Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Davis, California and other locations
Dates
study started
completion

Description

Summary

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 (Dose B). 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.

Official Title

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

Keywords

COVID-19 AT-527 - 550 mg BID

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Locations

  • Atea Study Site
    Davis California 95817 United States
  • Atea Study Site
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Atea Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT04396106
Phase
Phase 2 COVID-19 Research Study
Study Type
Interventional
Participants
At least 83 people participating
Last Updated