Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Side effects
研究概览
简要总结
Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.
详细描述
A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The research was blinded as possible for the result's evaluators and those responsible for the statistical analysis. All patients admitted to the investigation were placed with a marker indicating that they were a patient of the plasma protocol, but not mention the study group. The data collectors and the outcome adjudicators were unaware of the treatment assignments.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •O2 saturation <93%
- •Radiographic evidence of moderate pneumonia according to Rale's classification.
- •Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315)
- •Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)
排除标准
- •Pregnant patients
- •History of transfusion reactions
- •Patients with congestive heart failure
- •Patients with a history of chronic kidney failure on dialysis
- •Patients with multiple organ failure
- •Patients who does not accept or agree with the treatment.
结局指标
主要结局
Side effects
时间窗: Up to 30 days later from study entry
Side effects associated with the administration of convalescent plasma
Disease progression
时间窗: Up to 30 days later from study entry
Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization
Mortality
时间窗: Up to 30 days later from study entry
Any cause of death
次要结局
- Acute adverse events (AAE)(After receiving intervention, an average time one hour, until 24 hours after administration.)
- Respiratory improvement(10 days)
- Clinical improvement(10 days)