EUCTR2020-001517-21-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients with COVID-19 Infection - COV-BARRIER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
- •PCR positive in sample collected <72 hours prior to randomization; OR
- •PCR positive in sample collected =72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •- Requires supplemental oxygen at the time of study entry and at randomization.
- •- Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 850
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 550
排除标准
- •- Are receiving cytotoxic or biologic treatments (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 at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
- •- Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
- •- Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for >=14 consecutive days in the month prior to study entry.
- •- Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
- •- Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-19.
- •- Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
- •- Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
- •- Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
- •- Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
- •- Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
- •- Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and /or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
- •- Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
- •- Have neutropenia (absolute neutrophil count <1000 cells/microliters)
- •- Have lymphopenia (absolute lymphocyte count <200 cells/microliters)
- •- Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN
- •- Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
- •- Have a known hypersensitivity to baricitinib or any of its excipients.
- •- Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Note: The participant should not be enrolled (start) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
- •- Are pregnant, or intend to become pregnant or breastfeed during the study.
- •- Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
- •- Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.
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