SARS-CoV-2 (COVID-19) infection
Conditions
Brief summary
Percentage of Participants Who Experienced One or More of following through Day 29: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV), Percentage of Participants Who Experienced an Adverse Event (AE), Percentage of Participants Who Discontinued Study Intervention Due to AE
Detailed description
Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms, Change From Baseline in SARS-CoV-2 RNA titer, Percentage of Participants With Undetectable SARS-CoV-2 RNA, Percentage of Participants Who Experienced One or More of following through Day 29: All-cause Hospitalization or All-cause Mortality, Percentage of Participants With Clinically Important Medical Interventions Associated with COVID-19 related MAV or COVID-19 related hospitalization through Day 29, Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29, Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Experienced One or More of following through Day 29: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV), Percentage of Participants Who Experienced an Adverse Event (AE), Percentage of Participants Who Discontinued Study Intervention Due to AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms, Change From Baseline in SARS-CoV-2 RNA titer, Percentage of Participants With Undetectable SARS-CoV-2 RNA, Percentage of Participants Who Experienced One or More of following through Day 29: All-cause Hospitalization or All-cause Mortality, Percentage of Participants With Clinically Important Medical Interventions Associated with COVID-19 related MAV or COVID-19 related hospitalization through Day 29, Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29, Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29 | — |
Countries
Bulgaria, Finland, France, Germany, Italy, Poland, Romania, Spain