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NCT04401579 · OUTCOME

Change From Baseline in White Blood Cell Count (WBC)

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
10^9 cells/liter
Interval / dispersion
Standard Deviation
Time frame
Days 1, 3, 5, 8, 11, 15 and 29

What was measured

Blood to evaluate WBC 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 Baricitinib493
Remdesivir Plus Placebo494

Reported measurements

Day 3

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib493
Remdesivir Plus Placebo494
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.8313.020Not reportedNot reportedNot reported
Remdesivir Plus Placebo-0.0372.588Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib410
Remdesivir Plus Placebo409
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.2763.399Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.3923.238Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib270
Remdesivir Plus Placebo284
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.6634.006Not reportedNot reportedNot reported
Remdesivir Plus Placebo1.6064.536Not reportedNot reportedNot reported
Day 11

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib189
Remdesivir Plus Placebo199
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib1.8695.683Not reportedNot reportedNot reported
Remdesivir Plus Placebo2.9385.419Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib253
Remdesivir Plus Placebo267
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.6945.125Not reportedNot reportedNot reported
Remdesivir Plus Placebo2.1625.741Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib260
Remdesivir Plus Placebo254
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.3644.532Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.7124.176Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.020
        value
        -0.831
      2. group Id
        OG001
        spread
        2.588
        value
        -0.037
    denoms
    1. counts
      1. group Id
        OG000
        value
        493
      2. group Id
        OG001
        value
        494
      units
      Participants
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.399
        value
        -0.276
      2. group Id
        OG001
        spread
        3.238
        value
        0.392
    denoms
    1. counts
      1. group Id
        OG000
        value
        410
      2. group Id
        OG001
        value
        409
      units
      Participants
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.006
        value
        0.663
      2. group Id
        OG001
        spread
        4.536
        value
        1.606
    denoms
    1. counts
      1. group Id
        OG000
        value
        270
      2. group Id
        OG001
        value
        284
      units
      Participants
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.683
        value
        1.869
      2. group Id
        OG001
        spread
        5.419
        value
        2.938
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        199
      units
      Participants
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.125
        value
        0.694
      2. group Id
        OG001
        spread
        5.741
        value
        2.162
    denoms
    1. counts
      1. group Id
        OG000
        value
        253
      2. group Id
        OG001
        value
        267
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.532
        value
        -0.364
      2. group Id
        OG001
        spread
        4.176
        value
        0.712
    denoms
    1. counts
      1. group Id
        OG000
        value
        260
      2. group Id
        OG001
        value
        254
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      493
    2. group Id
      OG001
      value
      494
    units
    Participants
description
Blood to evaluate WBC 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 White Blood Cell Count (WBC)
type
SECONDARY
unit Of Measure
10^9 cells/liter

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

Preserved source evidence · Not medical advice