Covid-19 at high risk of progression to severe illness.
Conditions
Brief summary
Proportion of participants with COVID-19-related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg, hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28.
Detailed description
Time (days) to resolution of all targeted symptoms through Day 28., Proportion of participants with CRPE from Day 1 to Week 24, Proportion of participants with PACE occurring from Day 29 to Week 24, Proportion of participants with Long COVID/PASC symptoms at Week 24, based on the Long COVID/PASC PRO.
Interventions
DRUGPlacebo to Ibuzatrelvir film-coated tablet
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with COVID-19-related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg, hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time (days) to resolution of all targeted symptoms through Day 28., Proportion of participants with CRPE from Day 1 to Week 24, Proportion of participants with PACE occurring from Day 29 to Week 24, Proportion of participants with Long COVID/PASC symptoms at Week 24, based on the Long COVID/PASC PRO. | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, Finland, Germany, Slovakia, Spain
Outcome results
None listed