Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Sponsor
University Hospital of Patras (Other)
Overall Status
Recruiting
CT.gov ID
NCT05082714
Collaborator
(none)
251
1
2
6.4
39.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
251 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Non-inferiority trialNon-inferiority trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tocilizumab Versus Baricitinib in Hospitalized Patients With Severe COVID-19: an Open-label, Randomized Controlled Trial
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: tocilizumab

tocilizumab plus usual care

Drug: Tocilizumab
tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)

Experimental: baricitinib

baricitinib plus usual care

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. Mechanical ventilation or death by day 28 [day 28]

Secondary Outcome Measures

  1. Time to discharge over the 28-day period [day 28]

  2. World Health Organization scale at day 10 [range from 0 (not infected) to 10 (dead)] [day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Patras, Department of Respiratory Medicine Patras Greece

Sponsors and Collaborators

  • University Hospital of Patras

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Argyris Tzouvelekis, Associate Professor of Respiratory Medicine, Head Department of Respiratory Medicine, University Hospital of Patras
ClinicalTrials.gov Identifier:
NCT05082714
Other Study ID Numbers:
  • ATTKPATRASCOVID19
First Posted:
Oct 19, 2021
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Argyris Tzouvelekis, Associate Professor of Respiratory Medicine, Head Department of Respiratory Medicine, University Hospital of Patras
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022