Baricitinib Combined With Antiviral Therapy in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls.
研究概览
简要总结
There is no specific antiviral treatment recommended for COVID-19, and no vaccine is currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with excellent results in terms of clinical response and a good safety profile. Since baricitinib does not interact with antivirals due to its prevalent renal elimination, it may be used in combination.The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.
详细描述
Study design. Interventional, open-label, 2-week, prospective trial of a cohort of patients with mild to moderate COVID-19 infection.
Objectives. Primary. To assess the efficacy of baricitinib combined with antiviral therapy in patients with COVID-19-related mild and moderate disease in terms of reduction of the percentage of subjects requiring ICU admission.
Secondary objectives. To describe the clinical findings in a cohort of symptomatic COVID-19-infected subjects; to investigate the role of CRP, IL-6, and TNFα levels as predictor of progression to ARDS; to assess the type and incidence of adverse events (AEs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with mild to moderate COVID-19 infection
- •Age >18 years,
- •Clinical diagnosis of COVID19 infection
- •Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia.
- •All patients should be willing and able to provide written informed consent prior to performing study procedures.
排除标准
- •Age less than 18
- •History of thrombophlebitis.
- •Patient with latent tuberculosis infection (Quantiferon test).
- •Pregnancy and lactation.
研究组 & 干预措施
Patients
All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.
干预措施: Baricitinib (Drug)
Controls
All consecutive patients with mild to moderate COVID-19 infection, older than 18, a during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.
干预措施: Baricitinib (Drug)
结局指标
主要结局
The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls.
时间窗: 2 weeks
The percentage of ICU admission in patients and controls will be compared for statistical difference
次要结局
- The percentage of patients achieving the remission; CRP, IL-6 and TNFα values at baseline and during the treatment course; the number of AEs.(2 weeks)
研究者
Fabrizio Cantini
Head of Rheumatology Department, Principal investigator
Hospital of Prato