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

April 6, 2021 updated by: Diem-Lan Vu, University Hospital, Geneva

Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial

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

Study Overview

Status

Recruiting

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Basel, Switzerland, 4031
        • Recruiting
        • Universitatsspital Basel
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Andreas Buser, MD
      • Fribourg, Switzerland, 1708
        • Recruiting
        • HFR-Fribourg Hôpital Cantonal
        • Contact:
        • Sub-Investigator:
          • Emmanuel Levrat, MD
      • Geneva, Switzerland, 1205
        • Recruiting
        • Geneva University Hospitals
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sophie Waldvogel-Abramowski, MD
      • Lugano, Switzerland, 6900
        • Recruiting
        • Ospedale Regionale di Lugano
        • Contact:
        • Sub-Investigator:
          • Stefano Fontana, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame: 7 days after plasma infusion
7 days after plasma infusion
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame: 14 days after plasma infusion
14 days after plasma infusion
Proportion of death
Time Frame: 28 days after plasma infusion
28 days after plasma infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with cleared nasopharyngeal viral load
Time Frame: 7 days after plasma infusion
Cleared viral load is defined as CT value ≥30
7 days after plasma infusion
Proportion of patients with cleared nasopharyngeal viral load
Time Frame: 14 days after plasma infusion
Cleared viral load is defined as CT value ≥30
14 days after plasma infusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time Frame: 21 days after plasma infusion
21 days after plasma infusion
Proportion of patients with cleared nasopharyngeal viral load
Time Frame: 21 days after plasma infusion
Will be evaluated if CT< 30 at 14 days
21 days after plasma infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laurent Kaiser, MD, University Hospital, Geneva
  • Principal Investigator: Enos Bernasconi, MD, Ospedale Regionale di Lugano
  • Principal Investigator: Véronique Erard, MD, HFR-Fribourg Hôpital Cantonal
  • Principal Investigator: Maja Weisser, MD, Klinik Infektiologie & Spitalhygiene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 8, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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