Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
研究概览
简要总结
Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.
详细描述
This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.
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 (Investigator)
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
- •Over 18 years old
- •Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
- •Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock
- •The patient, or his representative, must sign an informed consent
排除标准
- •Participate in another clinical trial for CoViD- 19
- •History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),
- •History of allergic reaction due to IgA deficiency
- •Allergic reaction to sodium citrate or riboflavin (vitamin B2)
- •History of immunosuppression
研究组 & 干预措施
Convalescent plasma+Support treatment selected by the hospital
Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol.
干预措施: Inactivated convalescent plasma (Drug)
Convalescent plasma+Support treatment selected by the hospital
Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol.
干预措施: Support treatment (Drug)
Support treatment selected by the hospital
The best support treatment selected by the hospital, according to each institutional protocol. Due to the ongoing development of knowledge of pathophysiology and scientific evidence of the available alternatives, it will be selected at the time of treatment.
干预措施: Support treatment (Drug)
结局指标
主要结局
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
时间窗: Over a period of 28 days
To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital
次要结局
- Change in serum creatinine level(3, 7, 14 and 28 days)
- Change in aspartate aminotransferase level(3, 7, 14 and 28 days)
- Radiography imaging(Over a period of 60 days)
- Antibody titer(Day 0, Day 3 and Day 7)
- Clinical evolution(Over a period of 28 days)
- Change in lactate dehydrogenase level(3, 7, 14 and 28 days)
- Viral Load(0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first)
- Change in blood cell count(3, 7, 14 and 28 days)
- Change in bilirubin level(3, 7, 14 and 28 days)
- Change in creatine kinase MB level(3, 7, 14 and 28 days)
- Change in C reactive protein concentration(3, 7, 14 and 28 days)
- Oxygen-free days through Day 60(Until hospital discharge or a maximum of 60 days whichever comes first)
- Mechanical ventilation-free days through Day 28(Until hospital discharge or a maximum of 28 days whichever comes first)
- Clinical evolution by seven-parameter ordinal scale(3, 7, 14 and 28 days)
- Multi-organ failure progression(3, 7, 14 and 28 days)
- Change in alanin aminotransferase level(3, 7, 14 and 28 days)
- Change in Procalcitonin concentration(3, 7, 14 and 28 days)
- Change in IL6 level(3, 7, 14 and 28 days)
- Assessment of oxygenation(3, 7, 14 and 28 days)
- Intensive Care Unit (ICU)-free days through Day 28(Until hospital discharge or a maximum of 28 days whichever comes first)
- Tomography imaging(Over a period of 60 days)
- Change in hemoglobin concentration(3, 7, 14 and 28 days)
- Change in creatine kinase level(3, 7, 14 and 28 days)
- Change in D Dimer concentration(3, 7, 14 and 28 days)
- Hospital-free days through Day 60(Until hospital discharge or a maximum of 60 days whichever comes first)