Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
研究概览
简要总结
Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population.
The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication
详细描述
This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities.
Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4).
Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Immunocompromised patients defined as
- •Solid organ transplant ≤1 year before inclusion or treated for acute or chronic rejection episode or
- •Allogeneic stem cell transplant recipients ≤2 years before inclusion or treated for acute GvHD ≥grade 2 or chronic moderate-severe GvHD or
- •Active solid or haematological oncological disease with curative perspectives or
- •HIV infection with CD4<350 or
- •Hypogammaglobulinemia and other severe genetic immunological defect or
- •Auto-immune disease with biological immunosuppressive treatment* or
- •Other significant immunosuppressive condition such as IgG <6, treamtent with Rituximab or other biological lymphopenic treatment AND
- •Age ≥ 18 years old and
- •2 distinct ABO group determination and
- •Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 7 days and days post symptom onset (DPOS) ≤ 7 days at inclusion and/or
- •No oxygen requirement (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease, or O2 saturation ≥ 90% at room temperature and
- •Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
- •RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of infusion (highly suggested but not necessary)
- •Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition
- •Arterial hypertension under pharmacological treatment
- •Diabetes in treatment
- •Obesity (BMI ≥ 30 kg/m2)
- •Chronic obstructive pulmonary disease stade GOLD ≥2
- •Respiratory insufficiency due to any pneumopathy or neurologic disease.
- •Cardiovascular disease as defined by either known coronary heart disease, history of ischemic or hemorrhagic stroke or cardiac insufficiency (ejection fraction <40%)
- •Chronic kidney disease (GFR<60 ml/min) AND
- •2 distinct ABO group determination and
- •Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 3 days and days post symptom onset (DPOS) ≤ 3 days at inclusion or RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of perfusion and
- •No additional oxygen requirement compared to baseline (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease and
- •Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
- •Exclusion criteria:
- •Seroconversion at the time of inclusion
- •Palliative care
- •No signed informed consent
- •History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions
- •Disseminated intravascular coagulopathy (depending on specialist evaluation)
- •Uncontrolled acute hypervolemia
排除标准
- 未提供
结局指标
主要结局
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
时间窗: 14 days after plasma infusion
Proportion of death
时间窗: 28 days after plasma infusion
次要结局
- Proportion of patients with cleared nasopharyngeal viral load(14 days after plasma infusion)
研究者
Diem-Lan Vu
MD, PhD
University Hospital, Geneva