A Randomized, Open-Label, Single Center Clinical Trial to Assess the Efficacy and Safety of Convalescent Plasma to Hospitalized Adult COVID-19 Patients as Adjunctive Therapy to Reduce the Need for ICU Admission: Co-CLARITY Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.
详细描述
This is a phase 3, randomized, non-placebo controlled, open-label, single-center clinical trial which will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma given from the 3rd to 14th day of illness after the onset of symptoms in preventing ICU admission among hospitalized COVID-19 patients compared to standard of care. Consecutive patients with COVID-19 admitted to the UP Philippine General Hospital will be offered participation into the study. Patients in the intervention group will receive one dose of type-specific anti-SARS-CoV-2 convalescent plasma (500 mL collected by whole blood donation or standard pheresis at the UP-PGH blood bank from a volunteer who recovered from COVID-19). The primary safety endpoints include serious adverse events judged to be related to convalescent plasma. The study also aims to compare anti-SARS-CoV-2 antibody titers and rates, levels, and duration of SARS-CoV-2 RNA in nasopharyngeal swabs using RT-PCR between the intervention and control groups.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 19 years of age or older
- •Hospitalized with COVID-19 and confirmed via SARS-CoV-2 RT-PCR testing
- •Patient is willing and able to provide written consent and comply with all protocol requirements
- •Patient agrees to storage of specimens for future testing
排除标准
- •Female subjects with positive pregnancy test, are breastfeeding or planning to become pregnant/breastfeed during the study period
- •Symptomatic illness exceeding 14 days from onset of illness at time of enrollment
- •ICU admission on initial presentation at the hospital (includes patients with clinical indications for ICU admission as follows:
- •Respiratory distress with requirement of O2 >6 lpm to maintain O2 sat >92%
- •Rapid escalation of O2 requirement/significant work of breathing
- •Hemodynamic instability: SBP <90, MAP <65
- •Receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (IVIg) in the past 30 days prior to enrolment
- •Known IgA deficiency
- •Presence of any contraindication to transfusion (or history of prior severe reactions to transfusion of blood products)
研究组 & 干预措施
Anti-SARS-CoV-2 convalescent plasma
About 500 mL of type-specific anti-SARS-CoV-2 convalescent plasma collected by whole blood donation or standard pheresis from a volunteer who recovered from COVID-19 transfused intravenously as 2 aliquots of 250 mL
干预措施: Anti-SARS-CoV-2 convalescent plasma (Drug)
结局指标
主要结局
Incidence of serious adverse events
时间窗: 28 days from enrollment
Cumulative incidence of serious adverse events (transfusion-related acute lung injury, transfusion associated circulatory overload, transfusion related infection and anaphylaxis/severe allergic reactions) during the study period
次要结局
- Quick SOFA (qSOFA) score(28 days from enrollment)
- Cardiopulmonary arrest(28 days from enrollment)
- Hospital length of stay(28 days from enrollment)
- ICU mortality(28 days from enrollment)
- ICU length of stay(28 days from enrollment)
- Hospital mortality(28 days from enrollment)
- Dialysis-free days(28 days from enrollment)
- Vasopressor-free days(28 days from enrollment)
- ICU-free days(28 days from enrollment)
- 28-day mortality(28 days from enrollment)
- Anti-SARS-CoV-2 antibody titers(days 0, 1, 7 and 14 of enrollment)
- SARS-CoV-2 RNA by RT-PCR(days 0, 1, 7 and 14 of enrollment)
研究者
Deonne Thaddeus Gauiran
Principal Investigator
University of the Philippines