Status:
TERMINATED
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
Lead Sponsor:
Atea Pharmaceuticals, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 out...
Eligibility Criteria
Inclusion
- Key
- 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
- 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).
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04396106
Start Date
May 26 2020
End Date
February 28 2022
Last Update
March 9 2023
Active Locations (37)
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1
Atea Study Site
Scottsdale, Arizona, United States, 85258
2
Atea Study Site
Davis, California, United States, 95817
3
Atea Study Site
Los Angeles, California, United States, 90017
4
Atea Study Site
Washington D.C., District of Columbia, United States, 20037