Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma Collected From Individuals With Documented Infection and Recovery From COVID-19 (SARS-CoV-2)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change is Clinical Status
研究概览
简要总结
The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
详细描述
The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with 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
- •Inclusion Criteria for Convalescent Plasma Donors:
- •Outpatients 18 years old and older who have recovered from COVID-19:
- •Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result
- •Complete resolution of symptoms at least 14 days prior to donation
- •Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit
- •Able to meet standard criteria for blood donation
- •Clinically stable based on provider assessment
排除标准
- •Exclusion criteria:
- •Inability to complete or contraindication to donation based on Donor History -
- •Questionnaire (DHQ), FDA approved standard blood donation form
- •Hb<13.0 g/dL for males
- •Hb<12.5 g/dL for females
- •History of 3 more pregnancies unless HLA antibody testing is performed and deemed acceptable by director of blood donor services (to reduce risks of transfusion Related Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases is based on history or test results from blood sample collected from the donor at time of plasma collection in accordance to standard practice.
- •Female subjects who are pregnant by self-report.
- •Receipt of pooled immunoglobulin in past 30 days
- •PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:
- •Patients in the Inova Health System with confirmed COVID-19 by PCR testing
- •Age ≥ 13 years
- •Currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome as follows:
- •Severe COVID-19: (three or more of the following)
- •Respiratory rate ≥ 30/min
- •Blood oxygen saturation (SpO2) ≤ 94% on room air
- •Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio < 300
- •Pulmonary infiltrates > 50% of lung parenchyma within 24 to 48 hours
- •Life-threatening disease is defined as: (one of the following)
- •Respiratory failure
- •Septic shock, and/or
- •Multiple organ dysfunction or failure
- •Patient must provide informed consent or have health care power of attorney/next of kin provide consent if he/she cannot.
- •PHASE 2 Exclusion Criteria:
- •Contraindication to receive plasma as deemed by the treating physician
- •Severe hypercoagulable state (documented in medical chart or by treating physician assessment)
- •Absolute IgA deficiency
- •Prior history of Transfusion Related Acute Lung Injury (TRALI)
- •Inability to tolerate plasma volume due to severe systolic or diastolic heart failure despite slower infusion and diuretic administration
- •Positive pregnancy test (HCG)
结局指标
主要结局
Change is Clinical Status
时间窗: Time of plasma infusion (day 0) compared to day 7
Change is clinical status as captured by 7-point ordinal scale to include 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized
Transfusion Related Events Due to Administration of CCP
时间窗: Within 6 hours of infusion
Number of participants with Transfusion Related Adverse Events
次要结局
- Mortality(From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.)
- Change is Clinical Status(Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28)
- Change in Mechanical Ventilation Status(Day 0 (date of CCP transfusion) to Day 28)
- Length of Hospital Stay(Total Index Hospitalization)
- Mechanical Ventilation(Days 7, 14, 21, 28)