Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Blinded

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
AT-527 - 550 mg BID 		Part A
  • Drug: AT-527
    One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
Placebo Comparator
Placebo for 550 mg BID 		Part A
  • Other: Placebo
    One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days
Active Comparator
AT-527 - 1100 mg BID 		Part B
  • Drug: AT-527
    Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
Placebo Comparator
Placebo for 1100 mg BID 		Part B
  • Other: Placebo
    Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days

Recruiting Locations

More Details

NCT ID
NCT04396106
Status
Terminated
Sponsor
Atea Pharmaceuticals, Inc.