search
Back to results

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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AT-527
Placebo
AT-527
Placebo
Sponsored by
Atea Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site
  • Atea Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

AT-527 - 550 mg BID

Placebo for 550 mg BID

AT-527 - 1100 mg BID

Placebo for 1100 mg BID

Arm Description

Part A

Part A

Part B

Part B

Outcomes

Primary Outcome Measures

Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before 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, within the 14-day study period. Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 <93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death

Secondary Outcome Measures

Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab
Change in the viral load as measured by swab of the upper part of the pharynx.

Full Information

First Posted
May 16, 2020
Last Updated
February 8, 2023
Sponsor
Atea Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04396106
Brief Title
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Study closed out early due to evolving COVID-19 standard of care
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atea Pharmaceuticals, Inc.

4. Oversight

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

5. Study Description

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 (1100 mg BID). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Blinded
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AT-527 - 550 mg BID
Arm Type
Active Comparator
Arm Description
Part A
Arm Title
Placebo for 550 mg BID
Arm Type
Placebo Comparator
Arm Description
Part A
Arm Title
AT-527 - 1100 mg BID
Arm Type
Active Comparator
Arm Description
Part B
Arm Title
Placebo for 1100 mg BID
Arm Type
Placebo Comparator
Arm Description
Part B
Intervention Type
Drug
Intervention Name(s)
AT-527
Intervention Description
One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days
Intervention Type
Drug
Intervention Name(s)
AT-527
Intervention Description
Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days
Primary Outcome Measure Information:
Title
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
Description
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, within the 14-day study period. Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 <93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab
Description
Change in the viral load as measured by swab of the upper part of the pharynx.
Time Frame
Through Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Atea Study Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Atea Study Site
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Atea Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Atea Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Atea Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Atea Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Atea Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Atea Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Atea Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Atea Study Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Atea Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Atea Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Atea Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Atea Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Atea Study Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Atea Study Site
City
Rosario
Country
Argentina
Facility Name
Atea Study Site
City
Vicente Lopez
Country
Argentina
Facility Name
Atea Study Site
City
Brussels
Country
Belgium
Facility Name
Atea Study Site
City
Mechelen
Country
Belgium
Facility Name
Atea Study Site
City
Belo Horizonte
Country
Brazil
Facility Name
Atea Study Site
City
Brasília
Country
Brazil
Facility Name
Atea Study Site
City
Campo Largo
Country
Brazil
Facility Name
Atea Study Site
City
Porto Alegre
Country
Brazil
Facility Name
Atea Study Site
City
São Paulo
Country
Brazil
Facility Name
Atea Study Site
City
Cairo
Country
Egypt
Facility Name
Atea Study Site
City
Chisinau
Country
Moldova, Republic of
Facility Name
Atea Study Site
City
Bucharest
Country
Romania
Facility Name
Atea Study Site
City
Bloemfontein
Country
South Africa
Facility Name
Atea Study Site
City
Cape Town
Country
South Africa
Facility Name
Atea Study Site
City
Centurion
Country
South Africa
Facility Name
Atea Study Site
City
George
Country
South Africa
Facility Name
Atea Study Site
City
Worcester
Country
South Africa
Facility Name
Atea Study Site
City
Barcelona
Country
Spain
Facility Name
Atea Study Site
City
Madrid
Country
Spain
Facility Name
Atea Study Site
City
Pozuelo De Alarcón
Country
Spain
Facility Name
Atea Study Site
City
Brovary
Country
Ukraine
Facility Name
Atea Study Site
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs