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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396106
Recruitment Status : Terminated (Study closed out early due to evolving COVID-19 standard of care)
First Posted : May 20, 2020
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 16, 2020
First Posted Date  ICMJE May 20, 2020
Last Update Posted Date May 23, 2022
Actual Study Start Date  ICMJE May 26, 2020
Actual Primary Completion Date January 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2021)
  • 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
  • Part B: Change from baseline in amount of SARS-CoV-2 virus RNA [ Time Frame: Through Day 14 ]
  • Parts A and B: Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • Proportions (active vs. placebo) of subjects who progress to respiratory failure [ Time Frame: Day 14 and Follow-up Day 14 ]
    Respiratory failure defined as requirement for intubated mechanical ventilation.
  • Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 14 and Follow-up Day 14 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2021)
Part A: Change from baseline in amount of SARS-CoV-2 virus RNA [ Time Frame: Through Day 14 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
Time to clinical recovery [ Time Frame: Day 14 ]
Clinical recovery defined as time from start of treatment until normal body temperature and respiratory rate (<20 breaths per minute), with sufficient alleviation of other signs and symptoms to support discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
Official Title  ICMJE A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Blinded
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: AT-527
    One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
  • Other: Placebo
    One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days
  • Drug: AT-527
    Dose B of AT-527 administered for a total of 5 days
  • Other: Placebo
    Dose B placebo tablets administered for a total of 5 days
Study Arms  ICMJE
  • Active Comparator: AT-527 - 550 mg BID
    Part A
    Intervention: Drug: AT-527
  • Placebo Comparator: Placebo for 550 mg BID
    Part A
    Intervention: Other: Placebo
  • Active Comparator: AT-527 - Dose B
    Part B
    Intervention: Drug: AT-527
  • Placebo Comparator: Placebo for Dose B
    Part B
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 17, 2022)
83
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2020)
180
Actual Study Completion Date  ICMJE February 28, 2022
Actual Primary Completion Date January 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Egypt,   Moldova, Republic of,   Romania,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04396106
Other Study ID Numbers  ICMJE AT-03A-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Atea Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Atea Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atea Pharmaceuticals, Inc.
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP