Last updated: April 6, 2021
Sponsor: University Hospital, Geneva
Overall Status: Active - Recruiting
Phase
3
Condition
Hiv Infections
Treatment
N/AClinical Study ID
NCT04836260
2020-02989
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Immunocompromised patients defined as
- Solid organ transplant ≤1 year before inclusion or treated for acute or chronicrejection episode or
- Allogeneic stem cell transplant recipients ≤2 years before inclusion or treatedfor 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 withRituximab 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 anddays post symptom onset (DPOS) ≤ 7 days at inclusion and/or
- No oxygen requirement (WHO 8 ordinal scale < 4): asymptomatic, mild ormoderate disease, or O2 saturation ≥ 90% at room temperature and
- Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 orequivalent according to predefined antibody commercial assays cut-offs (seeStudy procedures)
- RT-PCR on a respiratory tract sample with CT value<20 or ascending kineticsat the time of infusion (highly suggested but not necessary)
- Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least oneco-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, historyof 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 dayspost symptom onset (DPOS) ≤ 3 days at inclusion or RT-PCR on a respiratory tractsample 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 equivalentaccording to predefined antibody commercial assays cut-offs (see Studyprocedures)
Exclusion
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 Swissmedicdefinitions
- Disseminated intravascular coagulopathy (depending on specialist evaluation)
- Uncontrolled acute hypervolemia
Study Design
Total Participants: 100
Study Start date:
April 08, 2021
Estimated Completion Date:
December 31, 2021
Study Description
Connect with a study center
Universitätsspital Basel
Basel, 4031
SwitzerlandActive - Recruiting
HFR-Fribourg Hôpital Cantonal
Fribourg, 1708
SwitzerlandActive - Recruiting
Geneva University Hospitals
Geneva, 1205
SwitzerlandActive - Recruiting
Ospedale Regionale di Lugano
Lugano, 6900
SwitzerlandActive - Recruiting
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