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NCT04492475 · ClinicalTrials.gov registry record · Phase 3
Adaptive COVID-19 Treatment Trial 3 (ACTT-3)
A Phase 3 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 969
- Enrollment target
- 20
- Study locations
NCT04492475: Completed Phase 3 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04492475 is a Phase 3 study of COVID-19 that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 969 participants, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04492475, a Phase 3 study of COVID-19, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 969 participants
- Enrollment target
- 20
- Study locations
Study Summary
ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
Primary Outcome
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Remdesivir
- DRUG Interferon beta-1a
Study Locations (20)
California
- UCSF Fresno Center for Medical Education and Research - Clinical Research Center - Fresno
- University of California San Diego Health - Jacobs Medical Center - La Jolla
- University of California Los Angeles Medical Center - Westwood Clinic - Los Angeles
- University of California Irvine Medical Center - Infectious Disease - Orange
- VA Palo Alto Health Care System - Infectious Diseases - Palo Alto
- Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases - Palo Alto
- University of California Davis Medical Center - Internal Medicine - Infectious Disease - Sacramento
- Naval Medical Center San Diego - Infectious Disease Clinic - San Diego
- University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of HIV, ID, and Global Medicine - San Francisco
- Cedars Sinai Medical Center - West Hollywood
Florida
- University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine - Gainesville
- University of Florida Health - Jacksonville - Department of Emergency Medicine - Jacksonville
- University of Miami Miller School of Medicine - Infectious Diseases - Miami
Colorado
- Eastern Colorado Health Care System - Aurora
- Denver Health Division of Hospital Medicine - Main Campus - Denver
Georgia
- Emory Vaccine Center - The Hope Clinic - Decatur
- Atlanta VA Medical Center - Infectious Diseases Clinic - Decatur
Alabama
- University of Alabama at Birmingham School of Medicine - Infectious Disease - Birmingham
Hawaii
- Tripler Army Medical Center (TAMC) - Honolulu
Illinois
- Northwestern Hospital - Infectious Disease - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 969 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 3 |
What the finished NCT04492475 record still lists
NCT04492475 is an interventional study that assigns participants to a tested intervention. The registered 969 participants enrollment target is mid-sized for trials with a published cap, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
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.
NCT04492475 names 20 study sites across 7 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04492475 about?
NCT04492475 is a clinical study titled "Adaptive COVID-19 Treatment Trial 3 (ACTT-3)". ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred ...
What is the current status of trial NCT04492475?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 969 participants. The study started on 2020-08-05. Estimated completion is 2020-12-21.
What conditions does trial NCT04492475 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04492475?
The interventions under investigation include: Placebo (OTHER), Remdesivir (DRUG), Interferon beta-1a (DRUG).
Who is sponsoring clinical trial NCT04492475?
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 NCT04492475 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04492475's enrollment target sits among peer trials
969 80th of 298 higher than 219 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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