Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Baricitinib: 4 mg OD for up to 14 days
Control Intervention1: Standard of care: with or without remdesivir, dexamethasone
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 18 years and above of either sex Hospital admission within 10 days of RT-PCR positivity for COVID-19 SpO2 venturi mask or non-rebreather mask Normal procalcitonin- 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
Exclusion criteria
Exclusion criteria: 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of death or respiratory failureTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical status as assessed on NIAID 8-point ordinal scale compared to baselineTimepoint: Day 28;Duration of hospitalizationTimepoint: Day 180;Duration of ICU daysTimepoint: Day 180;Duration of invasive ventilationTimepoint: Day 180;Duration of noninvasive ventilationTimepoint: Day 180;Duration of oxygen therapyTimepoint: Day 180;Incidence of laboratory confirmed secondary bacterial infectionsTimepoint: Day 28;Incidence of laboratory confirmed secondary fungal infectionsTimepoint: Day 28 and Day 180;Incidence of thrombotic eventsTimepoint: Day 28;Percentage of Participants with a Change in Oxygen Saturation from 94% to â?¥94% from BaselineTimepoint: Day 28;Proportion of deathTimepoint: Day 14 and Day 28;Proportion of participants who require invasive ventilationTimepoint: Day 14 and Day 28;Proportion of participants who require noninvasive ventilationTimepoint: Day 14 and Day 28;Proportion of participants who require oxygenTimepoint: Day 14 and Day 28;Proportion of participants with adverse events of special interest in each treatment armTimepoint: Day 14, Day 28 and Day 180;Proportion of respiratory failureTimepoint: Day 14 and Day 28;Time to clinical improvementTimepoint: Day 180;Time to SpO2 94% on room airTimepoint: Day 180 | — |
Countries
India
Contacts
Public ContactNanda Gamad
PGIMER, Chandigarh
Outcome results
None listed