CLINICAL TRIALS PROFILE FOR REMDESIVIR
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505(b)(2) Clinical Trials for REMDESIVIR
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Dosage | NCT05187793 ↗ | Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab | Recruiting | Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor | Phase 3 | 2021-07-08 | The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial. |
| New Dosage | NCT05187793 ↗ | Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab | Recruiting | Group of companies Medsi, JSС | Phase 3 | 2021-07-08 | The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial. |
| New Dosage | NCT05187793 ↗ | Randomized Study of Efficacy of Different Treatment Regimens of Olokizumab | Recruiting | R-Pharm | Phase 3 | 2021-07-08 | The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2/Phase 3 | 2018-11-21 | 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 4 drugs with people who have Ebola and are in treatment centers. Objective: To study the safety and effectiveness of 4 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. - REGN-EB3 by IV for about 2 hours. 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 ↗ | A Trial of Remdesivir in Adults With Mild and Moderate COVID-19 | Suspended | Chinese Academy of Medical Sciences | Phase 3 | 2020-02-12 | 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 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 COVID-19. |
| NCT04252664 ↗ | A Trial of Remdesivir in Adults With Mild and Moderate COVID-19 | Suspended | Capital Medical University | Phase 3 | 2020-02-12 | 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 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 COVID-19. |
| NCT04257656 ↗ | A Trial of Remdesivir in Adults With Severe COVID-19 | Terminated | Capital Medical University | Phase 3 | 2020-02-06 | 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 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 COVID-19. |
| NCT04280705 ↗ | Adaptive COVID-19 Treatment Trial (ACTT) | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 2020-02-21 | This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. 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, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because 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 subjects. 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. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm. |
| NCT04282902 ↗ | A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection | Recruiting | Huilan Zhang | Phase 3 | 2020-02-04 | The acute lung injury caused by SARS and 2003 were both related to the inflammatory cytokine storm in patients. The biochemical test showed abnormal increase in related indicators such as interleukin-8, and CT images showed a medical "white" lung". According to the experience of SARS treatment in 2003, the use of hormones will indeed help the patients to alleviate their illness, but patients who survived SARS either had too much hormone at that time and took too long. Although the lungs could recover, but the femoral head was necrotic Either the amount of hormones was very conservative at the time, which kept the lungs in the storm of inflammatory factors, leading to the emergence of irreversible pulmonary fibrosis. So is there a medicine that can anti-inflammatory, reduce the load of hormone use, and have the effect of treating and preventing pulmonary fibrosis complicated by severe viral lung? At present, pirfenidone has achieved encouraging results in the treatment of idiopathic Pulmonary Fibrosis (CTD-ILD) diseases. It is particularly encouraging that the values announced at the 2019 ATS Annual Conference suggest that pirfenidone has more anti-inflammatory and anti-oxidant effects than its own outstanding anti-fibrotic ability. The data shows early use, Its strong anti-SOD activity can effectively inhibit IL-1beta and IL-4, and can open the prevention mode of pulmonary interstitial fibrosis. Based on the above, this project intends to make the following scientific assumptions: based on the homology of the pathogens of the new coronavirus-infected pneumonia and the coronavirus infection of pneumonia in 2003, the similarities in the occurrence and development of the disease, that is, the pulmonary inflammatory storm occurs first, and thereafter The progress of fibrosis and the progressive decline of lung function and mortality are higher than those of ordinary pneumonia. We hope that by adding pirfenidone as a treatment program in addition to standard treatment, it will be a new and severe type of coronavirus infection. Patient clinical treatment provides an effective and practical method. |
| NCT04292730 ↗ | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment | Completed | Gilead Sciences | Phase 3 | 2020-03-15 | The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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