A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19
Overview
- Phase
- Phase 2
- Intervention
- AT-527
- Conditions
- COVID-19
- Sponsor
- Atea Pharmaceuticals, Inc.
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hospitalized or in a hospital-affiliated confinement facility
- •SARS-CoV-2 positive
- •Initial COVID-19 symptom onset within 5 days prior to Screening
- •SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
- •Must also have a history of at least one of the following known risk factors for poor outcomes: obesity (BMI\>30), hypertension, diabetes or asthma.
Exclusion Criteria
- •Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 \<93% on room air or requires \>2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood pressure \< 90 mm Hg, diastolic blood pressure \< 60 mm Hg or PaO2/FiO2 \<300
- •Requires mechanical ventilation
- •Lobar or segmental consolidation on chest imaging.
- •Treatment with other drugs thought to possibly have activity against SARS-CoV-2
- •ALT or AST \> 5 x upper limit of normal (ULN)
- •Female subject is pregnant or breastfeeding
- •Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 14 visit (Part B).
Arms & Interventions
AT-527 - 550 mg BID
Part A
Intervention: AT-527
Placebo for 550 mg BID
Part A
Intervention: Placebo
AT-527 - 1100 mg BID
Part B
Intervention: AT-527
Placebo for 1100 mg BID
Part B
Intervention: Placebo
Outcomes
Primary Outcomes
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
Time Frame: Day 14
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 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death
Secondary Outcomes
- Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab(Through Day 14)