Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

COVID-19 Clinical Trial

Official title:

Tocilizumab Versus Baricitinib in Hospitalized Patients With Severe COVID-19: an Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082714
• Other study ID #: ATTKPATRASCOVID19
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: June 4, 2022

Study information

• Verified date: November 2023
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: June 4, 2022
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Greece	University Hospital of Patras, Department of Respiratory Medicine	Patras

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation or death by day 28		day 28
Secondary	Time to discharge over the 28-day period		day 28
Secondary	World Health Organization scale at day 10 [range from 0 (not infected) to 10 (dead)]		day 10