Trial NCT04421027
Publication COV-BARRIER - Marconi V, Lancet Respir Med (2021) (published paper)
Dates: 2020-06-11 to 2021-01-15
Funding: Private (Eli Lilly and Company (Incyte Corporation licence))
Conflict of interest: Yes

Methods
RCT
Blinding: single blinding
Location : Multicenter / Argentina, Brazil, Germany, India, Italy, Japan, Mexico, Russia, South Korea, Spain, UK, USA (including Puerto Rico)
Follow-up duration (days): 60
Inclusion criteria
  • ≥18 years of age
  • hospitalized with laboratory confirmed SARS-CoV-2 infection
  • had evidence of pneumonia or active, symptomatic COVID-19
  • had ≥1 elevated inflammatory marker (C reactive protein, D-dimer, lactate dehydrogenase, ferritin)
  • participants requiring baseline oxygen support (later protocol amenendment implemented after enrollment had started)
Exclusion criteria
  • Requiring invasive mechanical ventilation (National Institute of Allergy and Infectious Disease Ordinal Scale [NIAID-OS] 7) at study entry
  • receiving immunosuppressants (high dose corticosteroids, biologics, T cell or B cell-targeted therapies, interferon, or JAK inhibitors)
  • received convalescent plasma or intravenous immunoglobulin for COVID-19
Interventions
Treatment
Baricitinib
4 mg orally once daily for 14 days or until discharge from hospital
Control
Placebo

Participants
Randomized
participants :
Placebo=761
Baricitinib=764
Characteristics of participants
N= 1525
Mean age : NR
963 males
Severity : Mild: n=186 / Moderate: n=962 / Severe: n=370 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO]) [ Time Frame: Day 1 to Day 28 ]
In the report
Proportion of participants who progressed to high-flow oxygen or non-invasive ventilation, invasive mechanical ventilation or extracorporeal membrane oxygenation, or death by day 28
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
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 published journal and pre-print articles, the prospective study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not accessed at the time of data extraction but they are available from the investigators upon request. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. The study reported on some secondary outcomes that were not listed in the registry, including adverse events and '≥2-point improvement on NIAID-OS or live discharge from hospital' (used for clinical improvement in our analysis). Some outcomes prespecified are not reported in the paper (e.g., Time to Definitive Extubation).
This trial was updated on September 28th, 2021 with data from the peer-reviewed journal publication. Mortality results were taken from the report and not the registry.