A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19

Conditions

COVID-19

Brief summary

The primary efficacy endpoint is the proportion of subjects in the supportive-care-only population who are hospitalized for any cause or died due to any cause through Day 29

Detailed description

Proportion of subjects with COVID-19-related hospitalization or who died due to any cause through Day 29, Proportion of subjects who died due to any cause through Day 29 and Day 60, Proportion of subjects with COVID-19-related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure) through Day 29, Proportion of subjects with COVID-19-related medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit) or who died due to any cause through Day 29 and Day 60, Proportion of subjects with COVID-19 symptom relapse through Day 29, Proportion of subjects with viral load rebound through Day 29, The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Related papers

No related papers found yet.

Interventions

DRUGPaxlovid 150 mg + 100 mg film-coated tablets

DRUGPlacebo to match Bemnifosbuvir Hemisulfate

DRUGBemnifosbuvir Hemisulfate

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the proportion of subjects in the supportive-care-only population who are hospitalized for any cause or died due to any cause through Day 29	—

Secondary

Measure	Time frame
Proportion of subjects with COVID-19-related hospitalization or who died due to any cause through Day 29, Proportion of subjects who died due to any cause through Day 29 and Day 60, Proportion of subjects with COVID-19-related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure) through Day 29, Proportion of subjects with COVID-19-related medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit) or who died due to any cause through Day 29 and Day 60, Proportion of subjects with COVID-19 symptom relapse through Day 29, Proportion of subjects with viral load rebound through Day 29, The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	—

Measure

Time frame

Proportion of subjects with COVID-19-related hospitalization or who died due to any cause through Day 29, Proportion of subjects who died due to any cause through Day 29 and Day 60, Proportion of subjects with COVID-19-related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure) through Day 29, Proportion of subjects with COVID-19-related medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit) or who died due to any cause through Day 29 and Day 60, Proportion of subjects with COVID-19 symptom relapse through Day 29, Proportion of subjects with viral load rebound through Day 29, The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

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Countries

Germany, Latvia, Netherlands, Romania, Spain, Sweden

Outcome results

None listed