- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04377724
Spread and Course of COVID-19 Infections (CoV-ETH)
February 22, 2023 updated by: Goldhahn Jörg
Longitudinal Serological Study on the Spread and Course of COVID-19 Infections
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2910
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zürich, Switzerland, 8092
- ETH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The cohort consists of initially healthy volunteers, all employees or students of ETH.
Inclusion into the longitudinal study will be carried out in strict response to the STOP safety concept of the Safety, Security, Health and Environment administrative department of ETH.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ETH cohort
employees or students at ETH Zurich, Switzerland
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens
Time Frame: 12 months
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12 months
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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
Time Frame: 12 months
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12 months
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the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jörg Goldhahn, MD, ETH Zurich
- Study Director: Susanne Ulbrich, Prof. Dr., ETH Zurich
- Study Director: Markus Stoffel, Prof. Dr., ETH Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2020
Primary Completion (Actual)
February 4, 2022
Study Completion (Actual)
February 4, 2022
Study Registration Dates
First Submitted
May 5, 2020
First Submitted That Met QC Criteria
May 5, 2020
First Posted (Actual)
May 6, 2020
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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