Overview
The objectives of this study are to evaluate the safety, tolerability and efficacy of AT-527 in older subjects (ages 45-80 years) 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. Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy and safety observations will be compared for treatment with active AT-527 tablets + SOC vs. placebo tablets + SOC.
Eligibility
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