COVIDOUT: Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04779346
Collaborator
(none)
500
1
24.3
20.6

Study Details

Study Description

Brief Summary

The COVIDOUT study will prospectively investigate the serological immunity of outpatient cancer patients to evaluate the prevalence of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and dependency of serological immunity on systemic (chemo)therapy after COVID19 disease as well as after vaccination.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this prospective observational study all cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) will be included in the study upon consent.

    Data will be collected as follows:

    (i) Serological antibody screening at study inclusion and every 3 months (ia) In case of vaccination monthly screening for 3 months (ii) Routine clinical data: demographic and biometric data, medical history, common laboratory parameters (iii) Patient questionnaire: assessment of past COVID-19 infection, past COVID-19 specific symptoms, social environment, vaccination

    Recruitment is limited to a one-year period (December 2020 - December 2021)

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting: Prevalence and Serological Immunity in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf
    Actual Study Start Date :
    Dec 21, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Outpatient cancer patients

    Cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE)

    Outcome Measures

    Primary Outcome Measures

    1. Rate of SARS-CoV-2 antibody positive patients [1 year]

      Measured in percentage

    2. Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 antibody positive patients [Up to 1 year]

      Measured in percentage

    3. Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients [Up to 1 year]

      Measured in percentage

    Secondary Outcome Measures

    1. Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients [1 year]

      Measured in percentage

    2. Rate of cancer entities in SARS-CoV-2 antibody positive patients [1 year]

      Measured in percentage

    3. Rate of therapy modalities in SARS-CoV-2 antibody positive patients [1 year]

      Measured in percentage

    4. Subgroup analysis of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients [Up to 1 year]

      Dependency of rate on cancer entity, therapy modality, age, sex and immune status [Measured in percentage]

    5. Rate of re-infection in SARS-CoV-2 antibody positive patients [1 year]

      Measured in percentage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Known diagnosis of cancer

    • Active disease or (in case of cure) last systemic therapy <12 months

    • Signed informed consent

    Exclusion Criteria:
    • Refusal of participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf

    Investigators

    • Principal Investigator: Marianne Sinn, MD, Universitätsklinikum Hamburg-Eppendorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT04779346
    Other Study ID Numbers:
    • 2020-10275-BO-ff
    First Posted:
    Mar 3, 2021
    Last Update Posted:
    Mar 22, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 Mar 22, 2021