Overview

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