TriangleNCT04401579 · OUTCOME
Time to Recovery by Sex
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 through Day 29
What was measured
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Analysis population: The intent-to-treat (ITT) population includes all participants who were randomized
Groups in this outcome
Remdesivir Plus Baricitinib
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
Remdesivir Plus Placebo
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
| Group | Source count |
|---|---|
| Remdesivir Plus Baricitinib | 515 |
| Remdesivir Plus Placebo | 518 |
Reported measurements
Male
| Group | Source count |
|---|---|
| Remdesivir Plus Baricitinib | 319 |
| Remdesivir Plus Placebo | 333 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | 7.0 | Not reported | 6.0 | 8.0 | Not reported |
| Remdesivir Plus Placebo | 9.0 | Not reported | 7.0 | 11.0 | Not reported |
Female
| Group | Source count |
|---|---|
| Remdesivir Plus Baricitinib | 196 |
| Remdesivir Plus Placebo | 185 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | 7.0 | Not reported | 6.0 | 8.0 | Not reported |
| Remdesivir Plus Placebo | 7.0 | Not reported | 6.0 | 7.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.46
- group Description
- This analysis is for Male participants.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.23
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.32
- group Description
- This analysis is for Female participants.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.06
Complete source fields
- analyses
- ci Lower Limit
- 1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.46
- group Description
- This analysis is for Male participants.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.23
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.32
- group Description
- This analysis is for Female participants.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Cox Proportional Hazard
- param Value
- 1.06
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 8.0
- value
- 7.0
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 11.0
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 319
- group Id
- OG001
- value
- 333
- units
- Participants
- title
- Male
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 8.0
- value
- 7.0
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 7.0
- value
- 7.0
- denoms
- counts
- group Id
- OG000
- value
- 196
- group Id
- OG001
- value
- 185
- units
- Participants
- title
- Female
- denoms
- counts
- group Id
- OG000
- value
- 515
- group Id
- OG001
- value
- 518
- units
- Participants
- description
- Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
- id
- OG000
- title
- Remdesivir Plus Baricitinib
- description
- 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
- id
- OG001
- title
- Remdesivir Plus Placebo
- param Type
- MEDIAN
- population Description
- The intent-to-treat (ITT) population includes all participants who were randomized
- reporting Status
- POSTED
- time Frame
- Day 1 through Day 29
- title
- Time to Recovery by Sex
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice