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CLINICAL TRIALS PROFILE FOR REMDESIVIR
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All Clinical Trials for Remdesivir
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03719586 | Investigational Therapeutics for the Treatment of People With Ebola Virus Disease | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 2018-10-30 | Background: Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 3 drugs with people who have Ebola and are in treatment centers. Objective: To study the safety and effectiveness of 3 drugs for people with Ebola virus. Eligibility: People of any age with Ebola infection who are in treatment centers Design: Participants will be screened with questions, medical history, and blood tests. Participants will be randomly assigned to get 1 of 3 study drugs: - ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart. - Remdesivir by IV over about 1 hour. It will be given once a day for 10 days. - Mab114 by IV for 30-60 minutes. It will be given 1 time. For at least a week, participants will stay in isolation in a clinic. They will: - Get supportive care and be monitored - Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood. - Get their study drug. - Be monitored for disease signs and drug side effects. They may get medicines for side effects. - Have blood and urine tests. Participants will stay in the clinic until they finish the study drug and are well enough to leave. Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples. |
| NCT04252664 | Mild/Moderate 2019-nCoV Remdesivir RCT | Not yet recruiting | Chinese Academy of Medical Sciences | Phase 3 | 2020-02-05 | 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. Given no specific antiviral therapy for 2019-nCoV infection and the availability of remdesvir as a potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with mild or moderate 2019-nCoV respiratory disease. |
| NCT04252664 | Mild/Moderate 2019-nCoV Remdesivir RCT | Not yet recruiting | Capital Medical University | Phase 3 | 2020-02-05 | 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. Given no specific antiviral therapy for 2019-nCoV infection and the availability of remdesvir as a potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with mild or moderate 2019-nCoV respiratory disease. |
| NCT04257656 | Severe 2019-nCoV Remdesivir RCT | Not yet recruiting | Capital Medical University | Phase 3 | 2020-02-05 | 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. Given no specific antiviral therapy for 2019-nCoV infection and the ready availability of remdesvir as a potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with severe 2019-nCoV respiratory disease. |
| NCT04280705 | Adaptive COVID-19 Treatment Trial | Not yet recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 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. |
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