Tocilizumab Versus Baricitinib in Hospitalized Patients With Severe COVID-19: an Open-label, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Mechanical ventilation or death by day 28
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
tocilizumab
tocilizumab plus usual care
Intervention: Tocilizumab (Drug)
baricitinib
baricitinib plus usual care
Intervention: Baricitinib (Drug)
Outcomes
Primary Outcomes
Mechanical ventilation or death by day 28
Time Frame: day 28
Secondary Outcomes
- 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)
Investigators
Argyris Tzouvelekis
Associate Professor of Respiratory Medicine, Head Department of Respiratory Medicine
University Hospital of Patras