Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- SAEs within 24 hours of plasma infusion
研究概览
简要总结
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.
详细描述
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.
Following patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory confirmed diagnosis of infection with SARS-CoV-2
- •Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
- •Symptoms less than 14 days
- •ID Physician determination that the patient does not need hospitalization
- •O2 saturation of >93%
- •Informed consent provided by the patient or healthcare proxy
- •Age ≥ 18 years
- •Ambulatory Outpatient when informed consent obtained and study drug is administered
排除标准
- •Age < 18 y/o
- •Patients currently receiving intravenous immunoglobulin
- •Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.
- •Need to be hospitalized
- •O2 sat < 93%
- •D-Dimer > 2x normal
- •Chronic oxygen therapy
- •Renal insufficiency with Creatinine clearance < 30
- •Long term care or assisted living facility resident
- •Ongoing usage of hydroxychloroquine for any indication
- •History of blood or plasma transfusion related complications
- •Enrollment into any other investigational drug or device study within the previous 30 days
- •Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up
- •Pregnant or breast feeding
- •Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety
- •Admitted to or expected to be admitted to a medical facility
结局指标
主要结局
SAEs within 24 hours of plasma infusion
时间窗: 28 days
Time to Resolution of Symptoms
时间窗: 28 days
a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted.
次要结局
- Hospitalization within 28 days(28 days)
- Decrease in Inflammatory Markers(28 days)