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SEROCOV: Developement and Evaluation of Serological Assays for COVID-19

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04377763
Collaborator
(none)
500
Enrollment
1
Location
7.5
Anticipated Duration (Months)
66.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study aims to evaluate serological assays of virus Covid-19.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a retrospective monocentric study, which will include the patients who have hospitalized in Ambroise Paré Hospital and have sampling sent to the Laboratory of Microbiology of the hospital between the 15 March 2020 and 30 september 2020.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Developement and Evaluation of Serological Assays for COVID-19
    Actual Study Start Date :
    Jul 15, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2021
    Anticipated Study Completion Date :
    Mar 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Sensibility and specificity [Throughout of the study, an average of 6 months]

      Determination of sensibility and specificity of serological testing in SARS-CoV-2 virus in patients with acute respiratory symptoms.

    Secondary Outcome Measures

    1. Delay between the first symptoms and the positive serological result [Throughout of the study, an average of 6 months]

      Delay between the first symptoms and the positive serological result of SARS-CoV-2 virus.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient ≥ 18 years;

    • Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital;

    • Have diagnosed of a viral infection in respiratory.

    Exclusion Criteria:
    • Patient refusal.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP Boulogne-Billancourt France 92100

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Marie-Anne RAMEIX-WELTI, MD, PhD, Laboratoire de Microbiologie Hygiène hospitalière, Hôpital Ambroise paré, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04377763
    Other Study ID Numbers:
    • 20MWI-SEROCOV
    First Posted:
    May 6, 2020
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Feb 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
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    COVID-19
    serological assay
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Feb 25, 2021