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NCT04401579 · OUTCOME

Change From Baseline in Lymphocytes

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 lymphocytes 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 Baricitinib488
Remdesivir Plus Placebo493

Reported measurements

Day 3

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib488
Remdesivir Plus Placebo493
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.5032.290Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.0743.844Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib408
Remdesivir Plus Placebo404
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.6202.540Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.2053.838Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib268
Remdesivir Plus Placebo282
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.5152.094Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.3041.366Not reportedNot reportedNot reported
Day 11

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib186
Remdesivir Plus Placebo196
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.5411.204Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.4090.709Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib249
Remdesivir Plus Placebo267
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.6871.579Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.7181.684Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib257
Remdesivir Plus Placebo253
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.6531.293Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.9271.996Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.290
        value
        0.503
      2. group Id
        OG001
        spread
        3.844
        value
        0.074
    denoms
    1. counts
      1. group Id
        OG000
        value
        488
      2. group Id
        OG001
        value
        493
      units
      Participants
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.540
        value
        0.620
      2. group Id
        OG001
        spread
        3.838
        value
        0.205
    denoms
    1. counts
      1. group Id
        OG000
        value
        408
      2. group Id
        OG001
        value
        404
      units
      Participants
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.094
        value
        0.515
      2. group Id
        OG001
        spread
        1.366
        value
        0.304
    denoms
    1. counts
      1. group Id
        OG000
        value
        268
      2. group Id
        OG001
        value
        282
      units
      Participants
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.204
        value
        0.541
      2. group Id
        OG001
        spread
        0.709
        value
        0.409
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        196
      units
      Participants
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.579
        value
        0.687
      2. group Id
        OG001
        spread
        1.684
        value
        0.718
    denoms
    1. counts
      1. group Id
        OG000
        value
        249
      2. group Id
        OG001
        value
        267
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.293
        value
        0.653
      2. group Id
        OG001
        spread
        1.996
        value
        0.927
    denoms
    1. counts
      1. group Id
        OG000
        value
        257
      2. group Id
        OG001
        value
        253
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      488
    2. group Id
      OG001
      value
      493
    units
    Participants
description
Blood to evaluate lymphocytes 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 Lymphocytes
type
SECONDARY
unit Of Measure
10^9 cells/liter

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

Preserved source evidence · Not medical advice