Trial NCT04421027
Publication COV-BARRIER - Ely EW, Lancet Respir Med (2022) (published paper)
Dates: 2020-12-23 to 2021-04-10
Funding: Private (Eli Lilly and Company)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / Argentina, Brazil, Mexico, USA
Follow-up duration (days): 60
Inclusion criteria
  • ≥18 years of age
  • hospitalized with laboratory-confirmed SARS-CoV-2 infection
  • use of IMV or ECMO at study entry and randomization
  • evidence of pneumonia or clinical symptoms of COVID-19
  • at least one elevated inflammatory marker above the upper limit of normal range based on the local laboratory result (C-reactive protein, D-dimer, lactate dehydrogenase, or ferritin).
Exclusion criteria
  • Receiving high dose corticosteroids (>20 mg per day [or prednisone equivalent] administered for >14 consecutive days in the month before study entry, unless indicated per SOC for a concurrent condition, such as asthma, chronic obstructive pulmonary disease, or adrenal insufficiency), immunosuppressants, biologics, T cell or B cell-targeted therapies, interferon, or JAK inhibitors
  • receipt of convalescent plasma or intravenous immunoglobulin for COVID-19
  • suspected serious active bacterial, fungal, or other infection, or untreated tuberculosis infection.
Interventions
Treatment
Baricitinib
4 mg by nasogastric tube or orally daily up to 14 days or until discharge. If eGFR = ≥30 to <60 mL/min/1·73 m2 at baseline or at any time during treatment, 2-mg daily until eGFR = ≥60 mL/min/1·73 m2.
Control
Placebo

Participants
Randomized
participants :
Placebo=50
Baricitinib=51
Characteristics of participants
N= 101
Mean age : NR
55 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=101
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
All-cause mortality by day 28 and day 60; number of ventilator-free days; overall improvement (assessed by odds of improvement in clinical status) on National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) evaluated at days 4, 7, 10, 14, and 28; proportion of participants with at least 1-point improvement on the NIAID-OS or live discharge from the hospital at days 4, 7, 10, 14, and 28; duration of hospitalisation; and time to recovery through day 28.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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
Low
General comment In addition to the published and pre-print article, the registry, addendum protocol, original trial protocol with statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The COV-BARRIER addendum trial in COVID-19 patients requiring invasive mechanical ventilation or ECMO was an extension of the original COV-BARRIER trial, in which eligible patients did not require either. For this reason, the inclusion and exclusion criteria do not wholly reflect those in the registry. Likewise, the outcomes reported do not reflect the primary outcome in the overall trial registry (need for IVM or ECMO or death), but do reflect the other registry outcomes. Safety outcomes reported were not in the registry but were in the original protocol. The study achieved its target sample size.
The study was updated on March 17th, 2022 with data from the published report.