Randomized Controlled Trial of Tofacitinib versus Standard of Care Alone for COVID-19 Pneumonia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of subjects alive at day 14.
研究概览
简要总结
Rationale of the study –
Baricitinib, a JAK (Janus Kinase) inhibitorin combination with Remdesvir, was approved by the FDA in November, 2020 forCOVID-19. However, the cost and availability limits the use of Baricitinib inIndia. To overcome this, Tofacitinib, an inhibitor of JAK 1 and 3 has beentried. In a single-centre retrospective study, Tofacitinib plus dexamethasonewas compared with dexamethasone alone and a 70% reduction in odds of dying wasobserved in the combination group. This study aims to study the efficacy ofTofacitinib with standard of care versus standard of care alone in patientswith COVID-19 pneumonia.
Relevance and expected outcome:
Thesecond wave of COVID-19 has been devastating for India and mortality benefit ofan oral, accessible drug is an unmet need. We expect that initiation of immunomodulatory therapy with Tofacitinib will lead toimproved clinical outcome and reduce mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Adults of either sex with laboratory confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) ii.Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND hypoxia defined as room air saturation of <93% at admission.
排除标准
- •i.Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization ii.History of or known current thrombosis iii.Have a personal or first-degree family history of blood clotting disorders.
- •iv.Participants who are immunocompromised, with known immunodeficiencies v.Participants with any malignancy vi.Severe hepatic impairment, defined as Child-Pugh class C.
- •vii.Severe anemia (hemoglobin <8 g/dL).
- •viii.Absolute lymphocyte count <500 cells/mm; ix.Absolute neutrophil count <1000 cells/mm.
- •x.Known allergy to Tofacitinib.
- •xi.Other medical or psychiatric condition xii.Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) xiii.Have received any of these within 4 weeks prior to the first dose of study intervention: any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (e.g., Tocilizumab) or IL-1 inhibitors (e.g., anakinra) within the past 30 days; any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer.
- •xiv.Have received treatment with corticosteroids equivalent to prednisone or methylprednisolone >20 mg/day for equal or more than 14 consecutive days prior to screening.
- •xv.Current participation in other trials.
结局指标
主要结局
Proportion of subjects alive at day 14.
时间窗: Day 14
次要结局
- 1.Proportion of subjects on supplemental oxygen but not needing any form of mechanical ventilation, or ECMO by day 14.(2.Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.)