Baricitinib in hospitalized patients with COVID19 pneumonia: COVID-BAR Trial
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/11/037866
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
18 years and above of either sex
Hospital admission within 10 days of RT-PCR positivity for COVID-19
SpO2 <94% at room air and require low flow oxygen support- through nasal canula,
venturi mask or non-rebreather mask
Normal procalcitonin- <0.4 ng/mL with no other evidence of any co- or secondary
bacterial, viral or fungal infection at the time of randomization
Considered to be an appropriate participant for intervention with an immunomodulatory
in the opinion of the investigator
Should be able to be maintained on venous thromboembolism prophylaxis or current
maintenance therapy during inpatient dosing period, according to institutional protocol
Those who are on high flow oxygen or noninvasive or invasive mechanical ventilation or ECMO at the time of randomization
Those on steroids for more than 10 days for any indication
Patient has received baricitinib or any other immunomodulatory agent such as tumor
necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication within 4 weeks of the 1st dose of baricitinib
Patient has inability to supply direct informed consent or if it was not possible to obtain from Next of Kin or Independent Healthcare Provider on behalf of patient
Contraindications to study drugs, including history of hypersensitivity to the active substances or any of the excipients
Suspected or known active infections including but not limited to tuberculosis, hepatitis B or C (no blood screening required), herpes zoster or HIV.
Current or past (within 3 months) participation in any interventional clinical trial including COVID-19-related disease trials (observational studies allowed)
Patient moribund at presentation or screening or expected survival is <24h
Pregnant or lactating women at screening (or unwillingness to adhere to pregnancy
advice in protocol)
Either alanine transaminase or aspartate transaminase (ALT or AST) > 5 times the upper
limit of normal (ULN)
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated
creatinine clearance < 30 ml /min)
Currently receiving or ever received hyperimmune globulin, convalescent plasma or
intravenous immunoglobulin [IVIg]) for COVID-19
Patient has received neutralizing antibodies, such as bamlanivimab-etesevimab,
casirivimab-imdevimab and sotrovimab for COVID-19.
Patient has history of venous thromboembolism (VTE) (deep vein thrombosis [DVT]
and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or has a history
of recurrent ( >1) VTE
Current diagnosis of active malignancy that, in the opinion of the investigator, could
constitute a risk when taking investigational product
Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of death or respiratory failureTimepoint: Day 28
- Secondary Outcome Measures
Name Time Method