Tocilizumab Versus Baricitinib in Patients With Severe COVID-19
NCT ID: NCT05082714
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
251 participants
INTERVENTIONAL
2021-10-20
2022-06-04
Brief Summary
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Detailed Description
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Day 1 will be considered the first day that PaO2/FiO2\<200 will be identified. Treatment with either tocilizumab or baricitinib will start from day 1. Primary and secondary outcomes will be assessed in the days described below.
This study aims to investigate whether baricitinib is non-inferior to tocilizumab in patients with severe COVID-19. Two hundred fifty one (n=251) patients will be enrolled based on the following assumptions: 1) HR θ 1, 2) HR θο 1.5, 3) overall probability of event (primary end point) 0.6 (based on previous records of our hospital), 4) power 80%, 5) type I error α 5%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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tocilizumab
tocilizumab plus usual care
Tocilizumab
tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)
baricitinib
baricitinib plus usual care
Baricitinib
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
Interventions
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Tocilizumab
tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)
Baricitinib
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital of Patras
OTHER
Responsible Party
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Argyris Tzouvelekis
Associate Professor of Respiratory Medicine, Head Department of Respiratory Medicine
Locations
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University Hospital of Patras, Department of Respiratory Medicine
Pátrai, , Greece
Countries
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Other Identifiers
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ATTKPATRASCOVID19
Identifier Type: -
Identifier Source: org_study_id