COVID-19
Conditions
Keywords
COVID-19, Acute Respiratory Distress Syndrome, PaO2/FiO2, Tocilizumab, Baricitinib
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%.
Interventions
DRUGTocilizumab
tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)
DRUGBaricitinib
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
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mechanical ventilation or death by day 28 | day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Greece
Outcome results
None listed