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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Collaborators: Hôpital Fribourgeois; Ospedale Regionale di Lugano; University Hospital, Basel, Switzerland

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