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NCT04583969 · ClinicalTrials.gov registry record · Phase 2
ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 527
- Enrollment target
NCT04583969 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 527 participants.
The verdict
NCT04583969, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 527 participants
- Enrollment target
Study Summary
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 Coronavirus Disease 2019 (COVID-19). Big Effect Trial (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 70 domestic sites and 5 international sites. 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 200 (100 treatment and 100 shared placebo) 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 pr
Interventions
- OTHER Placebo
- DRUG Remdesivir
- BIOLOGICAL Lenzilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2022-04-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04583969
The ClinicalTrials.gov registry entry for NCT04583969 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 527 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04583969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04583969 about?
NCT04583969 is a clinical study titled "ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19". 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 Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying prom...
What is the current status of trial NCT04583969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 527 participants. The study started on 2020-10-23. Estimated completion is 2022-04-22.
What interventions are being tested in trial NCT04583969?
The interventions under investigation include: Placebo (OTHER), Remdesivir (DRUG), Lenzilumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04583969?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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