A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma.
研究概览
简要总结
This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use.
Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.
The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.
详细描述
Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important that we evaluate this potential therapy in the context of clinical trials.
As such, this study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use.
This study will be opened across three separate site: Cedars-Sinai Medical Center, Johns Hopkins University, and University of Pittsburgh Medical Center. 30 patients will be recruited at each site. Each site has received its own FDA IND and IRB approval. As such, the following people are serving as sponsor-investigators at their respective institutions.
David Hager, MD PhD, Johns Hopkins University
Noah Merin, MD PhD, Cedars-Sinai Medical Center
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
- •18 years of age or older
- •Respiratory failure requiring mechanical ventilation due to COVID-19 induced pneumonia with confirmation via SARS-CoV-2 RT-PCR testing
- •PaO2/FiO2 ratio < 300 (or SpO2/FiO2 < 315)
- •Bilateral pulmonary infiltrates
排除标准
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- •In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours.
- •Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g.; stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.)
- •Use of home oxygen at baseline
- •Use of home mechanical ventilation at baseline (CPAP or BIPAP without need for oxygen is NOT an exclusion)
- •Respiratory failure caused by illness other than SARS-CoV-2
- •Other documented uncontrolled infection.
- •More than 72 hours have elapsed since first meeting inclusion criteria
- •Severe DIC, TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate.
- •Patient is on Warfarin and it is deemed necessary to maintain therapeutic INR (because the CP will reverse the warfarin effect).
- •On dialysis at the time enrollment is considered.
- •Active intracranial bleeding.
- •Clinically significant myocardial ischemia.
- •Prisoner or Incarceration
- •Pregnancy or active breast feeding
- •Has already received convalescent plasma for COVID-19 infection during current admission
- •Current participation in another interventional research study
- •Inability or unwillingness of subject or legal surrogate/representative to give written informed consent
结局指标
主要结局
Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma.
时间窗: 60 days
Feasibility of administering convalescent plasma to patients in the ICU who are intubated and mechanically ventilated due to COVID-19-induced respiratory failure will be assessed based on the proportion of subjects who consent and receive at least one dose of CP. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.
次要结局
- Overall survival of patients in the ICU receiving at least once dose of convalescent plasma for Covid-19-induced respiratory failure.(60 days)
研究者
Noah Merin
Assistant Professor
Cedars-Sinai Medical Center