Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Sponsor
University Hospital of Patras
Study ID
NCT05082714
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)
  • Baricitinib — DRUG
    The baricitinib intervention consists of baricitinib at a dose of 4 mg/day (given daily for up to 14 days or until discharge from hospital, whichever occurred first); however, 2 mg/day will be given if the patient has a baseline eGFR of 30 to less than 60 mL/min/1·73 m2

Study Details

The aim of this study is to investigate whether baricitinib is non-inferior to tocilizumab in severe COVID-19.

Key Dates

Start date
Oct 20, 2021
Status verified
Nov 2023
Primary completion
Jun 4, 2022
Completion
Jun 4, 2022

Study Design

Enrollment
251 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tocilizumab
    tocilizumab plus usual care
  • Experimental: baricitinib
    baricitinib plus usual care

Primary Outcome Measure

Mechanical ventilation or death by day 28 [ Time Frame: day 28 ]

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