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

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.
 
ClinicalTrials.gov Identifier: NCT04396106
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

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 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.

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 : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 - Dose B
Part B
Drug: AT-527
Dose B of AT-527 administered for a total of 5 days

Placebo Comparator: Placebo for Dose B
Part B
Other: Placebo
Dose B placebo tablets administered for a total of 5 days




Primary Outcome Measures :
  1. Part A: 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. Part B: Change from baseline in amount of SARS-CoV-2 virus RNA [ Time Frame: Through Day 14 ]
  3. Parts A and B: Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Part A: Change from baseline in amount of SARS-CoV-2 virus RNA [ Time Frame: Through Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 14 visit (Part B).

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 ClinicalTrials.gov identifier (NCT number): NCT04396106


Contacts
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Contact: Clinical Trials Administrator 888-481-1607 AteaClinicalTrials@ateapharma.com

Locations
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United States, Arizona
Atea Study Site Completed
Scottsdale, Arizona, United States, 85258
United States, California
Atea Study Site Recruiting
Davis, California, United States, 95817
Atea Study Site Recruiting
Los Angeles, California, United States, 90017
United States, District of Columbia
Atea Study Site Recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Atea Study Site Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Atea Study Site Recruiting
Atlanta, Georgia, United States, 30303
United States, Illinois
Atea Study Site Completed
Chicago, Illinois, United States, 60611
Atea Study Site Completed
Chicago, Illinois, United States, 60612
United States, Massachusetts
Atea Study Site Completed
Boston, Massachusetts, United States, 02115
United States, Montana
Atea Study Site Recruiting
Butte, Montana, United States, 59701
United States, North Carolina
Atea Study Site Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Atea Study Site Recruiting
Cincinnati, Ohio, United States, 45219
Atea Study Site Recruiting
Columbus, Ohio, United States, 43203
United States, South Carolina
Atea Study Site Recruiting
Charleston, South Carolina, United States, 29425
Atea Study Site Recruiting
Columbia, South Carolina, United States, 29203
Argentina
Atea Study Site Recruiting
Rosario, Argentina
Atea Study Site Recruiting
Vicente Lopez, Argentina
Belgium
Atea Study Site Recruiting
Brussels, Belgium
Atea Study Site Recruiting
Mechelen, Belgium
Brazil
Atea Study Site Recruiting
Belo Horizonte, Brazil
Atea Study Site Recruiting
Brasília, Brazil
Atea Study Site Recruiting
Campo Largo, Brazil
Atea Study Site Recruiting
Porto Alegre, Brazil
Atea Study Site Recruiting
São Paulo, Brazil
Egypt
Atea Study Site Recruiting
Cairo, Egypt
Moldova, Republic of
Atea Study Site Recruiting
Chisinau, Moldova, Republic of
Romania
Atea Study Site Recruiting
Bucharest, Romania
South Africa
Atea Study Site Recruiting
Bloemfontein, South Africa
Atea Study Site Recruiting
Cape Town, South Africa
Atea Study Site Recruiting
Centurion, South Africa
Atea Study Site Recruiting
George, South Africa
Atea Study Site Recruiting
Worcester, South Africa
Spain
Atea Study Site Recruiting
Barcelona, Spain
Atea Study Site Recruiting
Madrid, Spain
Atea Study Site Recruiting
Pozuelo De Alarcón, Spain
Ukraine
Atea Study Site Recruiting
Brovary, Ukraine
Atea Study Site Recruiting
Kyiv, Ukraine
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
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Responsible Party: Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04396106    
Other Study ID Numbers: AT-03A-001
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases