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NCT04640168 · ClinicalTrials.gov registry record · Phase 3
Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
A Phase 3 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,010
- Enrollment target
- 20
- Study locations
NCT04640168: Completed Phase 3 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04640168 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 1,010 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 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640168, 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
- 1,010 participants
- Enrollment target
- 20
- Study locations
Study Summary
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. 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, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, 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 objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.
Primary Outcome
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Dexamethasone
- DRUG Baricitinib
- DRUG Remdesivir
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
- University of California Davis Medical Center - Internal Medicine - Infectious Disease - Sacramento
- Kaiser Permanente San Diego Medical Center - San Diego
- Naval Medical Center San Diego - Infectious Disease Clinic - San Diego
- University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine - San Francisco
- Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases - Stanford
- 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
- VA 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
District of Columbia
- Georgetown University Medical Center - Division of Infectious Diseases - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,010 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2021-06-18 |
| Phase | Phase 3 |
What the finished NCT04640168 record still lists
NCT04640168 is an interventional study that assigns participants to a tested intervention. Its 1,010 participants enrollment target places it among the larger protocols in the corpus, 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 4 interventions - of which Placebo is the first listed.
NCT04640168 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04640168 about?
NCT04640168 is a clinical study titled "Adaptive COVID-19 Treatment Trial 4 (ACTT-4)". ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. 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 prefe...
What is the current status of trial NCT04640168?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,010 participants. The study started on 2020-12-02. Estimated completion is 2021-06-18.
What conditions does trial NCT04640168 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04640168?
The interventions under investigation include: Placebo (OTHER), Dexamethasone (DRUG), Baricitinib (DRUG), Remdesivir (DRUG).
Who is sponsoring clinical trial NCT04640168?
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 NCT04640168 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04640168's enrollment target sits among peer trials
1,010 70th of 298 higher than 229 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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