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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04396106
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : July 31, 2020
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: AT-527 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Blinded
Primary Purpose: Treatment
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
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Active Comparator: AT-527 + SOC Drug: AT-527
One or two 550 mg tablet(s) of AT-527 administered on Day 1 followed by 1 tablet every ~12 hours (twice a day) + SOC for a total of 5 days

Placebo Comparator: Placebo + SOC Other: Placebo
One or two placebo tablet(s) administered on Day 1 followed by 1 tablet every ~12 hours (twice a day) + SOC for a total of 5 days

Primary Outcome Measures :
  1. Proportions (active vs. placebo) of subjects with progressive respiratory insufficiency. [ Time Frame: Day 14 ]
    Progressive respiratory insufficiency defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using the 6-tier hierarchical scale of respiratory support methods

  2. Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Time to clinical recovery [ Time Frame: Day 14 ]
    Clinical recovery defined as time from randomization to disease resolution status on an 8 point Clinical Status scale

  2. Proportions (active vs. placebo) of subjects with respiratory failure or death [ Time Frame: Day 28 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key 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.

Key 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04396106

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Contact: Clinical Trials Administrator 888-481-1607

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United States, California
Atea Study Site Recruiting
Sacramento, California, United States, 95817
United States, Georgia
Atea Study Site Recruiting
Atlanta, Georgia, United States, 30303
United States, Illinois
Atea Study Site Recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
Atea Study Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Montana
Atea Study Site Recruiting
Butte, Montana, United States, 59701
United States, Ohio
Atea Study Site Recruiting
Cincinnati, Ohio, United States, 45219
Atea Study Site Not yet recruiting
Columbus, Ohio, United States, 43203
United States, South Carolina
Atea Study Site Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Atea Study Site Recruiting
Houston, Texas, United States, 77030
United States, Washington
Atea Study Site Recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
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Responsible Party: Atea Pharmaceuticals, Inc. Identifier: NCT04396106    
Other Study ID Numbers: AT-03A-001
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No