Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
详细描述
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).
Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows:
* Group of patients with critical illness:
Primary outcomes (Effectiveness and safety):
- Mortality
- Safety: Presence of adverse events
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
- Single (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
- •All patients
- •Patients diagnosed with COVID-19 infection by RT-PCR technique
- •Patients ≥ 18 years of age
- •Patients in standard care according to the national guide
- •Onset of symptoms ≤ 14 days
- •Signature of informed consent report
- •Patients at high risk of progression, defined by all of the following:
- •Score greater than 9 on the CALL scale
- •Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)
- •X-ray or CT compatible with pneumonia
- •Hospitalized patients
- •Critically ill patients, defined by any of the following:
- •Mechanical ventilation requeriment
- •Patients in Intensive Care Unit or Intermediate Care Unit
- •Ventilatory failure, septic shock, dysfunction or multi-organ failure
排除标准
- •Negative RT-PCR result from secretion 48 hours prior to study recruitment
- •History of allergic reaction to blood or plasma in patients with a known history of IgA deficiency
- •Patients participating in other clinical trial
- •History of allergy to blood products
- •History of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment
- •Pregnant women
结局指标
主要结局
Mortality
时间窗: Up to 30 days after the study enrollment
Death of the patient (yes/no)
Adverse events
时间窗: Up to 30 days after the study enrollment
Presence of any of the following adverse events (yes/no): 1. Nonhemolytic febrile reactions 2. Allergic reactions 3. Acute hemolytic reactions 4. Non-immune hemolysis 5. Acute transfusion-related lung damage 6. Transfusion-related circulatory overload 7. Metabolic reactions 8. Hypotensive reactions 9. Delayed hemolytic reactions 10. Post transfusion purple 11. Graft versus host disease 12. Bacterial contamination of blood components 13. Viral infections 14. Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)
ICU admission
时间窗: Up to 30 days after the study enrollment
Admitted to intensive care units (ICUs) (yes/no)
Mechanical ventilation
时间窗: Up to 30 days after the study enrollment
Mechanical ventilation requirement (yes/no)
次要结局
- Increase in lymphocyte count(Assessment at day 30 after study enrollment)
- LDH reduction(Assessment at day 30 after study enrollment)
- Decrease in Sequential Organ failure assessment (SOFA ) score(Assessment at day 30 after study enrollment)
- ICU length(Up to 30 days after the study enrollment)
- Reduction of Troponin level(Assessment at day 30 after study enrollment)
- Decrease in CRP(Assessment at day 30 after study enrollment)
- Reduction of D Dimer(Assessment at day 30 after study enrollment)
- Decrease in procalcitonin level(Assessment at day 30 after study enrollment)
- Decrease in ferritin level(Assessment at day 30 after study enrollment)
- Increase in PaO2 / Fio2(Assessment at day 30 after study enrollment)
- Extracorporeal membrane oxygenation (ECMO)(Assessment at day 30 after study enrollment)
- Lung infiltration(Assessment at day 30 after study enrollment)
研究者
Guillermo Enrique Quintero-Vega
Hematologist
Fundación Santa Fe de Bogota