preemptive use of convalescent plasma for high-risk patients with covid-19

Conditions: Covid19; Immuno-Deficiency; Old Age; Debility

Summary: 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

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.

Eligibility criteria:
inclusion criteria: 1. immunocompromised patients defined as 1. solid organ transplant ≤1 year before inclusion or treated for acute or chronic rejection episode or 2. allogeneic stem cell transplant recipients ≤2 years before inclusion or treated for acute gvhd ≥grade 2 or chronic moderate-severe gvhd or 3. active solid or haematological oncological disease with curative perspectives or 4. hiv infection with cd4\<350 or 5. hypogammaglobulinemia and other severe genetic immunological defect or 6. auto-immune disease with biological immunosuppressive treatment\* or 7. 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) 2. 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

Keywords: sars-cov-2 convalescent plasma