| 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.
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