IRCT20150303021315N19招募中2 期
The evaluation of safety and efficacy of Pembrolizumab (CinnaGen Co, Iran) in patients with COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 70 years（—）
- 性别
- All
入选标准
- •Male or female patients aged 18 – 75 years while signing ICF
- •Able and willing to sign the informed consent
- •Patient with confirmed diagnosis of 2019-ncov infection based on RT-PCR and/or radiographic results
- •Clinical manifestation of:1- SpO2= 93% while resting and 2- Bilateral pulmonary involvement in radiographic results and 3- IL-6 < 7 pg/mL and 4- CRP < 50 mg/L and 5- Lymphocyte count > 800 cells/µL and 6- Ferritin < 300 µg/L
- •Adequate organ and marrow function
排除标准
- •Critical patients defined as: 1- respiratory failure which requiring mechanical ventilation or 2- Shock or 3- combined with other organ failure, need to be admitted to ICU
- •Patients with hepatitis B or C, HIV or active tuberculosis
- •Patient with COPD or end-stage lung disease requires home oxygen therapy
- •Patients with interstitial lung disease (ILD)
- •The underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor)
- •Active hepatic disease and hepatic failure
- •Active or history of autoimmune disease
- •Patients with myocarditis
- •History of organ, bone marrow or hematopoietic Stem Cell transplantation
- •Received radiotherapy and chemotherapy for malignant tumor within 6 months
- •Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain a live virus are permitted
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
- •Is receiving systemic steroid therapy < 3 days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication
- •Major surgery within 3 weeks before randomization
- •Hypersensivity to pembrolizumab, standard of care or any components of the formulation
- •90 days of retinal detachment or eye surgery
- •Permanent blindness in one eye, history of iritis, endophthalmitis, scleral inflammation or retinitis
- •Participated in other clinical intervention trials within the last 3 months
- •Pregnancy and breastfeeding
- •The competent physician considered it inappropriate to participate in the study
研究者
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