TriangleNCT04401579 · OUTCOME
Change in National Early Warning Score (NEWS) From Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1, 3, 5, 8, 11, 15, 22, and 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.
Analysis population: The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.
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
Day 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -0.5 | 2.5 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -0.1 | 2.6 | Not reported | Not reported | Not reported |
Day 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -0.9 | 2.8 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -0.4 | 2.8 | Not reported | Not reported | Not reported |
Day 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -1.5 | 2.9 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -0.8 | 3.3 | Not reported | Not reported | Not reported |
Day 11
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -1.8 | 3.2 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -1.1 | 3.5 | Not reported | Not reported | Not reported |
Day 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -2.1 | 3.3 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -1.2 | 3.9 | Not reported | Not reported | Not reported |
Day 22
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -2.0 | 3.8 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -1.2 | 4.6 | Not reported | Not reported | Not reported |
Day 29
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Remdesivir Plus Baricitinib | -2.2 | 4.3 | Not reported | Not reported | Not reported |
| Remdesivir Plus Placebo | -1.4 | 5.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.5
- value
- -0.5
- group Id
- OG001
- spread
- 2.6
- value
- -0.1
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 2.8
- value
- -0.9
- group Id
- OG001
- spread
- 2.8
- value
- -0.4
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 2.9
- value
- -1.5
- group Id
- OG001
- spread
- 3.3
- value
- -0.8
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 3.2
- value
- -1.8
- group Id
- OG001
- spread
- 3.5
- value
- -1.1
- title
- Day 11
- categories
- measurements
- group Id
- OG000
- spread
- 3.3
- value
- -2.1
- group Id
- OG001
- spread
- 3.9
- value
- -1.2
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 3.8
- value
- -2.0
- group Id
- OG001
- spread
- 4.6
- value
- -1.2
- title
- Day 22
- categories
- measurements
- group Id
- OG000
- spread
- 4.3
- value
- -2.2
- group Id
- OG001
- spread
- 5.0
- value
- -1.4
- title
- Day 29
- denoms
- counts
- group Id
- OG000
- value
- 515
- group Id
- OG001
- value
- 518
- 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.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.
- reporting Status
- POSTED
- time Frame
- Days 1, 3, 5, 8, 11, 15, 22, and 29
- title
- Change in National Early Warning Score (NEWS) From Baseline
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice