Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19

University Hospitals (UH)

Status and phase: Unknown; Phase 3

Conditions: Immuno-Deficiency; Covid19; Old Age; Debility

Treatments: Drug: SARS-CoV-2 convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04836260

2020-02989

Details and patient eligibility

About

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

Full 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 will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4).

Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)