TriangleNCT04401579 · OUTCOME
Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
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 NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Analysis population: The ITT population includes participants as randomized, and restricted to those with a baseline NEWS score of 2 or greater.
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 | 361 |
| Remdesivir Plus Placebo | 334 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | 6.0 | Not reported | 6.0 | 7.0 | Not reported |
| Remdesivir Plus Placebo | 7.0 | Not reported | 6.0 | 9.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.44
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.003
- param Type
- Cox Proportional Hazard
- param Value
- 1.24
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.44
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.003
- param Type
- Cox Proportional Hazard
- param Value
- 1.24
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 7.0
- value
- 6.0
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 9.0
- value
- 7.0
- denoms
- counts
- group Id
- OG000
- value
- 361
- group Id
- OG001
- value
- 334
- units
- Participants
- description
- The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 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 participants as randomized, and restricted to those with a baseline NEWS score of 2 or greater.
- reporting Status
- POSTED
- time Frame
- Day 1 through Day 29
- title
- Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice