-925-05)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-925-07 7 TABLET in 1 BOTTLE (63187-925-07)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-925-10 10 TABLET in 1 BOTTLE (63187-925-10)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-925-14 14 TABLET in 1 BOTTLE (63187-925-14)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-925-21 21 TABLET in 1 BOTTLE (63187-925-21)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-925-28 28 TABLET in 1 BOTTLE (63187-925-28)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Bryant Ranch Prepack 63629-7681-1 10 TABLET in 1 BOTTLE (63629-7681-1)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Bryant Ranch Prepack 63629-7681-2 14 TABLET in 1 BOTTLE (63629-7681-2)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA RedPharm Drug, Inc. 67296-1351-5 5 TABLET in 1 BOTTLE (67296-1351-5)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA RedPharm Drug, Inc. 67296-1351-7 7 TABLET in 1 BOTTLE (67296-1351-7)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA RedPharm Drug 67296-1535-3 3 TABLET in 1 BOTTLE (67296-1535-3)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA RedPharm Drug, Inc. 67296-1546-1 10 TABLET in 1 BOTTLE (67296-1546-1)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA RedPharm Drug, Inc. 67296-1546-5 5 TABLET in 1 BOTTLE (67296-1546-5)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA RedPharm Drug, Inc. 67296-1546-7 7 TABLET in 1 BOTTLE (67296-1546-7)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Cipla USA Inc. 69097-282-07 100 TABLET in 1 BOTTLE (69097-282-07)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Cipla USA Inc. 69097-282-70 50 TABLET in 1 BOTTLE (69097-282-70)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Cipla USA Inc. 69097-287-07 100 TABLET in 1 BOTTLE (69097-287-07)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Cipla USA Inc. 69097-287-81 20 TABLET in 1 BOTTLE (69097-287-81)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Cipla USA Inc. 69097-289-07 100 TABLET in 1 BOTTLE (69097-289-07)
Cipla Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Cipla USA Inc. 69097-289-70 50 TABLET in 1 BOTTLE (69097-289-70)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6351-61 100 BLISTER PACK in 1 CARTON (0904-6351-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6352-61 100 BLISTER PACK in 1 CARTON (0904-6352-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6353-61 100 BLISTER PACK in 1 CARTON (0904-6353-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA A-S Medication Solutions 50090-4928-0 5 TABLET, FILM COATED in 1 BOTTLE (50090-4928-0)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA A-S Medication Solutions 50090-4928-1 7 TABLET, FILM COATED in 1 BOTTLE (50090-4928-1)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA A-S Medication Solutions 50090-4928-2 10 TABLET, FILM COATED in 1 BOTTLE (50090-4928-2)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-279-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-279-01)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-279-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-279-05)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-279-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-279-30)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-279-50 50 TABLET, FILM COATED in 1 BOTTLE (55111-279-50)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-279-78 10 BLISTER PACK in 1 CARTON (55111-279-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-279-79)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-280-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-280-01)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-280-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-280-05)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-280-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-280-30)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-280-50 50 TABLET, FILM COATED in 1 BOTTLE (55111-280-50)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-280-78 10 BLISTER PACK in 1 CARTON (55111-280-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-280-79)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-281-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-281-01)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-281-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-281-05)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-281-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-281-30)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-281-50 50 TABLET, FILM COATED in 1 BOTTLE (55111-281-50)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Dr. Reddy's Laboratories Limited 55111-281-78 10 BLISTER PACK in 1 CARTON (55111-281-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-281-79)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Cardinal Health 55154-5897-0 10 BLISTER PACK in 1 BAG (55154-5897-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Cardinal Health 55154-5898-0 10 BLISTER PACK in 1 BAG (55154-5898-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA RedPharm Drug, Inc. 67296-0977-1 10 TABLET, FILM COATED in 1 BOTTLE (67296-0977-1)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA RedPharm Drug, Inc. 67296-0977-5 5 TABLET, FILM COATED in 1 BOTTLE (67296-0977-5)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA RedPharm Drug, Inc. 67296-0977-7 7 TABLET, FILM COATED in 1 BOTTLE (67296-0977-7)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA RedPharm Drug, Inc. 67296-1325-3 3 TABLET, FILM COATED in 1 BOTTLE (67296-1325-3)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA REMEDYREPACK INC. 70518-0453-0 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-0)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA REMEDYREPACK INC. 70518-0453-1 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-1)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA REMEDYREPACK INC. 70518-0453-2 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0453-2)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA REMEDYREPACK INC. 70518-0932-0 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0932-0)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA REMEDYREPACK INC. 70518-0932-2 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0932-2)
Dr Reddys Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA REMEDYREPACK INC. 70518-0932-3 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0932-3)
Hec Pharm LEVOFLOXACIN levofloxacin TABLET;ORAL 204968 ANDA Sunshine Lake Pharma CO., LTD. 48792-7814-1 50 TABLET, FILM COATED in 1 BOTTLE (48792-7814-1)
Hec Pharm LEVOFLOXACIN levofloxacin TABLET;ORAL 204968 ANDA Sunshine Lake Pharma CO., LTD. 48792-7815-1 50 TABLET, FILM COATED in 1 BOTTLE (48792-7815-1)
Hec Pharm LEVOFLOXACIN levofloxacin TABLET;ORAL 204968 ANDA Sunshine Lake Pharma CO., LTD. 48792-7816-1 20 TABLET, FILM COATED in 1 BOTTLE (48792-7816-1)
Hetero Labs Ltd V LEVOFLOXACIN levofloxacin TABLET;ORAL 202801 ANDA Camber Pharmaceuticals, Inc. 31722-721-31 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-721-31)
Hetero Labs Ltd V LEVOFLOXACIN levofloxacin TABLET;ORAL 202801 ANDA Camber Pharmaceuticals, Inc. 31722-721-32 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-721-32)
Hetero Labs Ltd V LEVOFLOXACIN levofloxacin TABLET;ORAL 202801 ANDA Camber Pharmaceuticals, Inc. 31722-721-50 50 TABLET, FILM COATED in 1 BOTTLE (31722-721-50)
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Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA Macleods Pharmaceuticals Limited 33342-021-08 50 TABLET, FILM COATED in 1 BOTTLE (33342-021-08)
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Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA REMEDYREPACK INC. 70518-2145-0 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2145-0)
Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA REMEDYREPACK INC. 70518-2145-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2145-1)
Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA REMEDYREPACK INC. 70518-2249-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2249-0)
Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA Denton Pharma, Inc. DBA Northwind Pharmaceuticals 70934-337-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-337-07)
Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA Denton Pharma, Inc. DBA Northwind Pharmaceuticals 70934-392-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-392-07)
Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839 ANDA Denton Pharma, Inc. DBA Northwind Pharmaceuticals 70934-392-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-392-10)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5790-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5790-01)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5790-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5790-10)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5790-50 50 TABLET, FILM COATED in 1 BOTTLE (0781-5790-50)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5791-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5791-01)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5791-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5791-10)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5791-50 50 TABLET, FILM COATED in 1 BOTTLE (0781-5791-50)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5792-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5792-01)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5792-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5792-10)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5792-20 20 TABLET, FILM COATED in 1 BOTTLE (0781-5792-20)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5792-50 50 TABLET, FILM COATED in 1 BOTTLE (0781-5792-50)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA A-S Medication Solutions 50090-1897-1 7 TABLET, FILM COATED in 1 BOTTLE (50090-1897-1)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-233-14 14 TABLET, FILM COATED in 1 BOTTLE (55700-233-14)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Proficient Rx 63187-003-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-003-10)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Proficient Rx 63187-004-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-004-10)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA RedPharm Drug, Inc. 67296-0744-1 5 TABLET, FILM COATED in 1 BOTTLE (67296-0744-1)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA RedPharm Drug, Inc. 67296-0744-2 7 TABLET, FILM COATED in 1 BOTTLE (67296-0744-2)
Sandoz LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Denton Pharma, Inc. dba Northwind Pharmaceuticals 70934-738-05 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-738-05)
Teva LEVOFLOXACIN levofloxacin TABLET;ORAL 076361 ANDA Medsource Pharmaceuticals 45865-758-07 7 TABLET, FILM COATED in 1 BOTTLE (45865-758-07)
Teva LEVOFLOXACIN levofloxacin TABLET;ORAL 076361 ANDA Medsource Pharmaceuticals 45865-758-14 14 TABLET, FILM COATED in 1 BOTTLE (45865-758-14)
Teva LEVOFLOXACIN levofloxacin TABLET;ORAL 076361 ANDA Medsource Pharmaceuticals 45865-758-30 30 TABLET, FILM COATED in 1 BOTTLE (45865-758-30)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-05 5 TABLET, FILM COATED in 1 BOTTLE (63187-514-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-07 7 TABLET, FILM COATED in 1 BOTTLE (63187-514-07)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-514-10)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-15 15 TABLET, FILM COATED in 1 BOTTLE (63187-514-15)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-514-30)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-514-60)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Proficient Rx LP 63187-514-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-514-90)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Bryant Ranch Prepack 63629-7050-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-7050-1)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Bryant Ranch Prepack 63629-7050-2 10 TABLET, FILM COATED in 1 BOTTLE (63629-7050-2)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Bryant Ranch Prepack 63629-7050-3 3 TABLET, FILM COATED in 1 BOTTLE (63629-7050-3)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Bryant Ranch Prepack 63629-7050-4 5 TABLET, FILM COATED in 1 BOTTLE (63629-7050-4)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-691-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-691-01)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-691-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-691-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-691-18 50 TABLET, FILM COATED in 1 BOTTLE (65841-691-18)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-692-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-692-01)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-692-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-692-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-692-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-692-10)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-692-18 50 TABLET, FILM COATED in 1 BOTTLE (65841-692-18)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-693-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-693-01)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-693-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-693-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Cadila Healthcare Limited 65841-693-18 50 TABLET, FILM COATED in 1 BOTTLE (65841-693-18)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA RedPharm Drug, Inc. 67296-1119-1 10 TABLET, FILM COATED in 1 BOTTLE (67296-1119-1)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA RedPharm Drug, Inc. 67296-1119-5 5 TABLET, FILM COATED in 1 BOTTLE (67296-1119-5)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA RedPharm Drug, Inc. 67296-1119-7 7 TABLET, FILM COATED in 1 BOTTLE (67296-1119-7)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA RedPharm Drug, Inc. 67296-1123-1 10 TABLET, FILM COATED in 1 BOTTLE (67296-1123-1)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA RedPharm Drug, Inc. 67296-1123-7 7 TABLET, FILM COATED in 1 BOTTLE (67296-1123-7)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-015-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-015-01)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-015-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-015-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-015-18 50 TABLET, FILM COATED in 1 BOTTLE (68382-015-18)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-016-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-016-01)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-016-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-016-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-016-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-016-10)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-016-18 50 TABLET, FILM COATED in 1 BOTTLE (68382-016-18)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-017-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-017-01)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-017-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-017-05)
Zydus Pharms Usa Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-017-18 50 TABLET, FILM COATED in 1 BOTTLE (68382-017-18)
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

API manufacturers for levofloxacin

Vendor Vendor Homepage Vendor Sku API Url
NIH Clinical Collection http://www.nihclinicalcollection.com/ SAM001246758
NovoSeek http://www.novoseek.com 149096 http://www.novoseek.com/AccessPoint.action?corpus=MEDLINE&externalDBId=cid%3d149096&DBName=pubchem&actionName=search&bioType=drug
Sigma-Aldrich http://www.sigmaaldrich.com 28266_SIGMA https://www.sigmaaldrich.com/catalog/product/sigma/28266?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
TCI (Tokyo Chemical Industry) http://www.tcichemicals.com/en/us/ L0193 http://www.tcichemicals.com/eshop/en/us/commodity/L0193/index.html
MolPort https://www.molport.com MolPort-002-885-835 https://www.molport.com/shop/molecule-link/MolPort-002-885-835
Hangzhou APIChem Technology http://www.apichemistry.com AC-7593
Alsachim http://www.alsachim.com 853 http://www.alsachim.com/product-C2615-glo.bal-view.html
ABI Chem http://www.abichem.com AC1L3YF8
ABBLIS Chemicals http://www.abblis.com AB1009501 http://www.abblis.com/100986-85-4.html
ChemMol http://chemmol.com/suppliers/ChemMol/301/1/ 30101095 http://www.chemmol.com/chemmol/30101095.html
ChemMol http://chemmol.com/suppliers/ChemMol/494/1/ 49401467 http://www.chemmol.com/chemmol/49401467.html
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS008901361 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS008901361
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS015895104 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS015895104
Chembase.cn http://www.chembase.cn 1008 http://www.chembase.cn/molecule-1008.html
AbaChemScene https://www.chemscene.com/ CS-2218 http://www.chemscene.com/100986-85-4.html
MedChemexpress MCE https://www.medchemexpress.com/ HY-B0330 https://www.medchemexpress.com/Levofloxacin.html
Wolves R&D chemical http://www.wolveschemical.com EBD8264 http://www.wolveschemical.com/product/100986-85-4.html
Assembly Blocks Pvt. Ltd. http://www.assemblyblocks.com AB0072147
A&J Pharmtech CO., LTD. http://www.ajpharmtech.com/ AJ-23383 http://www.ajpharmtech.com/
AN PharmaTech http://www.anpharma.net AN-8873
Syntree http://www.syntree.com/ ST24047487 http://www.syntree.com/100986-85-4
Founder Pharma http://www.pku-hc.com/en/ FD42099
Race Chemical http://www.racechemical.com RV022507209
Molepedia http://www.molepedia.com/ M90642452P http://www.molepedia.com/
Mcule https://mcule.com MCULE-2011834955 https://mcule.com/MCULE-2011834955/
Biosynth Carbosynth http://www.biosynth.com/ Q-201295 https://www.biosynth.com/en/products/life-science/culture-media-additives/products/Q-201295.html
ZINC http://zinc15.docking.org ZINC538273 http://zinc.docking.org/substances/ZINC538273/
AEchem Scientific Corp., USA http://www.aechemsc.com AE020182 http://www.aechemsc.com/info_products/AE020182.php
Aurora Fine Chemicals LLC http://www.aurorafinechemicals.com A17.890.330 http://online.aurorafinechemicals.com/info?ID=A17.890.330
TargetMol (Target Molecule Corp.) http://www.targetmol.com/ T1451 http://www.targetmol.com/compound/Levofloxacin-Hemihydrate
Clearsynth http://www.clearsynth.com/en/iis6954.asp CS-O-01741 http://www.clearsynth.com/en/CSO01741.html
Changzhou Highassay Chemical Co., Ltd http://www.highassay.com/profile/aboutus.html my_sub2352
Changzhou Highassay Chemical Co., Ltd http://www.highassay.com/profile/aboutus.html my_sub2353
TargetMol (Target Molecule Corp.) http://www.targetmol.com/ T6567 http://www.targetmol.com/compound/Levofloxacin
iChemical Technology USA Inc https://www.ichemical.com EBD8264 http://www.ichemical.com/products/100986-85-4.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
ApexBio Technology http://www.apexbt.com A5511 http://www.apexbt.com/ofloxacin.html
ApexBio Technology http://www.apexbt.com B1959 http://www.apexbt.com/levofloxacin.html
eNovation Chemicals D405132 https://www.enovationchem.com/ProductDetails.asp?ProductID=D405132
AbovChem LLC http://www.abovchem.com HY-B0330
Pi Chemicals http://www.pipharm.com PI-12401 http://www.pipharm.com/catalog/PI-12401.html
Pi Chemicals http://www.pipharm.com PI-15790 http://www.pipharm.com/catalog/PI-15790.html
ChemShuttle https://www.chemshuttle.com 151543 http://www.chemshuttle.com/catalogsearch/result/?q=100986-85-4&cat=
Sigma-Aldrich http://www.sigmaaldrich.com 40922_SIAL https://www.sigmaaldrich.com/catalog/product/sial/40922?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich http://www.sigmaaldrich.com L-038_CERILLIAN https://www.sigmaaldrich.com/catalog/product/cerillian/l038?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Acorn PharmaTech Product List http://www.acornpharmatech.com ACN-038325 http://www.acornpharmatech.com/
Enamine http://www.enamine.net Z1766089137 https://www.enaminestore.com/catalog/Z1766089137
LGC Standards https://www.lgcstandards.com LGCFOR0846.00 https://www.lgcstandards.com/US/en/p/LGCFOR0846.00
LGC Standards https://www.lgcstandards.com MM0846.00 https://www.lgcstandards.com/US/en/p/MM0846.00
OChem https://www.ocheminc.com 3793 http://www.ocheminc.com/index.php?act=psearch&pid=986L854
LabNetwork, a WuXi AppTec Company https://www.LabNetwork.com LN00235793 https://labnetwork.com/frontend-app/p/#!/moleculedetails/LN00235793
Selleck Chemicals http://www.selleckchem.com/ S1940 http://www.selleckchem.com/products/Levofloxacin(Levaquin).html
Chemieliva Pharmaceutical Co., Ltd http://www.chemieliva.com PBCM0016681
DC Chemicals https://www.dcchemicals.com DCAPI1002 http://www.dcchemicals.com/product_show-Levofloxacin (Levaquin).html
Chemenu Inc. http://www.chemenu.com/ CM110290 http://www.chemenu.com/products/CM110290
LGC Standards https://www.lgcstandards.com DRE-C14629730 https://www.lgcstandards.com/US/en/p/DRE-C14629730
MuseChem https://www.musechem.com I000113 https://www.musechem.com/product/I000113.html
Yuhao Chemical http://www.chemyuhao.com LT1250 http://www.chemyuhao.com/100986-85-4.html
Ambinter http://www.ambinter.com Amb2444040 http://www.ambinter.com/reference/2444040
Ambinter http://www.ambinter.com Amb20669810 http://www.ambinter.com/reference/20669810
AA BLOCKS http://www.aablocks.com AA0003AY http://www.aablocks.com/goods/Goods/detail?id=AA0003AY
Key Organics/BIONET https://www.keyorganics.net/bionet/ AS-31796 http://www.keyorganics.net/bionet/catalog/product/view/id/1016152
abcr GmbH http://www.abcr.de/en/homepage/ AB250203 http://www.abcr.de/shop/en/AB250203
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B2-6360 http://www.3bsc.com/index/pro_info.php?id=122847
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B1-01436 http://www.3bsc.com/index/pro_info.php?id=21648
BLD Pharm https://www.bldpharm.com/ BD0022 http://www.bldpharm.com/products/100986-85-4.html
Hairui Chemical http://www.hairuichem.com/en/ HR127302 http://www.hairuichem.com/en/product/100986-85-4.html
Ambeed https://www.ambeed.com/ A105051 https://www.ambeed.com/products/100986-85-4.html
VladaChem https://www.vladachem.com VL261985-25G https://www.vladachem.com/product.php?products=100986-85-4
Achemtek http://achemtek.com/ 0104-011027 http://www.achemtek.com/138199-71-0
Achemtek http://achemtek.com/ 0104-018860 http://www.achemtek.com/100986-85-4
Innovapharm http://www.innovapharm.com.ua BBS-00034040
Innovapharm http://www.innovapharm.com.ua STT-00466783
Activate Scientific https://activate-scientific.com AS112685 https://shop.activate-scientific.com/code/AS112685
CSNpharm http://www.csnpharm.com CSN10001 https://www.csnpharm.com/products/levofloxacin.html
Eximed Laboratory https://eximedlab.com EiM17-02662
eNovation Chemicals D674497 https://www.enovationchem.com/ProductDetails.asp?ProductID=D674497
Sinfoo Biotech http://sinfoobiotech.com/ S061060 http://www.sinfoobiotech.com/product/1064463
Aaron Chemicals LLC http://www.aaronchem.com/ AR00042Q http://www.aaronchem.com/100986-85-4
THE BioTek https://www.thebiotek.com/ bt-273347 https://www.thebiotek.com/product/inhibitors/bt-273347
Chem-Space.com Database https://chem-space.com CSSB00016993440 https://chem-space.com/CSSB00016993440
Smolecule https://www.smolecule.com/ S532946 http://www.smolecule.com/products/s532946
3WAY PHARM INC http://www.3wpharm.com/ SWE-02366 http://www.3wpharm.com/detail/SWE-02366.html
Vendor Vendor Homepage Vendor Sku API Url

