NCT04401579 · OUTCOME
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
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 1 through Day 14
What was measured
Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.
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
Received less than 10 Infusions of Remdesivir due to Discharge
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 55 | Not reported | 50 | 59 | Not reported |
|---|
| Remdesivir Plus Placebo | 51 | Not reported | 47 | 55 | Not reported |
|---|
Received less than 10 Infusions of Remdesivir due to Death
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 0 | Not reported | 0 | 1 | Not reported |
|---|
| Remdesivir Plus Placebo | 1 | Not reported | 0 | 2 | Not reported |
|---|
Received less than 14 doses of Baricitinib/Placebo due to Discharge
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 66 | Not reported | 62 | 70 | Not reported |
|---|
| Remdesivir Plus Placebo | 59 | Not reported | 55 | 64 | Not reported |
|---|
Received less than 14 doses of Baricitinib/Placebo due to Death
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 0 | Not reported | 0 | 1 | Not reported |
|---|
| Remdesivir Plus Placebo | 1 | Not reported | 1 | 3 | Not reported |
|---|
Had Any Infusions of Remdesivir Halted or Slowed
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 | 2 | Not reported | 1 | 3 | Not reported |
|---|
Had Any Oral Doses of Baricitinib/Placebo Modified
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 16 | Not reported | 13 | 20 | Not reported |
|---|
| Remdesivir Plus Placebo | 18 | Not reported | 14 | 21 | Not reported |
|---|
Missed Any Maintenance Dose of Remdesivir
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 23 | Not reported | 20 | 27 | Not reported |
|---|
| Remdesivir Plus Placebo | 27 | Not reported | 23 | 31 | Not reported |
|---|
Missed Any Oral Dose of Baricitinib/Placebo
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 30 | Not reported | 26 | 34 | Not reported |
|---|
| Remdesivir Plus Placebo | 34 | Not reported | 30 | 38 | Not reported |
|---|
Terminated Early Prior to Completing 10 Infusions of Remdesivir
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 3 | Not reported | 2 | 5 | Not reported |
|---|
| Remdesivir Plus Placebo | 4 | Not reported | 3 | 6 | Not reported |
|---|
Terminated Early Prior to Completing 14 doses of Baricitinib/Placebo
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Remdesivir Plus Baricitinib | 4 | Not reported | 2 | 6 | Not reported |
|---|
| Remdesivir Plus Placebo | 5 | Not reported | 3 | 7 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50
- upper Limit
- 59
- value
- 55
- group Id
- OG001
- lower Limit
- 47
- upper Limit
- 55
- value
- 51
- title
- Received less than 10 Infusions of Remdesivir due to Discharge
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 1
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 2
- value
- 1
- title
- Received less than 10 Infusions of Remdesivir due to Death
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62
- upper Limit
- 70
- value
- 66
- group Id
- OG001
- lower Limit
- 55
- upper Limit
- 64
- value
- 59
- title
- Received less than 14 doses of Baricitinib/Placebo due to Discharge
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 1
- value
- 0
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 3
- value
- 1
- title
- Received less than 14 doses of Baricitinib/Placebo due to Death
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 4
- value
- 2
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 3
- value
- 2
- title
- Had Any Infusions of Remdesivir Halted or Slowed
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13
- upper Limit
- 20
- value
- 16
- group Id
- OG001
- lower Limit
- 14
- upper Limit
- 21
- value
- 18
- title
- Had Any Oral Doses of Baricitinib/Placebo Modified
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20
- upper Limit
- 27
- value
- 23
- group Id
- OG001
- lower Limit
- 23
- upper Limit
- 31
- value
- 27
- title
- Missed Any Maintenance Dose of Remdesivir
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26
- upper Limit
- 34
- value
- 30
- group Id
- OG001
- lower Limit
- 30
- upper Limit
- 38
- value
- 34
- title
- Missed Any Oral Dose of Baricitinib/Placebo
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 5
- value
- 3
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 6
- value
- 4
- title
- Terminated Early Prior to Completing 10 Infusions of Remdesivir
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 6
- value
- 4
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 7
- value
- 5
- title
- Terminated Early Prior to Completing 14 doses of Baricitinib/Placebo
- denoms
- counts
- group Id
- OG000
- value
- 515
- group Id
- OG001
- value
- 518
- units
- Participants
- description
- Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.
- 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 1 through Day 14
- title
- Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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