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NCT04401579 · OUTCOME

Change From Baseline in Total Bilirubin

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
mg/dL
Interval / dispersion
Standard Deviation
Time frame
Days 1, 3, 5, 8, 11, 15 and 29

What was measured

Blood to evaluate total bilirubin 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

GroupSource count
Remdesivir Plus Baricitinib490
Remdesivir Plus Placebo491

Reported measurements

Day 3

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib490
Remdesivir Plus Placebo491
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.060.32Not reportedNot reportedNot reported
Remdesivir Plus Placebo-0.010.43Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib407
Remdesivir Plus Placebo405
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.040.37Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.010.42Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib268
Remdesivir Plus Placebo284
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.060.41Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.010.66Not reportedNot reportedNot reported
Day 11

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib187
Remdesivir Plus Placebo201
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.080.43Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.081.19Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib250
Remdesivir Plus Placebo270
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.100.37Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.081.20Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib256
Remdesivir Plus Placebo254
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.100.36Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.010.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.32
        value
        -0.06
      2. group Id
        OG001
        spread
        0.43
        value
        -0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        490
      2. group Id
        OG001
        value
        491
      units
      Participants
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.37
        value
        -0.04
      2. group Id
        OG001
        spread
        0.42
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        407
      2. group Id
        OG001
        value
        405
      units
      Participants
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.41
        value
        -0.06
      2. group Id
        OG001
        spread
        0.66
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        268
      2. group Id
        OG001
        value
        284
      units
      Participants
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.43
        value
        -0.08
      2. group Id
        OG001
        spread
        1.19
        value
        0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      2. group Id
        OG001
        value
        201
      units
      Participants
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.37
        value
        -0.10
      2. group Id
        OG001
        spread
        1.20
        value
        0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        250
      2. group Id
        OG001
        value
        270
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.36
        value
        -0.10
      2. group Id
        OG001
        spread
        0.91
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        256
      2. group Id
        OG001
        value
        254
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      490
    2. group Id
      OG001
      value
      491
    units
    Participants
description
Blood to evaluate total bilirubin 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
  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 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 Total Bilirubin
type
SECONDARY
unit Of Measure
mg/dL

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

Preserved source evidence · Not medical advice