Drug Master Files for levofloxacin

DMF No. Status Type Submission Date Holder Subject
10102 A II 2/26/1993 DAIICHI SANKYO CO LTD LEVOFLOXACIN DRUG SUBSTANCE
15672 A II 10/15/2001 QUIMICA SINTETICA SA LEVOFLOXACIN
15864 A II 2/15/2002 CIPLA LTD LEVOFLOXACIN HEMIHYDRATE USP
16521 A II 4/7/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD LEVOFLOXACIN
16616 I II 5/29/2003 YUHAN CHEMICAL INC LEVOFLOXACIN HEMIHYDRATE
16658 A II 6/24/2003 DR REDDYS LABORATORIES LTD LEVOFLOXACIN HEMIHYDRATE USP
16791 I II 8/26/2003 NEULAND LABORATORIES LTD LEVOFLOXACIN
16908 I II 10/14/2003 SUN PHARMACEUTICAL INDUSTRIES LTD LEVOFLOXACIN USP
16922 A II 10/21/2003 CIPLA LTD LEVOFLOXACIN HEMIHYDRATE USP
17532 A II 7/13/2004 MYLAN LABORATORIES LTD LEVOFLOXACIN USP (HEMIHYDRATE)
17580 A II 7/30/2004 ITF CHEMICAL LTDA LEVOFLOXACIN HEMIHYDRATE
18118 A II 2/23/2005 CADILA HEALTHCARE LTD LEVOFLOXACIN USP (HEMIHYDRATE)
18159 A II 3/8/2005 UQUIFA MEXICO SA DE CV LEVOFLOXACIN HEMIHYDRATE
18892 A II 10/21/2005 NEULAND LABORATORIES LTD LEVOFLOXACIN USP (HEMIHYDRATE)
19458 A II 5/19/2006 APOTEX PHARMACHEM INDIA PVT LTD LEVOFLOXACIN USP
19487 I II 5/30/2006 QUIMICA SINTETICA SA LEVOFLOXACIN
19511 A II 6/6/2006 ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD LEVOFLOXACIN HEMIHYDRATE, USP
20225 I II 1/29/2007 ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD LEVOFLOXACIN HEMIHYDRATE
22265 A II 12/6/2008 AUROBINDO PHARMA LTD LEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE)
22375 A II 12/31/2008 MACLEODS PHARMACEUTICALS LTD LEVOFLOXACIN HEMIHYDRATE
22990 A II 8/3/2009 LUPIN LTD LEVOFLOXACIN HEMIHYDRATE USP
23382 A II 12/17/2009 PAR A TECHNOLOGIES PRIVATE LTD LEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)
23639 A II 3/30/2010 ORCHID PHARMA LTD LEVOFLOXACIN (NON-STRILE BULK API)
23865 A II 6/7/2010 HETERO DRUGS LTD LEVOFLOXACIN HEMIHYDRATE, USP
24660 I II 2/21/2011 ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORY LEVOFLOXACIN DS
26295 A II 8/9/2012 HEC PHARM CO LTD LEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE
26712 A II 12/6/2012 ZHEJIANG LANGHUA PHARMACEUTICAL CO LTD LEVOFLOXACIN
28920 A II 12/15/2014 CHEMO IBERICA SA LEVOFLOXACIN
31998 A II 7/19/2017 ZHEJIANG MEDICINE CO LTD LEVOFLOXACIN
32663 A II 3/30/2018 MSN LIFE SCIENCES PRIVATE LTD LEVOFLOXACIN HEMIHYDRATE USP
33244 A II 10/16/2018 TURTLE PHARMA PRIVATE LTD LEVOFLOXACIN HEMIHYDRATE USP
DMF No. Status Type Submission Date Holder Subject

lopinavir; ritonavir

Finished product suppliers for lopinavir; ritonavir

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251 NDA AbbVie Inc. 0074-3956-46 1 BOTTLE in 1 CARTON (0074-3956-46) > 160 mL in 1 BOTTLE
Lannett Co Inc LOPINAVIR AND RITONAVIR lopinavir; ritonavir SOLUTION;ORAL 207407 ANDA Lannett Company, Inc. 0527-1947-48 1 BOTTLE, PLASTIC in 1 CARTON (0527-1947-48) > 160 mL in 1 BOTTLE, PLASTIC
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906 NDA AbbVie Inc. 0074-0522-60 60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60)
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906 NDA AbbVie Inc. 0074-1575-21 60 TABLET, FILM COATED in 1 BOTTLE (0074-1575-21)
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906 NDA AbbVie Inc. 0074-2605-21 120 TABLET, FILM COATED in 1 BOTTLE (0074-2605-21)
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906 NDA AbbVie Inc. 0074-6799-22 120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22)
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906 NDA PD-Rx Pharmaceuticals, Inc. 55289-947-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-947-12)
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906 NDA REMEDYREPACK INC. 70518-0091-2 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0091-2)
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

Drug Master Files for lopinavir; ritonavir

DMF No. Status Type Submission Date Holder Subject
14807 I II 3/29/2000 CATALENT PHARMA SOLUTIONS LLC LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES
19600 I II 7/17/2006 MYLAN LABORATORIES LTD LOPINAVIR (LVR)
19852 A II 10/10/2006 HETERO LABS LTD LOPINAVIR USP
19862 A II 10/9/2006 AUROBINDO PHARMA LTD LOPINAVIR (NON STERILE DRUG SUBSTANCE)
20363 A II 5/30/2007 MYLAN LABORATORIES LTD LOPINAVIR USP (LOP)
20756 I II 8/7/2007 MATRIX LABORATORIES LTD LOPINAVIR (LOR)
21101 I II 12/3/2007 RANBAXY LABORATORIES LTD Lopinavir Drug Substance
23256 I II 11/10/2009 DR REDDYS LABORATORIES LTD LOPINAVIR
26303 A II 8/13/2012 HETERO DRUGS LTD LOPINAVIR AMORPHOUS
27462 A II 9/27/2013 CIPLA LTD LOPINAVIR USP
28244 A II 4/28/2014 ACEBRIGHT INDIA PHARMA PRIVATE LTD LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)]
30154 A II 12/8/2015 SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD LOPINAVIR
30636 A II 7/30/2016 HETERO LABS LTD LOPINAVIR (PROCESS-II)
DMF No. Status Type Submission Date Holder Subject

niclosamide

API manufacturers for niclosamide

Vendor Vendor Homepage Vendor Sku API Url
Sigma-Aldrich http://www.sigmaaldrich.com N3510_SIGMA https://www.sigmaaldrich.com/catalog/product/sigma/n3510?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Hangzhou Trylead Chemical Technology http://www.trylead-chem.com/ TL8003360
NovoSeek http://www.novoseek.com 4477 http://www.novoseek.com/AccessPoint.action?corpus=MEDLINE&externalDBId=cid%3d4477&DBName=pubchem&actionName=search&bioType=drug
Vitas-M Laboratory http://www.vitasmlab.biz STK396676 http://www.request.vitasmlab.biz/index.php?option=com_search_stk&Itemid=22&stk=STK396676&?utm_source=pubchem&utm_medium=p_search_link&utm_campaign=pubchem_search&utm_content=pubchem_slink
MP Biomedicals http://www.mpbio.com 155827 http://www.mpbio.com/product_info.php?open=&cPath=&selecttab=&family_key=02155827
MolPort https://www.molport.com MolPort-000-181-408 https://www.molport.com/shop/molecule-link/MolPort-000-181-408
ABI Chem http://www.abichem.com AC1L1I97
AKos Consulting & Solutions http://www.akosgmbh.de/AKosSamples/index.html AKOS003589004 http://akoscompounds.de/catalogue/akossamplesretrieval.php?IDNUMBERS=AKOS003589004
ABI Chem http://www.abichem.com AC1Q786G
ABI Chem http://www.abichem.com AC1Q78UJ
Vitas-M Laboratory http://www.vitasmlab.biz BBL004110 http://www.request.vitasmlab.biz/index.php?option=com_search_stk&Itemid=22&stk=BBL004110&?utm_source=pubchem&utm_medium=p_search_link&utm_campaign=pubchem_search&utm_content=pubchem_slink
ChemMol http://chemmol.com/suppliers/ChemMol/494/1/ 49409397 http://www.chemmol.com/chemmol/49409397.html
EMD Biosciences http://www.emdbiosciences.com 481909 http://www.emdbiosciences.com/product/481909
Amadis Chemical http://amadischem.com/ A828227 http://www.amadischem.com/en-US/ProductDetail.aspx?catalog=A828227
Enamine http://www.enamine.net/ EN300-92958 https://www.enaminestore.com/catalog/EN300-92958
ABBLIS Chemicals http://www.abblis.com AB1011456 http://www.abblis.com/50-65-7.html
TimTec http://www.timtec.net ST50408862
BioChemPartner http://www.biochempartner.com BCP9000068
Chembase.cn http://www.chembase.cn 4480 http://www.chembase.cn/molecule-4480.html
AK Scientific, Inc. (AKSCI) http://www.aksci.com I012 http://www.aksci.com/item_detail.php?cat=I012
ChemTik http://www.chemtik.com/ CTK8G1852 http://www.chemtik.com/pro_result/861841/
EMD Millipore http://www.emdbiosciences.com 481909 http://www.emdbiosciences.com/product/481909
Finetech Industry Limited http://www.finetechnology-ind.com FT-0603220 http://www.finetechnology-ind.com/prod/detail/pub/50-65-7.html
Mcule https://mcule.com MCULE-9985514311 https://mcule.com/MCULE-9985514311/
Key Organics/BIONET https://www.keyorganics.net/bionet/ KS-5210 http://www.keyorganics.net/bionet/catalog/product/view/id/101626
Angene Chemical http://www.angenechemical.com AGN-PC-08WHBK http://www.angenechemical.com/productshow/AGN-PC-08WHBK.html
AbaChemScene https://www.chemscene.com/ CS-2618 http://www.chemscene.com/50-65-7.html
MedChemexpress MCE https://www.medchemexpress.com/ HY-B0497 https://www.medchemexpress.com/Niclosamide.html
Assembly Blocks Pvt. Ltd. http://www.assemblyblocks.com AB0013423
A&J Pharmtech CO., LTD. http://www.ajpharmtech.com/ AJ-46400 http://www.ajpharmtech.com/
AN PharmaTech http://www.anpharma.net AN-15637
Aurum Pharmatech LLC http://www.Aurumpharmatech.com T7903 http://www.Aurumpharmatech.com/Product/ProductDetails/T7903
ChemMol http://chemmol.com/ 99097726 http://www.chemmol.com/chemmol/99097726.html
labseeker https://www.labseeker.com SC-46581 http://www.labseeker.com/goods.php?id=20991
Tocris Bioscience https://www.tocris.com 4079 https://www.tocris.com/products/niclosamide_4079
Ark Pharm, Inc. http://www.arkpharminc.com/ AK173020 http://www.arkpharminc.com/products/50-65-7.html
AHH Chemical co.,ltd http://www.ahhchemical.com API-1745 http://www.ahhchemical.com/product/API-1745.html
BOC Sciences https://www.bocsci.com/ 50-65-7 https://www.bocsci.com/niclosamide-cas-50-65-7-item-84-344740.html
Biosynth Carbosynth http://www.biosynth.com/ Q-201469 https://www.biosynth.com/en/products/life-science/enzyme-substrates-reagents/products/Q-201469.html
Hello Bio https://www.hellobio.com HB1435 https://www.hellobio.com/niclosamide.html
ZINC http://zinc15.docking.org ZINC3874496 http://zinc.docking.org/substances/ZINC3874496/
Aurora Fine Chemicals LLC http://www.aurorafinechemicals.com K04.832.702 http://online.aurorafinechemicals.com/info?ID=K04.832.702
Glentham Life Sciences Ltd. http://www.glentham.com GA5338 http://www.glentham.com/products/product/GA5338/
