Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19

Launched by UNIVERSITY HOSPITAL, GENEVA · Apr 6, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

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