Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Need of invasive mechanical ventilation
研究概览
简要总结
No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2.
This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia.
Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio <150.
Secondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity.
Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.
Patients will be followed-up until 30 days from randomization.
详细描述
This is a multicenter prospective randomized open-label clinical trials. Patients with pneumonia due to SARS-CoV-2 will be included and randomized to receive or not convalescent plasma.
Convalescent plasma will be collected by cured patients with previous diagnosis of COVID-19. More specifically, inclusion and exclusion criteria for donors will be the following.
Inclusion criteria for donors:
- age > 18 and <60 years
- confirmed diagnosis of COVID-19: PCR on nasopharynx swab or positive IgG
- presence of 2 negative nasopharynx swabs for patients with previous positive swab and presence of 1 negative nasopharynx swab for patients with positive IgG
Exclusion criteria for donors:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Age > 18 years on day of signing informed consent
- •Informed written consent for participation in the study
- •Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- •Hospitalized due to clinical instrumental diagnosis of pneumonia
- •PaO2/FiO2 ratio 200-350
排除标准
- •mechanical ventilation (both invasive and non-invasive)
- •PaO2/FiO2<200
- •known hypersensitivity to immunoglobulin or blood components
结局指标
主要结局
Need of invasive mechanical ventilation
时间窗: 30 days
Need of invasive mechanical ventilation defined as PaO2/FiO2 \<150
次要结局
- Time to invasive mechanical ventilation(30 days)
- Length of hospital stay(30 days)
- Mortality rates(30 days)
- Adverse events(30 days)
- Time to virologic cure(30 days)
研究者
Francesco Menichetti
Professor
Azienda Ospedaliero, Universitaria Pisana