Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Drug: Tocilizumab; Drug: Baricitinib

• Registration Number: NCT05082714
• Lead Sponsor: University Hospital of Patras

Brief Summary

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

Detailed Description

Patients with COVID-19 will be assigned to one of the two arms on 1:1 ratio based on the time point that PaO2/FiO2\<200 will be observed. Patients aged 18 years or older with PaO2/FiO2 \<200 at any time during their hospitalization will be included in the analysis irrespective of values in inflammatory markers, such as CRP and ferritin. Exclusion criteria will be: age\<18 years, pregnancy, glomerular filtration rate\<30 and application of mechanical ventilation prior patients' transfer to our Hospital. Each patient or the patient's legally authorized representative provided written or witnessed oral informed consent.

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%.

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-19
• Study Start: 2021-10-20
• Primary Completion: 2022-06-04
• Study Completion: 2022-06-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• COVID-19, PaO2/FiO2<200

Exclusion Criteria

• Age<18 years, Pregnancy, Glomerular filtration rate<30, Application of mechanical ventilation prior patients' transfer to our Hospital

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tocilizumab	Tocilizumab	tocilizumab plus usual care
baricitinib	Baricitinib	baricitinib plus usual care

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation or death by day 28	day 28

Secondary Outcome Measures

Name	Time	Method
Time to discharge over the 28-day period	day 28
World Health Organization scale at day 10 [range from 0 (not infected) to 10 (dead)]	day 10

Trial Locations

Locations (1)

University Hospital of Patras, Department of Respiratory Medicine; 🇬🇷 Patras, Greece