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Covid-IC: Covid-19 Convalescent Plasma and Monoclonal Antibodies Treatment of Immunocompromised Patients

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05905380
Collaborator
(none)
200
Enrollment
1
Location
11
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Data on the use of convalescent plasma in the treatment of covid-19 are scarce: the results of randomized studies involving mainly immunocompetent patients are disappointing, while case series or retrospective data on more selected patients , in particular immunocompromised patients suggest a benefit in these patients whose clinical manifestation seems essentially related to the uncontrolled infection and not the cytokine storm.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Analysis of the Efficacy and Tolerance of Covid-19 Convalescent Plasma and Monoclonal Antibodies in the Treatment of SARS-Cov2 Infections in Immunocompromised Patients
    Actual Study Start Date :
    Mar 2, 2023
    Anticipated Primary Completion Date :
    Jan 31, 2024
    Anticipated Study Completion Date :
    Jan 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective analysis of the tolerance of Covid-19 convalescent plasma and monoclonal antibodies in the treatment of SARS-Cov2 infections in immunocompromised patients [Files analysed retrospectively from February 25, 2020 to January 15, 2023 will be examined]

      This is a retrospective study on patient data from medical records from February 25, 2020 to January 15, 2023

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:

    • Adult patient

    • Immunocompromised patient (solid neoplasia, malignant hemopathy, solid organ transplantation, primary immune deficiency, systemic disease, chronic inflammatory disease, etc.)

    • Hospitalized between 25/02/2020 and 15/01/2023 at HUS, ICANS, CH Colmar and CH Mulhouse

    • Having received curative monoclonal antibody treatment or convalescent plasma treatment for SARS-Cov2 infection

    • Patient who has not expressed, after being informed, his opposition to the reuse of his data for scientific research purposes.

    Exclusion criteria:

    • Subject who expressed their opposition to participating in the study

    • Subject under guardianship, curatorship or safeguard of justice

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05905380
    Other Study ID Numbers:
    • 8784
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Covid-19
    SARS-Cov2
    Immunosuppression
    Cytokine
    Convalescent Plasma
    Monoclonal
    Antibodies
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 18, 2023