NCT04401579 · OUTCOME
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Adaptive COVID-19 Treatment Trial 2 (ACTT-2) · Source last updated 2022-03-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 15
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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 515 |
|---|
| Remdesivir Plus Placebo | 518 |
|---|
Reported measurements
Death at or before study visit
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 2 | Not reported | 1 | 4 | Not reported |
|---|
| Remdesivir Plus Placebo | 3 | Not reported | 2 | 5 | Not reported |
|---|
Hospitalized, on invasive mech. vent. or ECMO
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 9 | Not reported | 7 | 12 | Not reported |
|---|
| Remdesivir Plus Placebo | 16 | Not reported | 13 | 19 | Not reported |
|---|
Hospitalized, on non-invasive vent./high flow O2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 4 | Not reported | 3 | 6 | Not reported |
|---|
| Remdesivir Plus Placebo | 4 | Not reported | 2 | 6 | Not reported |
|---|
Hospitalized, requiring supplemental oxygen
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 8 | Not reported | 6 | 11 | Not reported |
|---|
| Remdesivir Plus Placebo | 10 | Not reported | 7 | 13 | Not reported |
|---|
Hospitalized, not on O2, requiring ongoing care
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 6 | Not reported | 4 | 8 | Not reported |
|---|
| Remdesivir Plus Placebo | 3 | Not reported | 2 | 5 | Not reported |
|---|
Hospitalized, not requiring O2, no longer req care
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 2 | Not reported | 1 | 3 | Not reported |
|---|
| Remdesivir Plus Placebo | 1 | Not reported | 0 | 2 | Not reported |
|---|
Not hospitalized, limit on activities/req home O2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 34 | Not reported | 30 | 39 | Not reported |
|---|
| Remdesivir Plus Placebo | 31 | Not reported | 28 | 36 | Not reported |
|---|
Not hospitalized, no limitations on activities
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 34 | Not reported | 30 | 39 | Not reported |
|---|
| Remdesivir Plus Placebo | 32 | Not reported | 28 | 36 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 1.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.57
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.44
- param Type
- Odds Ratio (OR)
- param Value
- 1.26
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 1.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.57
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.44
- param Type
- Odds Ratio (OR)
- param Value
- 1.26
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 4
- value
- 2
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 5
- value
- 3
- title
- Death at or before study visit
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7
- upper Limit
- 12
- value
- 9
- group Id
- OG001
- lower Limit
- 13
- upper Limit
- 19
- value
- 16
- title
- Hospitalized, on invasive mech. vent. or ECMO
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 6
- value
- 4
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 6
- value
- 4
- title
- Hospitalized, on non-invasive vent./high flow O2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6
- upper Limit
- 11
- value
- 8
- group Id
- OG001
- lower Limit
- 7
- upper Limit
- 13
- value
- 10
- title
- Hospitalized, requiring supplemental oxygen
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 8
- value
- 6
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 5
- value
- 3
- title
- Hospitalized, not on O2, requiring ongoing care
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 3
- value
- 2
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 2
- value
- 1
- title
- Hospitalized, not requiring O2, no longer req care
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30
- upper Limit
- 39
- value
- 34
- group Id
- OG001
- lower Limit
- 28
- upper Limit
- 36
- value
- 31
- title
- Not hospitalized, limit on activities/req home O2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30
- upper Limit
- 39
- value
- 34
- group Id
- OG001
- lower Limit
- 28
- upper Limit
- 36
- value
- 32
- title
- Not hospitalized, no limitations on activities
- 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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.
- 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
- NUMBER
- population Description
- The intent-to-treat (ITT) population includes all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Day 15
- title
- Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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