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NCT04421027 · OUTCOME

Time to Resolution of Fever in Participants With Fever at Baseline

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

Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (\<65 years, \>=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).

Analysis population: All participants randomly assigned to study intervention who had a fever at baseline.

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 + SOC354
Baricitinib + SOC357

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + SOC4.00Not reported3.004.00Not reported
Baricitinib + SOC3.00Not reported3.004.00Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.017
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.421
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0243
    param Type
    Hazard Ratio (HR)
    param Value
    1.202
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.017
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.421
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0243
    param Type
    Hazard Ratio (HR)
    param Value
    1.202
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.00
        upper Limit
        4.00
        value
        4.00
      2. group Id
        OG001
        lower Limit
        3.00
        upper Limit
        4.00
        value
        3.00
denoms
  1. counts
    1. group Id
      OG000
      value
      354
    2. group Id
      OG001
      value
      357
    units
    Participants
description
Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (\<65 years, \>=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).
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 who had a fever at baseline.
reporting Status
POSTED
time Frame
Day 1 to Day 28
title
Time to Resolution of Fever in Participants With Fever at Baseline
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice