NCT04401579 · OUTCOME
Change From Baseline in Alanine Transaminase (ALT)
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
- MEAN
- Unit
- Units/Liter (U/L)
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1, 3, 5, 8, 11, 15 and 29
What was measured
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Analysis population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
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 | 491 |
|---|
| Remdesivir Plus Placebo | 491 |
|---|
Reported measurements
Day 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 491 |
|---|
| Remdesivir Plus Placebo | 491 |
|---|
Values in Units/Liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 3.3 | 37.1 | Not reported | Not reported | Not reported |
|---|
| Remdesivir Plus Placebo | 2.0 | 30.1 | Not reported | Not reported | Not reported |
|---|
Day 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 407 |
|---|
| Remdesivir Plus Placebo | 406 |
|---|
Values in Units/Liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 16.8 | 104.4 | Not reported | Not reported | Not reported |
|---|
| Remdesivir Plus Placebo | 8.8 | 40.9 | Not reported | Not reported | Not reported |
|---|
Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 268 |
|---|
| Remdesivir Plus Placebo | 284 |
|---|
Values in Units/Liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 7.9 | 45.2 | Not reported | Not reported | Not reported |
|---|
| Remdesivir Plus Placebo | 7.8 | 46.9 | Not reported | Not reported | Not reported |
|---|
Day 11
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 187 |
|---|
| Remdesivir Plus Placebo | 201 |
|---|
Values in Units/Liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 0.0 | 37.5 | Not reported | Not reported | Not reported |
|---|
| Remdesivir Plus Placebo | 7.3 | 70.2 | Not reported | Not reported | Not reported |
|---|
Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 250 |
|---|
| Remdesivir Plus Placebo | 270 |
|---|
Values in Units/Liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 5.0 | 61.5 | Not reported | Not reported | Not reported |
|---|
| Remdesivir Plus Placebo | 3.9 | 55.1 | Not reported | Not reported | Not reported |
|---|
Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Remdesivir Plus Baricitinib | 256 |
|---|
| Remdesivir Plus Placebo | 255 |
|---|
Values in Units/Liter (U/L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | -5.4 | 43.0 | Not reported | Not reported | Not reported |
|---|
| Remdesivir Plus Placebo | 2.3 | 116.1 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 37.1
- value
- 3.3
- group Id
- OG001
- spread
- 30.1
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 491
- group Id
- OG001
- value
- 491
- units
- Participants
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 104.4
- value
- 16.8
- group Id
- OG001
- spread
- 40.9
- value
- 8.8
- denoms
- counts
- group Id
- OG000
- value
- 407
- group Id
- OG001
- value
- 406
- units
- Participants
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 45.2
- value
- 7.9
- group Id
- OG001
- spread
- 46.9
- value
- 7.8
- denoms
- counts
- group Id
- OG000
- value
- 268
- group Id
- OG001
- value
- 284
- units
- Participants
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 37.5
- value
- 0.0
- group Id
- OG001
- spread
- 70.2
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 201
- units
- Participants
- title
- Day 11
- categories
- measurements
- group Id
- OG000
- spread
- 61.5
- value
- 5.0
- group Id
- OG001
- spread
- 55.1
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 250
- group Id
- OG001
- value
- 270
- units
- Participants
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 43.0
- value
- -5.4
- group Id
- OG001
- spread
- 116.1
- value
- 2.3
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 255
- units
- Participants
- title
- Day 29
- denoms
- counts
- group Id
- OG000
- value
- 491
- group Id
- OG001
- value
- 491
- units
- Participants
- description
- Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
- 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 safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
- reporting Status
- POSTED
- time Frame
- Days 1, 3, 5, 8, 11, 15 and 29
- title
- Change From Baseline in Alanine Transaminase (ALT)
- type
- SECONDARY
- unit Of Measure
- Units/Liter (U/L)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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