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NCT04396106 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
A Phase 2 study, sponsored by Atea Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT04396106 is a Phase 2 study that was terminated before completion, run by Atea Pharmaceuticals. The registered enrollment target is 83 participants.
The verdict
NCT04396106, a Phase 2 study, was terminated before completion, sponsored by Atea Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI\>30), hypertension, diabetes or asthma). Eligible subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
Interventions
- OTHER Placebo
- DRUG AT-527
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04396106
The ClinicalTrials.gov registry entry for NCT04396106 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atea Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04396106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04396106 about?
NCT04396106 is a clinical study titled "Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting". The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI\>30), hypertension, diabetes or asthma). Eligible subjects will be rando...
What is the current status of trial NCT04396106?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2020-05-26. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT04396106?
The interventions under investigation include: Placebo (OTHER), AT-527 (DRUG).
Who is sponsoring clinical trial NCT04396106?
This trial is sponsored by Atea Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
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