EUCTR2020-005486-14-PL进行中（未招募）1 期
sing of convalescent plasma in the treatment of COVID-19 patients with metabolomic and laboratory evaluation of the progress of plasma therapy - EPIC-19 (Efficacy of convalescent Plasma In Covid-19)
Wroclaw Medical University0 个研究点目标入组 500 人开始时间: 2020年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •FOR CLINICAL TRIAL PARTICIPANTS – THE DONORS:
- •Plasma donors will be recruited from two populations of COVID-19 recoveries: hospitalized and quarantined:
- •1.Age: from 18 to 65 (inclusive)
- •2.Body weight = 50 kg
- •3.Body temperature: Normal body temperature
- •4.Heart rate: 50 to 100 beats per minute
- •5.Arterial pressure: blood pressure values =180 mmHg for systolic pressure; =100 mmHg for diastolic pressure
- •6.Positive assessment of health condition based on a medical examination
- •7.Laboratory tests (obligatory for blood donors, before the procedure of collecting blood or its components): hemoglobin concentration or morphology, including the number of platelets, the number of white blood cells should remain within the laboratory norms according to the RCKiK SOP procedures
- •8.Plasma donors will be recruited after meeting the mandatory criteria - according to the RCKiK procedure described in Appendix no. 13 to the protocol
- •FOR CLINICAL TRIAL PARTICIPANTS – THE RECIPIENTS:
- •Patients hospitalized with a diagnosis of severe COVID-19 who meet the following criteria will be eligible for plasma transfusion:
- •1.Patients =18 years of age,
- •2.Patients hospitalized with a diagnosis of severe COVID-19,
- •3.Patients with SARS-CoV-2 infection confirmed by RT-PCR,
- •4.Patients who meet at least one of the criteria:
- •a.symptoms of respiratory failure with tachypnoea > 30 breaths / minute,
- •b.blood O2 saturation <94%,
- •c.O2 partial pressure (PaO2) = 80 mmHg,
- •d.MEWS severity score = 3 points.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •FOR CLINICAL TRIAL PARTICIPANTS – THE DONORS:
- •Volunteers with absolute contraindications or with temporary inability to donate blood will not be included in the clinical trial.
- •FOR CLINICAL TRIAL PARTICIPANTS – THE RECIPIENTS
- •1.Patients with a history of hypersensitivity to plasma, including anaphylactic shock in previous transfusions, allergic reactions to citrate, primary IgA deficiency,
- •2.Patients with symptoms of severe multi-organ failure,
- •3.Patients with known allergic reactions to chemical compounds used or generated in the procedure of pathogens inactivation,
- •4.Patients with active thrombosis.
研究者
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