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NCT04401579 · OUTCOME

Mean Change in the Ordinal Scale

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 on a scale
Interval / dispersion
Standard Deviation
Time frame
Day 1, 3, 5, 8, 11, 15, 22, and 29

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. A positive change indicates a worsening and a negative change is an improvement.

Analysis population: The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.

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

Day 3
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.10.5Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.10.6Not reportedNot reportedNot reported
Day 5
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.00.7Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.00.7Not reportedNot reportedNot reported
Day 8
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.30.9Not reportedNot reportedNot reported
Remdesivir Plus Placebo-0.10.9Not reportedNot reportedNot reported
Day 11
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.41.0Not reportedNot reportedNot reported
Remdesivir Plus Placebo-0.21.0Not reportedNot reportedNot reported
Day 15
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-2.31.9Not reportedNot reportedNot reported
Remdesivir Plus Placebo-1.92.0Not reportedNot reportedNot reported
Day 22
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-2.71.9Not reportedNot reportedNot reported
Remdesivir Plus Placebo-2.32.1Not reportedNot reportedNot reported
Day 29
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-2.91.9Not reportedNot reportedNot reported
Remdesivir Plus Placebo-2.52.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.5
        value
        0.1
      2. group Id
        OG001
        spread
        0.6
        value
        0.1
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.7
        value
        0.0
      2. group Id
        OG001
        spread
        0.7
        value
        0.0
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9
        value
        -0.3
      2. group Id
        OG001
        spread
        0.9
        value
        -0.1
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0
        value
        -0.4
      2. group Id
        OG001
        spread
        1.0
        value
        -0.2
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.9
        value
        -2.3
      2. group Id
        OG001
        spread
        2.0
        value
        -1.9
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.9
        value
        -2.7
      2. group Id
        OG001
        spread
        2.1
        value
        -2.3
    title
    Day 22
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.9
        value
        -2.9
      2. group Id
        OG001
        spread
        2.1
        value
        -2.5
    title
    Day 29
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. A positive change indicates a worsening and a negative change is an improvement.
dispersion Type
Standard Deviation
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
MEAN
population Description
The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.
reporting Status
POSTED
time Frame
Day 1, 3, 5, 8, 11, 15, 22, and 29
title
Mean Change in the Ordinal Scale
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice