Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.
研究概览
简要总结
Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate pneumonia.
详细描述
Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2 that inhibits JAK1- and JAK2-mediated cytokine release, was recently described using BenevolentAI's proprietary artificial intelligence-derived knowledge graph, as an agent that reduces the endocytosis into target cells, and to inhibit the entry. Based on its potential action on inhibition of SARS-CoV-2 entry, and on its known effects on reduction of cytokine release, baricitinib therapy was proposed in patients with moderate pneumonia to explore: the safety of this drug combined with antiviral (lopinavir-ritonavir) in COVID-19; as second outcome, to evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters, and reduction of ICU admission.
Baricitinib was combined with antivirals because it does not interact with them due to its prevalent renal elimination.
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
- •SARS-Co-V2 positivitity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
- •Age >18 and <85 years
- •Presence of at least 3 of the following symptoms as present fever, cough, myalgia, fatigue.
- •Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography, or pulmonary ultrasound.
- •Peripheral capillary oxygen saturation (SpO2) > 92% on room air at screening
- •PaO2/FiO2 >100-300 mmHg at arterial blood gas analysis.
排除标准
- •Age < 18 and >85
- •History of thrombophlebitis
- •Latent tuberculosis infection (based on the positivity to QuantiFERON Plus positivity, Qiagen, Germany)
- •Pregnancy and lactation
- •History of malignancies over the previous 5 years, current diagnosis of malignancy
- •Inability or unwillingness to sign a written consent.
- •Transaminases values 4-fold higher than the upper normal limit.
- •HBV and HCV positivity.
- •Current Herpes zoster infection.
- •Evidence of concomitant bacterial infections.
研究组 & 干预措施
Case patients
Consecutive patients with COVID moderate pneumonia treated with baricitinib tablets 4 mg/day
干预措施: Baricitinib 4 MG Oral Tablet (Drug)
Controls
Consecutive patients with COVID moderate pneumonia treated with standard therapy before the date of the first baricitinib-treated patient.
干预措施: Baricitinib 4 MG Oral Tablet (Drug)
结局指标
主要结局
To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate.
时间窗: 2 weeks
All adverse event recording
次要结局
- To evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory parameters.(2 weeks)
- ICU admission rate(2 weeks)
- Discharge rate.(2 weeks)
研究者
Fabrizio Cantini
MD, Head of Rheumatology Department, Principal investigator
Hospital of Prato