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NCT04988035 · ClinicalTrials.gov registry record · Phase 2
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19
A Phase 2 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 201
- Enrollment target
- 20
- Study locations
NCT04988035 is a Phase 2 study of COVID-19 that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 201 participants, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT04988035, a Phase 2 study of COVID-19, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 201 participants
- Enrollment target
- 20
- Study locations
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 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 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-C stage will evaluate the combination of remdesivir with danicopan vs remdesivir with a placebo. Subjects will be assessed daily while hospitalized. Once subject
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Remdesivir
- DRUG Danicopan
Study Locations (20)
California
- Kern Medical Center - Bakersfield
- UCSF Fresno Center for Medical Education and Research - Clinical Research Center - Fresno
- University of California Los Angeles Medical Center - Westwood Clinic - Los Angeles
- Hoag Hospital Newport Beach - Newport Beach
Colorado
- Penrose Hospital - Emergency Medicine - Colorado Springs
- St. Francis Medical Center - Colorado Springs
- St. Anthony Hospital - Lakewood
- St. Anthony Hospital North Health Campus - Westminster
Connecticut
- Nuvance Health Danbury Hospital - Infectious Disease - Danbury
- Yale School of Medicine - The Anlyan Center for Medical Research & Education - Immunobiology - New Haven
- Nuvance Health - Norwalk Hospital - Asthma Pulmonary and Critical Care Medicine - Norwalk
Illinois
- Great Lakes Clinical Trials - Chicago
- Carle Foundation Hospital - Urbana
- Northwestern Medicine - Central DuPage Hospital - Infectious Disease - Winfield
Florida
- University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine - Gainesville
- Mayo Clinic Florida - Jacksonville
Kentucky
- Norton Healthcare - Louisville
- University of Louisville - Division of Infectious Diseases - Louisville
Alabama
- University of Alabama at Birmingham School of Medicine - Infectious Disease - Birmingham
Massachusetts
- Brigham and Women's Hospital - Infectious Diseases - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2021-08-03 |
| Est. Completion | 2022-04-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04988035
The ClinicalTrials.gov registry entry for NCT04988035 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). 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 1 condition, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04988035 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04988035 about?
NCT04988035 is a clinical study titled "ACTIV-5 / Big Effect Trial (BET-C) 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 COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive st...
What is the current status of trial NCT04988035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2021-08-03. Estimated completion is 2022-04-23.
What conditions does trial NCT04988035 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04988035?
The interventions under investigation include: Placebo (OTHER), Remdesivir (DRUG), Danicopan (DRUG).
Who is sponsoring clinical trial NCT04988035?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04988035 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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