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

  • STATUS
    Recruiting
  • participants needed
    190
  • sponsor
    Atea Pharmaceuticals, Inc.
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Updated on 16 February 2024
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asthma
hypertension
covid-19
SARS
coronavirus infection
acute respiratory syndrome (sars)

Summary

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.

Details
Condition Covid 19
Age 45years - 80years
Treatment Placebo, AT-527
Clinical Study IdentifierNCT04396106
SponsorAtea Pharmaceuticals, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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