Clinical trial NCT04396106: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
timeFrame: Day 14
Secondary outcomes:
measure: Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab
timeFrame: Through Day 14
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Atea Study Site
state: Arizona
city: Davis
country: United States
facility: Atea Study Site
state: California
city: Los Angeles
country: United States
facility: Atea Study Site
state: California
city: Washington
country: United States
facility: Atea Study Site
state: District of Columbia
city: Orlando
country: United States
facility: Atea Study Site
state: Florida
city: Atlanta
country: United States
facility: Atea Study Site
state: Georgia
city: Chicago
country: United States
facility: Atea Study Site
state: Illinois
city: Chicago
country: United States
facility: Atea Study Site
state: Illinois
city: Boston
country: United States
facility: Atea Study Site
state: Massachusetts
city: Butte
country: United States
facility: Atea Study Site
state: Montana
city: Charlotte
country: United States
facility: Atea Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Atea Study Site
state: Ohio
city: Columbus
country: United States
facility: Atea Study Site
state: Ohio
city: Charleston
country: United States
facility: Atea Study Site
state: South Carolina
city: Columbia
country: United States
facility: Atea Study Site
state: South Carolina
city: Rosario
country: Argentina
facility: Atea Study Site
city: Vicente Lopez
country: Argentina
facility: Atea Study Site
city: Brussels
country: Belgium
facility: Atea Study Site
city: Mechelen
country: Belgium
facility: Atea Study Site
city: Belo Horizonte
country: Brazil
facility: Atea Study Site
city: Brasília
country: Brazil
facility: Atea Study Site
city: Campo Largo
country: Brazil
facility: Atea Study Site
city: Porto Alegre
country: Brazil
facility: Atea Study Site
city: São Paulo
country: Brazil
facility: Atea Study Site
city: Cairo
country: Egypt
facility: Atea Study Site
city: Chisinau
country: Moldova, Republic of
facility: Atea Study Site
city: Bucharest
country: Romania
facility: Atea Study Site
city: Bloemfontein
country: South Africa
facility: Atea Study Site
city: Cape Town
country: South Africa
facility: Atea Study Site
city: Centurion
country: South Africa
facility: Atea Study Site
city: George
country: South Africa
facility: Atea Study Site
city: Worcester
country: South Africa
facility: Atea Study Site
city: Barcelona
country: Spain
facility: Atea Study Site
city: Madrid
country: Spain
facility: Atea Study Site
city: Pozuelo De Alarcón
country: Spain
facility: Atea Study Site
city: Brovary
country: Ukraine
facility: Atea Study Site
city: Kyiv
country: Ukraine
facility: Atea Study Site
Study officials:
References: