The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,000
Secutrelvir will be administered orally as a tablet.
Placebo will be administered orally as a tablet.
Proportion of Participants Experiencing Any Component of the Following Composite Endpoint: Targeted Medically Attended Visits (tMAVs) Due to Worsening COVID-19, All-cause Hospitalizations, or All-cause Deaths
Time frame: Baseline through Day 28
Time to Sustained Resolution of 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Proportion of Participants with tMAVs Due to Worsening COVID-19
Time frame: Baseline through Day 28
Proportion of Participants with All-cause Hospitalization or All-cause Death
Time frame: Baseline through Day 28
Proportion of Participants with Hospitalization Due to Worsening COVID-19
Time frame: Baseline through Day 28
Time to First Resolution of 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Time to Sustained Alleviation of 14 COVID 19 Symptoms
Time frame: Baseline through Day 28
Time to Sustained Resolution of Each of the 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Time to First Alleviation of 14 COVID-19 Symptoms
Time frame: Baseline through Day 28
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Ribonucleic Acid (RNA) Level
Time frame: Baseline through Day 28
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Hope Clinical Trials - 3970 W Flagler St.
Coral Gables, Florida, United States
NOT_YET_RECRUITINGContinental Clinical Research, LLC
Miami, Florida, United States
NOT_YET_RECRUITINGReed Medical Research
Miami, Florida, United States
NOT_YET_RECRUITINGKendall South Medical Center Inc.
Miami, Florida, United States
NOT_YET_RECRUITINGGlobal Clinical Professionals
St. Petersburg, Florida, United States
NOT_YET_RECRUITINGNew Tampa Health
Tampa, Florida, United States
NOT_YET_RECRUITINGResearch Bay, Inc.
Tampa, Florida, United States
NOT_YET_RECRUITINGHometown Urgent Care and Research
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGMedical Center Unimed EOOD
Sevlievo, Gabrovo, Bulgaria
NOT_YET_RECRUITINGMedichi Sofia - Medical Center OOD
Sofia, Sofia, Bulgaria
NOT_YET_RECRUITING...and 27 more locations
Number of Participants Returning to Usual Health
Time frame: Baseline through Day 28
Number of Participants Returning to Usual Activity
Time frame: Baseline through Day 28
Number of Participants Reporting No Symptoms
Time frame: Baseline through Day 28
Change from Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Score
Time frame: Baseline through Day 28
Plasma Concentration of Secutrelvir and Secutrelvir Metabolites
Time frame: Day 4, Day 8
Number of Participants with Treatment-emergent Adverse Events
Time frame: Baseline through Week 24