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NCT04401579 · OUTCOME

Change From Baseline in C-reactive Protein (CRP)

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

What was measured

Blood to evaluate CRP 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 Baricitinib446
Remdesivir Plus Placebo455

Reported measurements

Day 3

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib446
Remdesivir Plus Placebo455
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-23.035169.442Not reportedNot reportedNot reported
Remdesivir Plus Placebo-18.671102.661Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib368
Remdesivir Plus Placebo367
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-58.935110.364Not reportedNot reportedNot reported
Remdesivir Plus Placebo-30.908150.076Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib241
Remdesivir Plus Placebo250
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-78.411104.943Not reportedNot reportedNot reported
Remdesivir Plus Placebo-62.038125.254Not reportedNot reportedNot reported
Day 11

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib159
Remdesivir Plus Placebo181
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-103.789124.751Not reportedNot reportedNot reported
Remdesivir Plus Placebo-88.881159.184Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib221
Remdesivir Plus Placebo240
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-122.339110.502Not reportedNot reportedNot reported
Remdesivir Plus Placebo-112.588155.762Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib217
Remdesivir Plus Placebo219
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-131.333115.243Not reportedNot reportedNot reported
Remdesivir Plus Placebo-122.342268.733Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        169.442
        value
        -23.035
      2. group Id
        OG001
        spread
        102.661
        value
        -18.671
    denoms
    1. counts
      1. group Id
        OG000
        value
        446
      2. group Id
        OG001
        value
        455
      units
      Participants
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        110.364
        value
        -58.935
      2. group Id
        OG001
        spread
        150.076
        value
        -30.908
    denoms
    1. counts
      1. group Id
        OG000
        value
        368
      2. group Id
        OG001
        value
        367
      units
      Participants
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        104.943
        value
        -78.411
      2. group Id
        OG001
        spread
        125.254
        value
        -62.038
    denoms
    1. counts
      1. group Id
        OG000
        value
        241
      2. group Id
        OG001
        value
        250
      units
      Participants
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        124.751
        value
        -103.789
      2. group Id
        OG001
        spread
        159.184
        value
        -88.881
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        181
      units
      Participants
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        110.502
        value
        -122.339
      2. group Id
        OG001
        spread
        155.762
        value
        -112.588
    denoms
    1. counts
      1. group Id
        OG000
        value
        221
      2. group Id
        OG001
        value
        240
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        115.243
        value
        -131.333
      2. group Id
        OG001
        spread
        268.733
        value
        -122.342
    denoms
    1. counts
      1. group Id
        OG000
        value
        217
      2. group Id
        OG001
        value
        219
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      446
    2. group Id
      OG001
      value
      455
    units
    Participants
description
Blood to evaluate CRP 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 C-reactive Protein (CRP)
type
SECONDARY
unit Of Measure
mg/L

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

Preserved source evidence · Not medical advice