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NCT04421027 · OUTCOME

Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital

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 10

What was measured

The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.

Analysis population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.

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 + SOC756
Baricitinib + SOC762

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + SOC63.5Not reported60.167.0Not reported
Baricitinib + SOC65.0Not reported61.668.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.34
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5444
    param Type
    Odds Ratio (OR)
    param Value
    1.07
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.34
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5444
    param Type
    Odds Ratio (OR)
    param Value
    1.07
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        60.1
        upper Limit
        67.0
        value
        63.5
      2. group Id
        OG001
        lower Limit
        61.6
        upper Limit
        68.5
        value
        65.0
denoms
  1. counts
    1. group Id
      OG000
      value
      756
    2. group Id
      OG001
      value
      762
    units
    Participants
description
The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.
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. Participants with missing baseline ordinal scale values were excluded.
reporting Status
POSTED
time Frame
Day 10
title
Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice