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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: Clinical Trial Phase 2 study, sponsored by Atea Pharmaceuticals.
NCT04396106 is a Phase 2 study that was terminated before completion, run by Atea Pharmaceuticals. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progressive respiratory insufficiency defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using the 6-tier hierarchical scale of respiratory support methods, within the 14-day study period. Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 \<93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Le
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 |
Why NCT04396106 stopped before completion
NCT04396106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04396106 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04396106's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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