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CoV-ETH: Spread and Course of COVID-19 Infections

Sponsor
Goldhahn Jörg (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04377724
Collaborator
(none)
3,000
Enrollment
1
Location
22.1
Anticipated Duration (Months)
135.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Serological Study on the Spread and Course of COVID-19 Infections
    Actual Study Start Date :
    Apr 27, 2020
    Anticipated Primary Completion Date :
    Feb 28, 2022
    Anticipated Study Completion Date :
    Feb 28, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    ETH cohort

    employees or students at ETH Zurich, Switzerland

    Outcome Measures

    Primary Outcome Measures

    1. seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens [12 months]

    Secondary Outcome Measures

    1. the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens [12 months]

    2. the property of IgM and IgA antibody titers against the nucleocapsid protein of SARS-CoV-2 in symptomatic as well as asymptomatic COVID-19 infections over the course of time following an infection [12 months]

    3. the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ETH employee or ETH student and their family members living in the same household at the start of the study

    • Between 18 and 64 years of age at the start of the study

    • Signed informed consent

    Exclusion Criteria:

    • Age over 64 years at the start of the study

    • In quarantine or self-confinement at the start of the study

    • Active COVID-19 infection at the start of the study:

    • Diagnosed with a laboratory test

    • Suspected based on typical symptoms such as fever (>38°C), acute pulmonary ex-acerbation or sudden loss of gustatory taste

    • The following medical condition

    • With continuous steroid therapy/ chemotherapy/immunsuppressive therapy

    • In treatment for cancer

    • With severe autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ETH Zürich Switzerland 8092

    Sponsors and Collaborators

    • Goldhahn Jörg

    Investigators

    • Study Chair: Jörg Goldhahn, MD, ETH Zurich
    • Study Director: Susanne Ulbrich, Prof. Dr., ETH Zurich
    • Study Director: Markus Stoffel, Prof. Dr., ETH Zurich

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Goldhahn Jörg, Deputy director of the Institute for Translational Medicine, ETH Zurich
    ClinicalTrials.gov Identifier:
    NCT04377724
    Other Study ID Numbers:
    • 20-05
    First Posted:
    May 6, 2020
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 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:
    COVID-19
    Virus Diseases

    Study Results

    No Results Posted as of Aug 31, 2021