A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Mechanical Ventilation or Death Endpoint
研究概览
简要总结
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.
详细描述
A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study investigators analyzing the data and participants will be blinded to the randomization. It may not be feasible to blind nursing staff to the treatment assignment to ensure proper ABO checking of the plasma unit at bedside per standard transfusion procedures, but every effort will be made to preserve blinding of the investigators, participant, and primary team providing care. An unblinded research assistant who is not involved in other aspects of the study will randomize the participant once enrolled. Randomization will be provided to an unblinded provider who is not part of the care team who will place the order for the plasma (CCP vs. control plasma) using a paper order that will not be part of the electronic medical record. The safety monitoring committee (SMC) will review study data, including unblinded data, to evaluate the safety, efficacy, study progress, and conduct of the study.
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
- •for Enrollment:
- •Patients ≥18 years of age
- •Hospitalized with COVID-19
- •Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
- •Pulmonary infiltrates on chest imaging
- •Oxygenation of <95% on room air
- •Laboratory confirmed COVID-19
排除标准
- •Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
- •Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
- •Currently experiencing severe hypoxemic failure, as defined in study endpoints
- •Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
- •Not currently enrolled another interventional clinical trial of COVID-19 treatment.
- •Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19 treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication.
- •Note: Pregnancy is not exclusionary but will merit additional discussion of risks & benefits in the context of ongoing pregnancy
研究组 & 干预措施
COVID-19 Convalescent Plasma
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
干预措施: COVID-19 Convalescent Plasma (CCP) (Biological)
Placebo
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
干预措施: Placebo (Biological)
结局指标
主要结局
Mechanical Ventilation or Death Endpoint
时间窗: Day 14
Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.
次要结局
- Mechanical Ventilation or Death Endpoint(Day 28)
- 8-Point Ordinal Scale Endpoint(Day 29)
研究者
Priscilla Hsue, MD
Professor of Medicine
University of California, San Francisco