PACTR202006760881890招募中2 期
A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Clinical Trial of the Safety and Efficacy of Convalescent Plasma for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
agos State Government0 个研究点目标入组 100 人开始时间: 2020年6月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •A. Moderate to Severe COVID-19 disease cases
- •1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- •2. Understands and agrees to comply with planned study procedures.
- •3. Agrees to the collection of N-P, OP swabs, sputum and venous blood per protocol.
- •4. Male or non-pregnant female adult =18 years of age at time of enrolment.
- •5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen <7 days prior to randomization.
- •6. Illness of any duration, and at least one of the following: > 50% radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air OR requiring mechanical ventilation and/or supplemental oxygen.
- •7. If female of childbearing age, should agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site)
排除标准
- •1.ALT/AST > 5 times the upper limit of normal.
- •2.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
- •3.Pregnancy or breast feeding.
- •4.Anticipated transfer to another hospital which is not a study site within 72 hours.
- •5.Allergy to any study medication
研究者
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