Intermediate IND Severe Illness COVID-19 CP
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure.
研究概览
简要总结
Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to 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 will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.
详细描述
Subjects will receive open-label screened plasma from COVID-19+ clinically resolved individuals (≥14 days post-resolution). Dosing of single or double plasma units (weight based < and > 90Kg) will be administered on days 0, 2, 4, 6, and 8 (based on plasma availability), or until futility (if either occurs before day 8) is determined by the ICU. Doses can be omitted at the discretion of the treating clinician (e.g., TRALI events are 100% donor-dependent and do not prohibit future transfusions).
The study drug is the investigational product, anti-SARS-CoV-2 convalescent plasma obtained from the American Red Cross or local plasma supply (medicDal center or city/region-wide shared blood bank) from patients identified as having recovered from COVID-19. Donors and samples will be screened for infections transmitted via transfusion (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T.cruzi, ZIKV) both through the use of the uniform donor questionnaire and FDA mandated blood donor screening tests. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols.
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
- •Laboratory confirmed COVID-19
- •Severe or Immediately life threatening COVID-19
- •Respiratory frequency > 30/minute
- •Blood oxygen saturation <93%
- •Life-threatening disease is defined as the following
- •Respiratory Failure.
- •Septic shock, and/or,
- •Multiple organ dysfunction or failure.
排除标准
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- •Other documented uncontrolled infection.
- •Severe DIC needing factor replacement, FFP, cryoprecipitate.
- •On dialysis.
- •Active intracranial bleeding.
- •Clinically significant myocardial ischemia.
研究组 & 干预措施
Treatment with Convalescent Plasma
SARS-CoV-2 convalescent plasma from approved donors will be transfused into severely ill patients with confirmed COVID-19 severe respiratory distress. Plasma will be administered on days 0, 2,4, 6 and 8.
干预措施: SARS-CoV-2 plasma (Drug)
结局指标
主要结局
Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure.
时间窗: Track patient progress for 28 days post initial convalescent dose.
Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma
次要结局
- Ventilatory free days(Track patient progress for 28 days post initial convalescent dose.)
- Patient mortality (including death from any cause)(Track patient progress for 28 days post initial convalescent dose.)