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NCT04421027 · OUTCOME

Time to Clinical Deterioration (One-category Increase on the NIAID-OS)

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
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 to Day 28

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. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.

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

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 + SOC761
Baricitinib + SOC764

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + SOCNANot reportedNANAMedian not evaluable due to less than half the participants meeting criteria.
Baricitinib + SOCNANot reportedNANAMedian not evaluable due to less than half the participants meeting criteria.

Source statistical analyses

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

  1. ci Lower Limit
    0.741
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.061
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1831
    param Type
    Hazard Ratio (HR)
    param Value
    0.887
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.741
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.061
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1831
    param Type
    Hazard Ratio (HR)
    param Value
    0.887
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median not evaluable due to less than half the participants meeting criteria.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median not evaluable due to less than half the participants meeting criteria.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      761
    2. group Id
      OG001
      value
      764
    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. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.
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
MEDIAN
population Description
All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.
reporting Status
POSTED
time Frame
Day 1 to Day 28
title
Time to Clinical Deterioration (One-category Increase on the NIAID-OS)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice