Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 29
- 主要终点
- Category Changes in the "7-Ordinal Scale"
研究概览
简要总结
A total of 278 patients are planned.
All patients will be in an early-stage of COVID-19. They must be adults and hospitalized.
In this study, all participating patients will receive the standard treatment provided according to the current treatment protocols for coronavirus disease. In addition to this treatment, each patient will be randomly assigned to receive additional treatment with convalescent plasma transfusion (CP; blood plasma from patients who have been cured of coronavirus), or continue with standard treatment but without adding transfusion.
50% of the chances of additional treatment with CP, and 50% of the chances of receiving only the standard treatment for coronavirus.
The duration of the study shall be one month from the assignment of the treatment.
The patient and the doctor will know the treatment assigned.
详细描述
A multi-center, randomized, clinical trial with two arms to study the efficacy and safety of passive immunotherapy with CP compared to a control of standard of care (SOC).
All trial participants will receive SOC:
- Treatment arm: Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors.
- Control arm: SOC for COVID-19.
Randomization among the two arms will be 1:1 and will be stratified per center. Of note, in the current status of a worldwide pandemic for which we have no approved vaccines or drugs, for the purpose of this trial SOC would also accept any drugs that are being used in clinical practice (e.g. lopinavir/ritonavir; darunavir/cobicistat; hydroxy/chloroquine, tocilizumab, etc.), other than those used as part of another clinical trial.
The study is planned with a sequential design. Interim analyses: comprehensive safety data monitoring analyses will be conducted when 20%, 40%, 60% and 80% of patients, or at the discretionary DSMB criteria when needed. A DSMB charter will be set before the trial initiation where criteria for prematurely stopping the trial due to safety issues will be set. Interim analyses will be predefined upfront based on the DSMB recommendations.
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
- 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
- •Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- •Male or female adult patient ≥18 years of age at time of enrolment.
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR in naso/oropharyngeal swabs or any other relevant specimen in the ongoing COVID-19 symptomatic period. Alternative test (i.e antigenic tests) are also acceptable as laboratory confirmation if their adequate specificity has been accepted by the sponsor.
- •Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive) or high flow oxygen devices and at least one of the following:
- •Radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- •Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air that requires supplemental oxygen.
- •No more than 7 days between the onset of symptoms (fever or cough) and treatment administration day.
排除标准
- •Requiring mechanical ventilation (invasive or non-invasive) or high flow oxygen devices.
- •More than 7 days since symptoms (fever or cough).
- •Participation in any other clinical trial of an experimental treatment for COVID-
- •In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •Any incompatibility or allergy to the administration of human plasma.
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
研究组 & 干预措施
Treatment Arm
Pathogen-reduced CP from patients recovered from COVID-19, whom, for the purpose of this trial, are herein designated as donors.
干预措施: Blood and derivatives. (Other)
Control Arm
Standard of Care (SOC) for COVID-19
干预措施: Standard of Care (Drug)
结局指标
主要结局
Category Changes in the "7-Ordinal Scale"
时间窗: 15 days
Proportion of patients in categories 5, 6 or 7 of the 7-point ordinal scale at day 15 7- Ordinal scale: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, on invasive mechanical ventilation or ECMO. 7. Death.
次要结局
- Status at day 30 in the "7-point ordinal scale"(30 days)
- Time to category 5, 6 or 7 of the " 7-Ordinal scale"(29 days)
- Time to an improvement of one category from admission in the "7-Ordinal scale"(29 days)
- Time to first deterioration(60 days)
- Mean change in the ranking in the "7-Ordinal scale" from baseline to days 3,5,8,11,15,29 and 60(60 days)
- Mean change in the ranking in the "11-Ordinal scale from baseline to days 3,5,8,11,15,29 and 60.(60 days)
- Status at day 15 and 30 in the "11-Ordinal scale"(30 days)
- Mortality of any cause at 15 days(15 days)
- Mortality of any cause at 28 days (day 29)(28 days (day 29))
- Mortality of any cause at 60 days(60 days)
- Oxygenation free days(29 days)
- Ventilator free days(29 days)
- Duration of hospitalization (days)(60 days)
- Incidence of thrombotic arterial events(60 days)
- Incidence of thrombotic venous events(60 days)
- Status at day 30 in the "11-Ordinal scale"(30 days)
- Infusion-related adverse events(60 days)
- Incidence of Treatment-Emergent Adverse Events(60 days)
- rate of rehospitalizations(60 days)
- Antibodies levels in CP donors recovered from COVID-19(3 months)
- Viral load(Days 1,3,5,8,11,15,29 and 60)
研究者
Cristina Avendaño Solá
MD, PhD
Puerta de Hierro University Hospital