CTRI/2021/11/037866尚未招募未知
A multicenter, randomized, controlled, parallel-design trial evaluating Baricitinib in hospitalized patients with COVID19 pneumonia (COVID-BAR trial) - COVID-BAR
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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