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NCT04401579 · OUTCOME

Time to Recovery by Race

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
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 through Day 29

What was measured

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

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

GroupSource count
Remdesivir Plus Baricitinib515
Remdesivir Plus Placebo518

Reported measurements

Asian

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib49
Remdesivir Plus Placebo52
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib10Not reported7.013.0Not reported
Remdesivir Plus Placebo10.0Not reported9.013.0Not reported
Black or African American

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib77
Remdesivir Plus Placebo79
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib7.0Not reported5.08.0Not reported
Remdesivir Plus Placebo6.0Not reported5.08.0Not reported
White

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib251
Remdesivir Plus Placebo245
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib7.0Not reported5.08.0Not reported
Remdesivir Plus Placebo7.0Not reported6.09.0Not reported
Other

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib138
Remdesivir Plus Placebo142
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib7.0Not reported6.08.0Not reported
Remdesivir Plus Placebo8.0Not reported6.011.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    group Description
    This analysis is for Asian participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.11
  2. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.50
    group Description
    This analysis is for Black or African American participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.06
  3. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    group Description
    This analysis is for White participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.13
  4. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.74
    group Description
    This analysis is for Race of Other participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.34
Complete source fields
analyses
  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    group Description
    This analysis is for Asian participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.11
  2. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.50
    group Description
    This analysis is for Black or African American participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.06
  3. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    group Description
    This analysis is for White participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.13
  4. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.74
    group Description
    This analysis is for Race of Other participants.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.34
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        13.0
        value
        10
      2. group Id
        OG001
        lower Limit
        9.0
        upper Limit
        13.0
        value
        10.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    Asian
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.0
        upper Limit
        8.0
        value
        7.0
      2. group Id
        OG001
        lower Limit
        5.0
        upper Limit
        8.0
        value
        6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        79
      units
      Participants
    title
    Black or African American
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.0
        upper Limit
        8.0
        value
        7.0
      2. group Id
        OG001
        lower Limit
        6.0
        upper Limit
        9.0
        value
        7.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        251
      2. group Id
        OG001
        value
        245
      units
      Participants
    title
    White
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.0
        upper Limit
        8.0
        value
        7.0
      2. group Id
        OG001
        lower Limit
        6.0
        upper Limit
        11.0
        value
        8.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        142
      units
      Participants
    title
    Other
denoms
  1. counts
    1. group Id
      OG000
      value
      515
    2. group Id
      OG001
      value
      518
    units
    Participants
description
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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 intent-to-treat (ITT) population includes all participants who were randomized
reporting Status
POSTED
time Frame
Day 1 through Day 29
title
Time to Recovery by Race
type
PRIMARY
unit Of Measure
Days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice