NL-OMON49946尚未招募3 期
A randomized, double blinded clinical trial of convalescent plasma compared to standard plasma for treatment of hospitalized non-IC patients with COVID-19 infections - COV-PLAS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 430
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 至 99（—）
入选标准
- •1. Maximal 3 days hospitalized patients at plasma infusion.
- •2. Age * 18 years and * 85 years
- •3. SARS-CoV-2 infection: confirmed by PCR (BAL, sputum, nasal and/or pharyngeal
- •4. Symptoms not expected to lead to IC transfer within 6 hours of first plasma
- •administration
- •5. Written informed consent including storing of specimen for future testing
排除标准
- •1. Accompanying diseases other than COVID-19 with an expected survival time of
- •less than 12 months
- •2. Chronic obstructive lung disease (COPD), stage 4
- •3. Lung fibrosis with UIP pattern in CT und Severe emphysema
- •4. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left
- •ventricular ejection fraction to * 30%
- •5. Cardiovascular failure requiring diuretics
- •6. Signs of severe coagulopathy : thrombocytopenia a/o prolongation of the
- •PT/INR, PTT a/o elevation of D-dimer, a/o decreased fibrinogen level waardes ?
- •7. Liver cirrhosis Child C
- •8. Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one
- •9. Any history of severe adverse reactions to plasma proteins
- •10. Known deficiency of immunoglobulin A
- •11. Pregnancy
- •12. Breastfeeding women
- •13. Volume overload until sufficiently treated
- •14. Pulmonary edema
- •15. Participation in another clinical trial for treatment of COVID-19
- •16. Psychiatric or cognitive illness or recreational drug/alcohol use that in
- •the opinion of the principal investigator, would affect subject safety and/or
研究者
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