IRCT20200404046948N1招募中3 期
Randomized, parallel-controlled and multi-center clinical study evaluating the efficacy and safety of convalescent plasma, in the treatment of patients with severe SARS-CoV-2 infection (COVID-19)
Artesh University of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- •Laboratory confirmed COVID-19 by PCR
- •Aged 18 to 70 years old
- •Being inpatients
- •The clinical severe or immediately life-threatening COVID-19 (Severe patients meet any of the following: Dyspnea, Respiratory frequency = 30/min, Blood oxygen saturation = 93% (in resting state), partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)<300, and/or Lung infiltrates > 50% within 24 to 48 hours. Life-threatening disease is defined as: respiratory failure and need mechanical ventilation, septic shock, and/or multiple organ dysfunction or failure
- •The patient or his/her legal guardian will sign the informed consent and participate voluntarily
- •Accepting randomized allocation (allocating into any group)
- •Being hospitalized before the end of the clinical trial and available for any follow-up
排除标准
- •Those who has history of allergy to blood products or plasma components and auxiliary materials (sodium citrate)
- •Critical conditions like multiple organ failure, and the estimated survival time is less than 3 days
- •Severe congestive heart failure (CHF), or any other conditions in which plasma transfusion is contraindicated decided by researchers
- •Any risk factor which may increase the risk of thrombosis,
- •Pregnant or breastfeeding women
- •Participation in another clinical trial
- •Taking any other medicine for COVID 19 treatment out of the protocol
- •The doctor believes that the patient is not suitable to participate in this trial
研究者
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