A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19

AT-03A-001

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.

2020-05-26

2022-01-10

2022-02-28

Terminated

Early phase I

83

Key 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. Key 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).

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2023-03-09