NL-OMON49795招募中3 期
Convalescent Plasma Therapy from Recovered Patients to Treat COVID-19 Early in SARS-CoV-2 Disease - CoV-Early
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 690
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
- •PCR-confirmed COVID-19
- •Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoe, loss of
- •taste or smell, diarrhea, falls or confusion)
- •70 years or older OR 50-69 years and 1 or more of the risk factors described
- •1. A/ Medical history
- •Obesity with BMI 35 or higher
- •Born as a male person
- •History of cardiac or pulmonary disease (e.g. but not limited to atrial
- •fibrillation, coronary artery disease, heart failure, COPD, asthma)
- •History of neurological disease (e.g. a history of stroke or any other
- •chronic debilitating neurological disease)
- •Diabetes for which medical therapy is needed
- •Chronic kidney disease with GFR <60 ml/min
- •Reumatic disease (e.g. reumatoid arthritis, Systemic lupus erythematosus,
- •psoriatric artritis)
- •Immunodeficiency (e.g. organ or allogeneic transplantation, systemic
- •immunosuppressive drugs)
- •Cancer not in complete remission for >1 year (excluding baso -or
- •spinocellular skin cancers)
- •Untreated HIV and CD4 T-cells <200/microliter
- •Chronic liver disease, liver cirrhosis
- •1. B/ Lab results (if available)
- •CRP > 30
- •SARS-CoV-2 RT-PCR Ct value <25
排除标准
- •Life expectancy <28 days in the opinion of the treating physician
- •Patient or legal representative is unable to provide written informed consent
- •Symptomatic for 8 days or more
- •Being admitted to the hospital at the informed consent procedure
- •Known previous history of transfusion-related acute lung injury
- •Known IgA deficiency
研究者
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