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NCT04280705 · ClinicalTrials.gov registry record · Phase 3
Adaptive COVID-19 Treatment Trial (ACTT)
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,062
- Enrollment target
NCT04280705 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,062 participants.
The verdict
NCT04280705, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,062 participants
- Enrollment target
Study Summary
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.
Interventions
- OTHER Placebo
- DRUG Remdesivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,062 participants |
| Start Date | 2020-02-21 |
| Est. Completion | 2020-05-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04280705
The ClinicalTrials.gov registry entry for NCT04280705 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,062 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 2 interventions - of which Placebo is the first listed.
NCT04280705 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04280705 about?
NCT04280705 is a clinical study titled "Adaptive COVID-19 Treatment Trial (ACTT)". This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study w...
What is the current status of trial NCT04280705?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,062 participants. The study started on 2020-02-21. Estimated completion is 2020-05-21.
What interventions are being tested in trial NCT04280705?
The interventions under investigation include: Placebo (OTHER), Remdesivir (DRUG).
Who is sponsoring clinical trial NCT04280705?
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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