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NCT04421027 · OUTCOME

Time to Recovery

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

Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day. NIAID-OS 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: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)

Analysis population: All participants randomly assigned to study intervention.

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 + SOC11.0Not reported10.012.0Not reported
Baricitinib + SOC10.0Not reported9.011.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1453
    param Type
    Hazard Ratio (HR)
    param Value
    1.11
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1453
    param Type
    Hazard Ratio (HR)
    param Value
    1.11
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.0
        upper Limit
        12.0
        value
        11.0
      2. group Id
        OG001
        lower Limit
        9.0
        upper Limit
        11.0
        value
        10.0
denoms
  1. counts
    1. group Id
      OG000
      value
      761
    2. group Id
      OG001
      value
      764
    units
    Participants
description
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day. NIAID-OS 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: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)
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.
reporting Status
POSTED
time Frame
Day 1 to Day 28
title
Time to Recovery
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice