Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Type of Respiratory Support
研究概览
简要总结
The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.
Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.
Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.
Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age greater or equal to 18
- •Able to donate blood per blood bank standard guidelines
- •Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
- •Complete resolution of symptoms at least 28 days prior to donation
- •Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors
排除标准
- •Does not provide consent
- •Does not meet standard blood bank donation guidelines
- •Unsuccessful blood donation
- •Recipient Inclusion Criteria:
- •Patients must be 18 years of age or older
- •Must have laboratory-confirmed COVID-19
- •Must have severe or immediately life-threatening COVID-19
- •Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
- •Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
- •Must be less than 21 days from the start of illness
- •Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
- •Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
- •Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma
- •Recipient Exclusion Criteria:
- •Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
- •Receipt of pooled immunoglobulin in past 30 days
- •Contraindication to transfusion or history of prior reactions to transfusion blood products
- •Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma
结局指标
主要结局
Type of Respiratory Support
时间窗: Until discharge from hospital
Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.
Success of Administering Plasma
时间窗: At time of administration
Number of patients who receive convalescent plasma
次要结局
- ICU Mortality(Until discharge)
- Hospital Length of Stay(Until discharge)
- Ventilator-free Days(28 days)
- Cardiac Arrest(28 days after plasma administration)
- Transfer to ICU(28 days)
- ICU Length of Stay(Up to 50 days)
- Hospital Mortality(Until discharge)
- Overall Survival (28-day Mortality)(28 days)