COVID-19
Conditions
Brief summary
The primary outcome for this trial is called the "Days to Recovery Scale" assessed over 60 days (DRS-60). DRS-60 is a version of the STRIVE clinical recovery scale (CRS) that is described in the master protocol, which combines time to recovery with non-recovered clinical state and death into an ordinal outcome. For this trial, the DRS-60 version of the CRS includes daily bins for time to recovery with additional categories for alive, not-recovered and death.
Detailed description
Mortality (proportion of participants who died by Day 60), 3-category ordinal outcome (recovered, alive but not recovered, dead), Time to recovery, Death or new requirement for invasive mechanical ventilation, Safety as measured by composite of death, Serious Adverse Events, protocol-defined anticipated clinical events, grade 3 Adverse Events, grade 4 Adverse Events
Interventions
Sponsors
University Of Minnesota
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for this trial is called the "Days to Recovery Scale" assessed over 60 days (DRS-60). DRS-60 is a version of the STRIVE clinical recovery scale (CRS) that is described in the master protocol, which combines time to recovery with non-recovered clinical state and death into an ordinal outcome. For this trial, the DRS-60 version of the CRS includes daily bins for time to recovery with additional categories for alive, not-recovered and death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality (proportion of participants who died by Day 60), 3-category ordinal outcome (recovered, alive but not recovered, dead), Time to recovery, Death or new requirement for invasive mechanical ventilation, Safety as measured by composite of death, Serious Adverse Events, protocol-defined anticipated clinical events, grade 3 Adverse Events, grade 4 Adverse Events | — |
Countries
Cyprus, Denmark, France, Germany, Greece, Ireland, Poland, Spain, Sweden
Outcome results
None listed