2020-02989

About this trial

Last updated 4 years ago

Study ID

2020-02989

Status

Unknown status

Type

Interventional

Phase

Phase 3

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 4 years ago

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

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)