COVID-19
Conditions
Brief summary
PK parameters (AUC0-12, Cmax, and Ctrough) for ODV metabolite, GS-441524, Incidence of treatment-emergent AEs by Day 35, Incidence of treatment-emergent laboratory abnormalities by Day 35
Detailed description
Time to sustained alleviation of targeted COVID-19 symptoms by Day 35, Change from baseline in SARS-CoV-2 nasal swab viral load at Day 5, Proportion of participants who require supplemental oxygen support (low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation) by Day 35, Assessment of palatability and acceptability scores of each formulation at Day 5, Proportion of participants with concomitant use of medications other than remdesivir and ODV for treatment of COVID-19 by Day 35, Proportion of participants with COVID-19-related hospitalization or all-cause death by Day 35
Interventions
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters (AUC0-12, Cmax, and Ctrough) for ODV metabolite, GS-441524, Incidence of treatment-emergent AEs by Day 35, Incidence of treatment-emergent laboratory abnormalities by Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to sustained alleviation of targeted COVID-19 symptoms by Day 35, Change from baseline in SARS-CoV-2 nasal swab viral load at Day 5, Proportion of participants who require supplemental oxygen support (low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation) by Day 35, Assessment of palatability and acceptability scores of each formulation at Day 5, Proportion of participants with concomitant use of medications other than remdesivir and ODV for treatment of COVID-19 by Day 35, Proportion of participants with COVID-19-related hospitalization or all-cause death by Day 35 | — |
Countries
Bulgaria, Hungary, Italy, Poland, Spain
Outcome results
None listed