Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).
研究概览
简要总结
This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
详细描述
Following the administration of one unit (approximately 200 mL) of convalescent plasma over one hour, the study proposes to determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) by prevention of progression to severe or life threatening COVID-19 during the current hospitalization as determined by evaluating if the patient experienced the following the following: respiratory rate >30/min, Blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300, or received a medical diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure. This will be captured from the daily physical exam/clinical assessment done as part of routine care and at discharge.
The study also proposes to determine the immunologic effects of convalescent plasma infusion as measured by serial SARS-CoV-2 Ag levels through RT-PCR measured by CoV PCR collected at enrollment, day 7 and discharge.
Finally, the study intends to measure normalization of laboratory parameters for risk which will be documented every 3 days while the patient is hospitalized until the time that lab value returns to within the institution's normal range.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
- •Patients must also have the following indications for enrollment:
- •i. D-Dimer > 500 ng/ml FEU OR
- •ii. IL-6> 5 pg/mL
- •With any of the following:
- •iii. Lymphocytes < 0.8 103/ul OR
- •iv. LDH > 700 U/L OR
- •v. CK > 170 U/L OR
- •vi. CRP > 1.0 mg/dl OR
- •vii. Ferritin > 1000 ng/ml
- •AND one of the following:
- •viii. Age over 60 years
- •ix. Underlying Active Malignancy
- •x. Cardiovascular Disease
- •xi. Active Tobacco Use
- •xii. History of Pulmonary Volume Reduction Surgery
- •xiii. Hypertension
- •Prior Treatment: Patients are still eligible for this trial if active antimicrobial agents are in use. Patients are also eligible if they had been treated on COVID-19 clinical trial in the course of their disease.
- •Age ≥ 18 years.
- •The effects of allogeneic plasma infusion on the developing fetus is unknown. For this reason women who are pregnant are not eligible to participate.
- •Agrees to required laboratory data collected which will include the baseline organ function and regular ongoing assessments done as part of routine care.
- •Ability to understand and the willingness to sign a written informed consent document or ability to have consent provided by Legally Authorized Representative.
排除标准
- •4.2.1 Patients who do not meet above inclusion criteria are not eligible.
- •4.2.2 Patients may not be receiving any other investigational agents.
- •4.2.3 History of allergic reactions attributed to previous transfusion history.
- •4.2.4 Respiratory rate >30/min
- •4.2.5 Blood oxygen saturation <93%
- •4.2.6 Partial pressure of arterial oxygen to fraction of inspired oxygen ration <300
- •4.2.7 Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure
研究组 & 干预措施
Treatment Arm
Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.
干预措施: Convalescent Plasma (Biological)
结局指标
主要结局
Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).
时间窗: Through study completion, an average of 30 days
Measured by respiratory rate \>30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 and received a medical diagnosis of respiratory failure, septic shock or multiple
次要结局
- Determine the Immunologic Effects of Convalescent Plasma Infusion(Through study completion, an average of 14 days)
- Absolute Lymphocyte Count (10*3/uL)(Through study completion, an average of 14 days)
- Reatinine Kinase (mg/dL)(Through study completion, an average of 14 days)
- C-reactive Protein (mg/dl)(Through study completion, an average of 14 days)
- D-Dimer (ng/ml FEU)(Through study completion, an average of 14 days)
- Interleukin-6 (pg/ml)(Through study completion, an average of 14 days)
- Ferritin (ng/mL)(Through study completion, an average of 14 days)
研究者
Joseph M. Flynn, D.O., MPH
Principal Investigator
Norton Healthcare