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

Last updated: April 6, 2021
Sponsor: University Hospital, Geneva
Overall Status: Active - Recruiting

Phase

3

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT04836260
2020-02989
  • Ages > 18
  • All Genders

Study 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 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Immunocompromised patients defined as
  2. Solid organ transplant ≤1 year before inclusion or treated for acute or chronicrejection episode or
  3. Allogeneic stem cell transplant recipients ≤2 years before inclusion or treatedfor acute GvHD ≥grade 2 or chronic moderate-severe GvHD or
  4. Active solid or haematological oncological disease with curative perspectives or
  5. HIV infection with CD4<350 or
  6. Hypogammaglobulinemia and other severe genetic immunological defect or
  7. Auto-immune disease with biological immunosuppressive treatment* or
  8. 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)
  1. 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

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.

Connect with a study center

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • HFR-Fribourg Hôpital Cantonal

    Fribourg, 1708
    Switzerland

    Active - Recruiting

  • Geneva University Hospitals

    Geneva, 1205
    Switzerland

    Active - Recruiting

  • Ospedale Regionale di Lugano

    Lugano, 6900
    Switzerland

    Active - Recruiting

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