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NCT04401579 · OUTCOME

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22

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 22

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.

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

Death at or before study Visit
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib4Not reported36Not reported
Remdesivir Plus Placebo6Not reported59Not reported
Hospitalized, on invasive mech. vent. or ECMO
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib6Not reported48Not reported
Remdesivir Plus Placebo9Not reported712Not reported
Hospitalized, on non-invasive vent./high flow O2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib3Not reported25Not reported
Remdesivir Plus Placebo1Not reported13Not reported
Hospitalized, requiring supplemental oxygen
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib3Not reported25Not reported
Remdesivir Plus Placebo5Not reported37Not reported
Hospitalized, not on O2, requiring ongoing care
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib2Not reported14Not reported
Remdesivir Plus Placebo3Not reported14Not reported
Hospitalized, not requiring O2, no longer req care
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib1Not reported13Not reported
Remdesivir Plus Placebo0.4Not reported01Not reported
Not hospitalized, limit on activities/req home O2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib24Not reported2128Not reported
Remdesivir Plus Placebo25Not reported2129Not reported
Not hospitalized, no limitations on activities
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib44Not reported4049Not reported
Remdesivir Plus Placebo37Not reported3342Not reported
No clinical status score reported - Hospitalized
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0Not reported01Not reported
Remdesivir Plus Placebo0Not reported01Not reported
No clinical status score reported - Discharged
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib4Not reported26Not reported
Remdesivir Plus Placebo3Not reported25Not reported
No clinical status score reported - Discontinued
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib9Not reported611Not reported
Remdesivir Plus Placebo10Not reported813Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        6
        value
        4
      2. group Id
        OG001
        lower Limit
        5
        upper Limit
        9
        value
        6
    title
    Death at or before study Visit
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4
        upper Limit
        8
        value
        6
      2. group Id
        OG001
        lower Limit
        7
        upper Limit
        12
        value
        9
    title
    Hospitalized, on invasive mech. vent. or ECMO
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        5
        value
        3
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        3
        value
        1
    title
    Hospitalized, on non-invasive vent./high flow O2
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        5
        value
        3
      2. group Id
        OG001
        lower Limit
        3
        upper Limit
        7
        value
        5
    title
    Hospitalized, requiring supplemental oxygen
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        4
        value
        2
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        4
        value
        3
    title
    Hospitalized, not on O2, requiring ongoing care
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        3
        value
        1
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1
        value
        0.4
    title
    Hospitalized, not requiring O2, no longer req care
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21
        upper Limit
        28
        value
        24
      2. group Id
        OG001
        lower Limit
        21
        upper Limit
        29
        value
        25
    title
    Not hospitalized, limit on activities/req home O2
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40
        upper Limit
        49
        value
        44
      2. group Id
        OG001
        lower Limit
        33
        upper Limit
        42
        value
        37
    title
    Not hospitalized, no limitations on activities
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1
        value
        0
    title
    No clinical status score reported - Hospitalized
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        6
        value
        4
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        5
        value
        3
    title
    No clinical status score reported - Discharged
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        11
        value
        9
      2. group Id
        OG001
        lower Limit
        8
        upper Limit
        13
        value
        10
    title
    No clinical status score reported - Discontinued
denoms
  1. counts
    1. group Id
      OG000
      value
      515
    2. 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.
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
NUMBER
population Description
The intent-to-treat (ITT) population includes all participants who were randomized
reporting Status
POSTED
time Frame
Day 22
title
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice