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SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

NCT05629962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2285

Last updated 2025-06-13

Study results available
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Summary

The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.

Conditions

  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection)
  • COVID-19

Interventions

DRUG

Bemnifosbuvir (BEM)

BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days

DRUG

Placebo

Placebo tablets administered orally 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
2022-11-25
Primary Completion
2024-04-25
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Germany
  • India
  • Japan
  • Latvia
  • Mexico
  • Netherlands
  • Pakistan
  • Philippines
  • Romania
  • South Africa
  • Spain
  • Sweden
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT05629962 on ClinicalTrials.gov