Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Double-blind randomized controlled clinical trial (RCT) of low-dose lenalidomide in the treatment of elderly patients (> 60 years of age) with mild to moderate clinical signs of COVID-19 disease from the Hospital Universitario of Getafe.
The study will include patients of both sexes (> 60 years of age) with mild to moderate clinical presentation of COVID-19 (ROX index > 10). Subjects will be randomly assigned to the experimental arm with lenalidomide (5 mg/24h, day 1, 3 and 5) or to the controlled arm. Other concomitant medication for the treatment of COVID-19 will be also considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects > 60 years of age
- •Diagnosed case (PCR test for COVID-19 if available) or COVID-19 clinical symptoms (defined as fever, dry cough, dyspnea, chest radiography with compatible findings with COVID-19)
- •Lymphocyte count ≥ 0.2 x 103/µL and ≤1.0 x 103/µL.
- •Neutrophil count ≥ 1.8 x 103/µL, platelets ≥ 150 x 103/µL.
- •ROX ≥ 10 index
- •Signed informed consent document
- •Willing to comply with the lenalidomide Risk Minimization Program (Pregnancy Prevention Program approved)
排除标准
- •Absolute contraindication of lenalidomide use or hypersensitivity to the active ingredient or any of the excipients.
- •Active neoplasia
- •Previous autoimmune disease
- •Concurrent infection of HBV, HCV or tuberculosis.
- •Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal (ULN).
- •Bilirubin levels > 1.5 times the ULN
- •Renal impairment with an estimated GF < 30ml/min
- •Venous thromboembolism events within the previous 3 years
- •Significant active heart disease within the previous 6 months, including congestive heart failure (class II-IV NYHA), unstable angina or myocardial infarctions
- •Sexually active subjects who refuse the lenalidomide Risk Minimization Program
- •Inability to comply with the working protocol under the responsible health professional opinion.
研究组 & 干预措施
Experimental
Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
干预措施: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. (Drug)
Placebo
Patients will receive a placebo capsule PO daily, days 1, 3, and 5.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical improvement
时间窗: 30 days
Days to clinical recovery or days until discharge
Immune-inflammatory improvement
时间窗: 30 days
o Improvement of the neutrophil-to-lymphocyte ratio (NLR)
次要结局
- Mortality(30 days)