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NCT04401579 · ClinicalTrials.gov registry record · Phase 3
Adaptive COVID-19 Treatment Trial 2 (ACTT-2)
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,033
- Enrollment target
NCT04401579: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04401579 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,033 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401579, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,033 participants
- Enrollment target
Study Summary
ACTT-2 will evaluate the combination of baricitinib 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, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Interventions
- OTHER Placebo
- DRUG Baricitinib
- DRUG Remdesivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,033 participants |
| Start Date | 2020-05-08 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 3 |
What the finished NCT04401579 record still lists
NCT04401579 is an interventional study that assigns participants to a tested intervention. Its 1,033 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04401579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04401579 about?
NCT04401579 is a clinical study titled "Adaptive COVID-19 Treatment Trial 2 (ACTT-2)". ACTT-2 will evaluate the combination of baricitinib 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 th...
What is the current status of trial NCT04401579?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,033 participants. The study started on 2020-05-08. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT04401579?
The interventions under investigation include: Placebo (OTHER), Baricitinib (DRUG), Remdesivir (DRUG).
Who is sponsoring clinical trial NCT04401579?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04401579's enrollment target sits among peer trials
1,033 288th of 2000 higher than 1,713 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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