TriangleNCT04401579 · OUTCOME
Time to an Improvement of Two Categories Using an Ordinal Scale
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
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
Analysis population: The ITT population includes all participants as 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | 12.0 | Not reported | 12.0 | 13.0 | Not reported |
| Remdesivir Plus Placebo | 13.0 | Not reported | NA | NA | Due to a large number of subjects improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval |
Source statistical analyses
- ci Lower Limit
- 1.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.38
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.005
- param Type
- Cox Proportional Hazard
- param Value
- 1.20
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.38
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.005
- param Type
- Cox Proportional Hazard
- param Value
- 1.20
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 13.0
- value
- 12.0
- comment
- Due to a large number of subjects improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 13.0
- denoms
- counts
- group Id
- OG000
- value
- 515
- group Id
- OG001
- value
- 518
- units
- Participants
- description
- The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
- 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 ITT population includes all participants as randomized
- reporting Status
- POSTED
- time Frame
- Day 1 through Day 29
- title
- Time to an Improvement of Two Categories Using an Ordinal Scale
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice