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

NCT04396106 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-03-09

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Atea Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2022-01-10
Completion
2022-02-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Egypt
  • Moldova
  • Romania
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396106 on ClinicalTrials.gov