Trial NCT05082714
Publication Karampitsakos T, medRxiv (2022) (preprint)
Dates: 2021-10-18 to 2022-05-07
Funding: No specific funding (No funding)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Greece
Follow-up duration (days): 28
Inclusion criteria
  • Patients aged 18 years or older
  • presented with PaO2/FiO2 <200 at any time during their hospitalization
  • positive polymerase chain reaction test for SARS-CoV-2.
Exclusion criteria
  • Age<18 years
  • pregnancy
  • estimated glomerular filtration rate<30 mL/min/1.73m2
  • mechanical ventilation prior to patients’ transfer to our Hospital.
Interventions
Treatment
Baricitinib
4 mg orally once a day for up to 14 days or until discharge from hospital, whichever occurred first (or 2 mg/day in case of eGFR 30 to <60 mL/min/1.73m2)
Control
Tocilizumab
8 mg/kg intravenously single dose

Participants
Randomized
participants :
Baricitinib=125
Tocilizumab=126
Characteristics of participants
N= 251
Mean age : NR
148 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=251 Critical: n=0
Number of vaccinated participants: 49
Primary outcome
In the register
Mortality or mechanical ventilation by day 28
In the report
Mechanical ventilation or death by day 28
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the pre-print article, the prospective trial registry and dat gained from contact with authors were used in data extraction and assessment of risk of bias. There is no change from the trial registration in the intervention and control treatments. The primary and secondary outcomes in the article reflect those in the registry. Total adverse events are not reported. The trial (n = 251) achieved its target sample size (n = 251).
This study was updated on September 1, 2022 with data extracted after contact with authors.