Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04836260
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04836260
Study Brief:
Protocol Section:
NCT04836260