Status:
UNKNOWN
Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Ospedale Regionale di Lugano
Conditions:
Covid19
Immuno-Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 decrea...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04836260
Start Date
April 8 2021
End Date
December 31 2021
Last Update
April 8 2021
Active Locations (4)
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1
Universitätsspital Basel
Basel, Switzerland, 4031
2
HFR-Fribourg Hôpital Cantonal
Fribourg, Switzerland, 1708
3
Geneva University Hospitals
Geneva, Switzerland, 1205
4
Ospedale Regionale di Lugano
Lugano, Switzerland, 6900