COPID19: COVID-19 in PID Survey

Sponsor
Imagine Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04459689
Collaborator
(none)
200
1
24.5
8.2

Study Details

Study Description

Brief Summary

With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID).

Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19".

COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password.

Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey
    Actual Study Start Date :
    Mar 15, 2020
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Survival of patients with PID affected by COVID-19 [Baseline]

    2. Rate of admission to ICU of patients with PID affected by COVID-19 [Baseline]

    3. Rate of oxygen therapy of patients with PID affected by COVID-19 [Baseline]

    Secondary Outcome Measures

    1. Sequelae of patients with PID affected by COVID-19 [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Diagnosed with a Primary Immune Deficiency

    • COVID-19 (proven or probable)

    Exclusion Criteria:
    • Secondary Immune Deficiency

    • Other Coronovirus infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imagine Institute Paris France 75015

    Sponsors and Collaborators

    • Imagine Institute

    Investigators

    • Study Chair: Nizar MAHLAOUI, MD, MPH, PhD, Necker Enfants Malades University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Imagine Institute
    ClinicalTrials.gov Identifier:
    NCT04459689
    Other Study ID Numbers:
    • COPID19
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Sep 2, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Sep 2, 2021