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

Phase 2TerminatedNCT04396106

Atea Pharmaceuticals, Inc.83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COVID-19

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (37)

Atea Study Site

Scottsdale, Arizona, United States

Atea Study Site

Davis, California, United States

Atea Study Site

Los Angeles, California, United States

Atea Study Site

Washington D.C., District of Columbia, United States

Atea Study Site

Orlando, Florida, United States

Atea Study Site

Outcomes

Primary Outcomes

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

Time frame: Day 14

Secondary Outcomes

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.

Time frame: Through Day 14