Biocore http://www.biocore-tech.com BIE024128 http://www.biocore-tech.com/my/searchPro.htm?id=6670432fc5b4449aa61e1c62bc540349
TargetMol (Target Molecule Corp.) http://www.targetmol.com/ T0711 http://www.targetmol.com/compound/Niclosamide
abcr GmbH http://www.abcr.de/en/homepage/ AB372324 http://www.abcr.de/shop/en/AB372324
iChemical Technology USA Inc https://www.ichemical.com EBD38831 http://www.ichemical.com/chemicals/cas-50-65-7
ApexBio Technology http://www.apexbt.com B2283 http://www.apexbt.com/niclosamide.html
AbovChem LLC http://www.abovchem.com HY-B0497
Acadechem https://www.acadechemical.com ACDS-028814 http://www.acadechemical.com/product/103513
ChemShuttle https://www.chemshuttle.com 141644 http://www.chemshuttle.com/catalogsearch/result/?q=50-65-7&cat=
Pi Chemicals http://www.pipharm.com PI-11452 http://www.pipharm.com/catalog/PI-11452.html
Sigma-Aldrich http://www.sigmaaldrich.com N0560000_SIAL https://www.sigmaaldrich.com/catalog/product/sial/n0560000?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Enamine http://www.enamine.net Z57902203 https://www.enaminestore.com/catalog/Z57902203
LGC Standards https://www.lgcstandards.com DRE-C15510000 https://www.lgcstandards.com/US/en/p/DRE-C15510000
LGC Standards https://www.lgcstandards.com LGCFOR0361.00 https://www.lgcstandards.com/US/en/p/LGCFOR0361.00
LGC Standards https://www.lgcstandards.com MM0361.00 https://www.lgcstandards.com/US/en/p/MM0361.00
Wubei-Biochem http://www.wubei-biochem.com/ WB023113SU http://wubei-biochem.com/product/593701
King Scientific http://www.kingscientific.com KS-00000JFD http://www.kingscientific.com/goods/Goods/detail?id=KS-00000JFD
Selleck Chemicals http://www.selleckchem.com/ S3030 http://www.selleckchem.com/products/niclosamide-niclocide.html
AbMole Bioscience http://www.abmole.com/ M2055 http://www.abmole.com/products/niclosamide.html
Chemieliva Pharmaceutical Co., Ltd http://www.chemieliva.com PBCM0604138
Chemenu Inc. http://www.chemenu.com/ CM110596 http://www.chemenu.com/products/CM110596
MuseChem https://www.musechem.com A000928 https://www.musechem.com/product/A000928.html
Yuhao Chemical http://www.chemyuhao.com HL1041 http://www.chemyuhao.com/50-65-7.html
Combi-Blocks https://www.combi-blocks.com OR-0078 http://www.combi-blocks.com/cgi-bin/find.cgi?OR-0078
AA BLOCKS http://www.aablocks.com AA0035B8 http://www.aablocks.com/goods/Goods/detail?id=AA0035B8
3B Scientific (Wuhan) Corp http://www.3bsc.com 3B2-0772 http://www.3bsc.com/index/pro_info.php?id=20128
BioChemPartner http://www.biochempartner.com/ BCP22958 http://www.biochempartner.com/50-65-7-BCP22958
Acros Organics https://www.fishersci.com AC461840250 https://www.fishersci.com/shop/products/niclosamide-97-acros-organics-1/AC461840250
Acros Organics https://www.fishersci.com AC461841000 https://www.fishersci.com/shop/products/niclosamide-97-acros-organics/AC461841000
Synblock Inc http://www.synblock.com/ SB19414 http://www.synblock.com/product/50-65-7.html
VladaChem https://www.vladachem.com VL264556-100G https://www.vladachem.com/product.php?products=50-65-7
Achemtek http://achemtek.com/ 0104-015424 http://www.achemtek.com/50-65-7
Achemtek http://achemtek.com/ 1ST20493 http://achemtek.com/50-65-7-2
BioCrick https://www.biocrick.com/ BCC5081 http://www.biocrick.com/Niclosamide-BCC5081.html
Norris Pharm http://www.norris-pharm.com/ NSZB-A195336
eNovation Chemicals D630733 https://www.enovationchem.com/ProductDetails.asp?ProductID=D630733
Debye Scientific Co., Ltd DB-051812 http://www.debyesci.com/cas_50-65-7.html
eNovation Chemicals D672942 https://www.enovationchem.com/ProductDetails.asp?ProductID=D672942
Sinfoo Biotech http://sinfoobiotech.com/ S013157 http://www.sinfoobiotech.com/product/1016555
eNovation Chemicals D765674 https://www.enovationchem.com/ProductDetails.asp?ProductID=D765674
Matrix Scientific https://www.matrixscientific.com 203850 https://www.matrixscientific.com/203850.html
Aaron Chemicals LLC http://www.aaronchem.com/ AR003630 http://www.aaronchem.com/50-65-7
THE BioTek https://www.thebiotek.com/ bt-287919 https://www.thebiotek.com/product/inhibitors/bt-287919
Chem-Space.com Database https://chem-space.com CSSB00000764091 https://chem-space.com/CSSB00000764091
Alfa Chemistry https://alfa-chemistry.com AP50657 https://reagents.alfa-chemistry.com/product/niclosamide-cas-50-65-7-cas-50-65-7-12166.html
Smolecule https://www.smolecule.com/ S548510 http://www.smolecule.com/products/s548510
Speranza Chemical Co., Ltd. https://www.speranzachem.com C057 http://www.speranzachem.com/products-50-65-7.html
Vendor Vendor Homepage Vendor Sku API Url

Drug Master Files for niclosamide

DMF No. Status Type Submission Date Holder Subject
25273 A II 10/6/2011 BAYER AG NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE
25274 A II 10/6/2011 BAYER AG NICLOSAMIDE 500MG TABLET
4146 I II 1/31/1981 US COTTON LLC NICLOSAMIDE
DMF No. Status Type Submission Date Holder Subject

Nitric Oxide

Finished product suppliers for Nitric Oxide

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845 NDA INO Therapeutics 64693-002-01 1 CYLINDER in 1 CARTON (64693-002-01) > 353 L in 1 CYLINDER
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845 NDA INO Therapeutics 64693-002-02 1 CYLINDER in 1 CARTON (64693-002-02) > 1963 L in 1 CYLINDER
Praxair Distribution NOXIVENT nitric oxide GAS;INHALATION 207141 ANDA Praxair Distribution, Inc 59579-101-01 2082 L in 1 CYLINDER (59579-101-01)
Praxair Distribution NOXIVENT nitric oxide GAS;INHALATION 207141 ANDA Praxair Distribution, Inc 59579-101-02 323 L in 1 CYLINDER (59579-101-02)
Praxair Distribution NOXIVENT nitric oxide GAS;INHALATION 207141 ANDA Praxair Distribution, Inc 59579-102-01 2082 L in 1 CYLINDER (59579-102-01)
Praxair Distribution NOXIVENT nitric oxide GAS;INHALATION 207141 ANDA Praxair Distribution, Inc 59579-102-02 323 L in 1 CYLINDER (59579-102-02)
Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package

API manufacturers for Nitric Oxide

Drug Master Files for Nitric Oxide

DMF No. Status Type Submission Date Holder Subject
10510 I II 9/27/1993 LIQUID CARBONIC INDUSTRIES CORP BULK GASES NITRIC OXIDE IN NITROGEN GAS MIXTURE PRODUCED IN OAK BROOK, ILLINOIS
11399 I II 3/13/1995 PURITAN BENNETT CORP NITRIC OXIDE IN NITROGEN GAS MIXTURE
11610 I II 7/28/1995 AIR LIQUIDE AMERICA CORP 2200 PPM NITRIC OXIDE/BALANCE NITROGEN GAS MIXTURE
15551 I II 7/11/2001 CAREFUSION CORP VIANOX-H (NITRIC OXIDE)
17472 I II 6/16/2004 INO THERAPEUTICS INC NITRIC OXIDE FOR INHALATION, 800PPM
24763 A II 3/15/2011 AIR LIQUIDE ELECTRONICS US LP NITRIC OXIDE
DMF No. Status Type Submission Date Holder Subject

remdesivir

Finished product suppliers for remdesivir

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787 NDA Gilead Sciences, Inc. 61958-2901-2 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE