IMSEQ: COVID-19 Immune Repertoire Sequencing

Sponsor
Institute of Tropical Medicine, Belgium (Other)
Overall Status
Recruiting
CT.gov ID
NCT04368143
Collaborator
University Hospital, Antwerp (Other)
100
Enrollment
1
Location
33
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This concerns a single-center prospective interventional cohort study. Laboratory-confirmed COVID-19 patients will be asked to donate blood at at least two different timepoints. This will allow us to investigate T and B cell evolutions during the course of infection and recovery. The expected duration of the study is four months or the total duration of the SARS-CoV-2 circulation in Belgium (whichever is shortest).

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    COVID-19 Immune Repertoire Sequencing
    Actual Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions. [4 months]

    Secondary Outcome Measures

    1. study evolutions in B and T cell repertoires to understand COVID-19 specific immune responses fundamentally. [every 7 days during hospitalization a bloodsample is taken]

    2. clinical and epidemiological description of UZA hospitalized COVID-19 patients [at hospitalization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • laboratory confirmed COVID-19 acute infection

    • be older than 18 years of age

    • be hospitalized at the UZA

    • willing and able to provide written informed consent by the participant or its legal representative (for instance in case of medical incapacitation)

    Exclusion Criteria:
    • younger than 18 years old

    • Ambulatory patients

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Universitairy hospital of AntwerpAntwerpBelgium

    Sponsors and Collaborators

    • Institute of Tropical Medicine, Belgium
    • University Hospital, Antwerp

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Tropical Medicine, Belgium
    ClinicalTrials.gov Identifier:
    NCT04368143
    Other Study ID Numbers:
    • IMSEQ
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022