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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04401579
The ClinicalTrials.gov registry entry for NCT04401579 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,033 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.
NCT04401579 reports 0 study locations.
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.
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