Randomized, Double-blind, Placebo-controlled Clinical Trial of Convalescent Plasma for the Treatment of COVID-19 Pneumonia With Severity Criteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 2
- 主要终点
- Clinical status during follow-up at 30th day
研究概览
简要总结
A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation.
详细描述
Introduction
The use of convalescent plasma in the treatment of infectious diseases has been empirically performed for more than a century. It is based upon the assumption that providing exogenous neutralizing antibodies may provide protection while affected patients mount their own immune response. This therapeutic approach appears of particular interest in the context of the current pandemic, in which there is no specific vaccine available nor adequately proven effective pharmacological treatments.
Study purpose, hypothesis and general design
Purpose of the study: evaluate the effectiveness and safety of convalescent plasma in the treatment of SARS-CoV-2 pneumonia (Covid-19) Hypothesis: Convalescent plasma significantly improves the clinical outcome in patients with Covid-19 pneumonia and severity criteria.
Multicenter randomized, double-blind, placebo.controlled clinical trial. Placebo will be a saline solution.
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 pharmacist will be unblinded. The study intervention will be covered with an opaque development in order to ensure blinding of the intervention arm.
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
- •Confirmed diagnosis of Covid-19 through qualitative polymerase-reverse transcriptase (qRT-PCR -GeneDX Co, Ltd o similar).
- •Imagining-diagnosed pneumonia (Rx or CT scan).
- •MSOFA score (Modified SOFA) of 2 or more (modified organic failure assessment)
- •Informed consent.
排除标准
- •Pregnant women
- •Women at reproductive age not willing to avoid unprotected sexual intercourse up to Day 30 after study initiation.
- •Women in the breastfeeding period
- •Patients receiving experimental treatments under development within 30 days prior to study initiation.
- •Patients with a previous history of allergic reactions to blood or blood-components transfusion.
- •Diagnosis or clinical suspicion of an alternative microbiological cause for pneumonia besides COVID-19
- •Use of systemic corticosteroids within 15 days prior to entering the study.
结局指标
主要结局
Clinical status during follow-up at 30th day
时间窗: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
次要结局
- Time to death(In a 30 days follow up period)
- Clinical status during follow-up at 7th day(7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
- Time until discharge from ICU (days)(Whenever the patient is discharge from ICU or die in ICU, through study completion, an average of 10 days from admission)
- Time until hospital discharge (days).(Whenever the patient is discharge from the hospital or die without discharge, through study completion, an average of 14 days from admission)
- Plasma concentration of neutralizing antibodies at Day 7th(7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
- Time until complete functional recovery(Whenever the patient returns to basal functional status until 1 month from discharge)
- Percentage of patients with negative SARS-CoV-3 PCR at Day 14th(14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
- D Dimer plasma concentration at Day 14th(14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
- Ferritin plasma concentration at Day 13th(13th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
- Clinical status during follow-up at 14th day(14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
- Percentage of participants with adverse events / serious adverse events(In a 30 days follow up period)
- Post-transfusion adverse reactions(In a 30 days follow up period)
- Plasma concentration of neutralizing antibodies at Day 2nd(2nd Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))