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NCT04401579 · OUTCOME

Change From Baseline in Prothrombin International Normalized Ratio (INR)

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

What was measured

Blood to evaluate INR 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 Baricitinib447
Remdesivir Plus Placebo439

Reported measurements

Day 3

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib447
Remdesivir Plus Placebo439
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.031.13Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.050.59Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib360
Remdesivir Plus Placebo370
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.021.25Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.080.65Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib244
Remdesivir Plus Placebo250
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.010.96Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.080.98Not reportedNot reportedNot reported
Day 11

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib162
Remdesivir Plus Placebo175
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib0.040.65Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.031.04Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib222
Remdesivir Plus Placebo241
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.040.25Not reportedNot reportedNot reported
Remdesivir Plus Placebo-0.080.91Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib232
Remdesivir Plus Placebo232
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-0.120.55Not reportedNot reportedNot reported
Remdesivir Plus Placebo-0.030.99Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.13
        value
        -0.03
      2. group Id
        OG001
        spread
        0.59
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        447
      2. group Id
        OG001
        value
        439
      units
      Participants
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.25
        value
        0.02
      2. group Id
        OG001
        spread
        0.65
        value
        0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        360
      2. group Id
        OG001
        value
        370
      units
      Participants
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.96
        value
        0.01
      2. group Id
        OG001
        spread
        0.98
        value
        0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        244
      2. group Id
        OG001
        value
        250
      units
      Participants
    title
    Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.65
        value
        0.04
      2. group Id
        OG001
        spread
        1.04
        value
        0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        162
      2. group Id
        OG001
        value
        175
      units
      Participants
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.25
        value
        -0.04
      2. group Id
        OG001
        spread
        0.91
        value
        -0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        222
      2. group Id
        OG001
        value
        241
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.55
        value
        -0.12
      2. group Id
        OG001
        spread
        0.99
        value
        -0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        232
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      447
    2. group Id
      OG001
      value
      439
    units
    Participants
description
Blood to evaluate INR 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 Prothrombin International Normalized Ratio (INR)
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice