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NCT04401579 · OUTCOME

Change From Baseline in Glucose

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

What was measured

Blood to evaluate serum glucose 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 Placebo493

Reported measurements

Day 3

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib493
Remdesivir Plus Placebo493
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-17.156.4Not reportedNot reportedNot reported
Remdesivir Plus Placebo-6.054.0Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib412
Remdesivir Plus Placebo409
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-15.959.7Not reportedNot reportedNot reported
Remdesivir Plus Placebo-1.658.4Not reportedNot reportedNot reported
Day 8

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib270
Remdesivir Plus Placebo284
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-16.878.9Not reportedNot reportedNot reported
Remdesivir Plus Placebo5.073.7Not reportedNot reportedNot reported
Day 11

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib190
Remdesivir Plus Placebo203
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-8.172.3Not reportedNot reportedNot reported
Remdesivir Plus Placebo1.266.2Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib252
Remdesivir Plus Placebo271
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-11.169.8Not reportedNot reportedNot reported
Remdesivir Plus Placebo0.868.3Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Remdesivir Plus Baricitinib257
Remdesivir Plus Placebo256
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Remdesivir Plus Baricitinib-4.666.5Not reportedNot reportedNot reported
Remdesivir Plus Placebo-2.260.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.4
        value
        -17.1
      2. group Id
        OG001
        spread
        54.0
        value
        -6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        493
      2. group Id
        OG001
        value
        493
      units
      Participants
    title
    Day 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.7
        value
        -15.9
      2. group Id
        OG001
        spread
        58.4
        value
        -1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        412
      2. group Id
        OG001
        value
        409
      units
      Participants
    title
    Day 5
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.9
        value
        -16.8
      2. group Id
        OG001
        spread
        73.7
        value
        5.0
    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
        72.3
        value
        -8.1
      2. group Id
        OG001
        spread
        66.2
        value
        1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      2. group Id
        OG001
        value
        203
      units
      Participants
    title
    Day 11
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.8
        value
        -11.1
      2. group Id
        OG001
        spread
        68.3
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        252
      2. group Id
        OG001
        value
        271
      units
      Participants
    title
    Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.5
        value
        -4.6
      2. group Id
        OG001
        spread
        60.3
        value
        -2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        257
      2. group Id
        OG001
        value
        256
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      493
    2. group Id
      OG001
      value
      493
    units
    Participants
description
Blood to evaluate serum glucose 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 Glucose
type
SECONDARY
unit Of Measure
mg/dL

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

Preserved source evidence · Not medical advice