Passive Immunity Trial for Our Nation (PassItOn)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 974
- 试验地点
- 52
- 主要终点
- COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
详细描述
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 than or equal to 18 years
- •Currently hospitalized or in an emergency department with anticipated hospitalization
- •Symptoms of acute respiratory infection, defined as one or more of the following:
- •Chills, or a fever (greater than 37.5° C or 99.5° F)
- •Shortness of breath, operationalized as a patient having any of the following:
- •i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy
- •Laboratory-confirmed SARS-CoV-2 infection within the past 14 days
排除标准
- •Unable to randomize within 14 days after onset of acute respiratory infection symptoms
- •Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.)
- •Inability to be contacted on Day 29-36 for clinical outcome assessment
- •Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
- •Contraindications to transfusion or history of prior reactions to transfused blood products
- •Plan for hospital discharge within 24 hours of enrollment
- •Previous enrollment in this trial
- •Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
- •Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
- •Prior receipt of SARS-CoV-2 vaccine
结局指标
主要结局
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
时间窗: Study Day 15
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
次要结局
- Survival Through 28 Days(Baseline to Day 28 (assessed on Study Day 29))
- All-location, All-cause 14-day Mortality(Baseline to Study Day 14)
- All-location, All-cause 28-day Mortality(Baseline to Study Day 28)
- COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3(Baseline to Study Day 3)
- Hospital-free Days Through Day 28(Baseline to Day 28)
- COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29(Study Day 29)
- Oxygen-free Days Through Day 28(Baseline to Day 28)
- Ventilator-free Days Through Day 28(Baseline to Day 28)
- Vasopressor-free Days Through Day 28(Baseline to Day 28)
- ICU-free Days Through Day 28(Baseline to Day 28)
- COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8(Study Day 8)
研究者
Todd Rice
Associate Professor of Medicine
Vanderbilt University Medical Center