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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04396106
• Other study ID #: AT-03A-001
• Status: Terminated
• Phase: Phase 2
• Start date: May 26, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2023
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: February 28, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

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
Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days

Other:
• Placebo
Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days

Locations

Country	Name	City	State
Argentina	Atea Study Site	Rosario
Argentina	Atea Study Site	Vicente Lopez
Belgium	Atea Study Site	Brussels
Belgium	Atea Study Site	Mechelen
Brazil	Atea Study Site	Belo Horizonte
Brazil	Atea Study Site	Brasília
Brazil	Atea Study Site	Campo Largo
Brazil	Atea Study Site	Porto Alegre
Brazil	Atea Study Site	São Paulo
Egypt	Atea Study Site	Cairo
Moldova, Republic of	Atea Study Site	Chisinau
Romania	Atea Study Site	Bucharest
South Africa	Atea Study Site	Bloemfontein
South Africa	Atea Study Site	Cape Town
South Africa	Atea Study Site	Centurion
South Africa	Atea Study Site	George
South Africa	Atea Study Site	Worcester
Spain	Atea Study Site	Barcelona
Spain	Atea Study Site	Madrid
Spain	Atea Study Site	Pozuelo De Alarcón
Ukraine	Atea Study Site	Brovary
Ukraine	Atea Study Site	Kyiv
United States	Atea Study Site	Atlanta	Georgia
United States	Atea Study Site	Boston	Massachusetts
United States	Atea Study Site	Butte	Montana
United States	Atea Study Site	Charleston	South Carolina
United States	Atea Study Site	Charlotte	North Carolina
United States	Atea Study Site	Chicago	Illinois
United States	Atea Study Site	Chicago	Illinois
United States	Atea Study Site	Cincinnati	Ohio
United States	Atea Study Site	Columbia	South Carolina
United States	Atea Study Site	Columbus	Ohio
United States	Atea Study Site	Davis	California
United States	Atea Study Site	Los Angeles	California
United States	Atea Study Site	Orlando	Florida
United States	Atea Study Site	Scottsdale	Arizona
United States	Atea Study Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Egypt,  Moldova, Republic of,  Romania,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 14
Secondary	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.	Through Day 14