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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.