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NCT04421027 · OUTCOME

Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2

A Study of Baricitinib (LY3009104) in Participants With COVID-19 · Source last updated 2022-07-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 to Day 28

What was measured

Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.

Analysis population: All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition.

Groups in this outcome

Placebo + SOC

Placebo administered orally QD with standard of care.

Baricitinib + SOC

4 mg baricitinib administered orally QD with standard of care.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo + SOC109
Baricitinib + SOC96

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + SOC27.1Not reported18.735.6Not reported
Baricitinib + SOC28.9Not reported19.638.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7280
    param Type
    Odds Ratio (OR)
    param Value
    1.12
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7280
    param Type
    Odds Ratio (OR)
    param Value
    1.12
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.7
        upper Limit
        35.6
        value
        27.1
      2. group Id
        OG001
        lower Limit
        19.6
        upper Limit
        38.2
        value
        28.9
denoms
  1. counts
    1. group Id
      OG000
      value
      109
    2. group Id
      OG001
      value
      96
    units
    Participants
description
Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.
dispersion Type
95% Confidence Interval
groups
  1. description
    Placebo administered orally QD with standard of care.
    id
    OG000
    title
    Placebo + SOC
  2. description
    4 mg baricitinib administered orally QD with standard of care.
    id
    OG001
    title
    Baricitinib + SOC
param Type
NUMBER
population Description
All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition.
reporting Status
POSTED
time Frame
Day 1 to Day 28
title
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice