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NCT04401579 · OUTCOME

Change From Baseline in Platelets

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 platelets 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 Baricitinib55.954.0Not reportedNot reportedNot reported
Remdesivir Plus Placebo52.651.6Not 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 Baricitinib116.687.8Not reportedNot reportedNot reported
Remdesivir Plus Placebo106.186.9Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib269
Remdesivir Plus Placebo284
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib197.9137.4Not reportedNot reportedNot reported
Remdesivir Plus Placebo158.9128.5Not 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 Baricitinib229.9156.0Not reportedNot reportedNot reported
Remdesivir Plus Placebo145.7146.4Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib252
Remdesivir Plus Placebo267
Values in 10^9 cells/liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib175.9158.8Not reportedNot reportedNot reported
Remdesivir Plus Placebo111.6134.9Not 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 Baricitinib16.595.8Not reportedNot reportedNot reported
Remdesivir Plus Placebo36.9107.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.0
        value
        55.9
      2. group Id
        OG001
        spread
        51.6
        value
        52.6
    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
        87.8
        value
        116.6
      2. group Id
        OG001
        spread
        86.9
        value
        106.1
    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
        137.4
        value
        197.9
      2. group Id
        OG001
        spread
        128.5
        value
        158.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        269
      2. group Id
        OG001
        value
        284
      units
      Participants
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        156.0
        value
        229.9
      2. group Id
        OG001
        spread
        146.4
        value
        145.7
    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
        158.8
        value
        175.9
      2. group Id
        OG001
        spread
        134.9
        value
        111.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        252
      2. group Id
        OG001
        value
        267
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        95.8
        value
        16.5
      2. group Id
        OG001
        spread
        107.9
        value
        36.9
    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 platelets 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 Platelets
type
SECONDARY
unit Of Measure
10^9 cells/liter

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

Preserved source evidence · Not medical advice