Covid-19CoV-ETHNCT04377724
Spread and Course of COVID-19 Infections
An observational study of Covid-19 and Virus Disease, run by Goldhahn Jörg at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Virus Disease
- How many people
- 2,910 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Apr 2020to 4 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- With continuous steroid therapy/ chemotherapy/immunsuppressive therapy
- In treatment for cancer
- With severe autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Covid-19, Virus Disease
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ETH cohort | employees or students at ETH Zurich, Switzerland |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens
Measured: 12 months
Secondary outcomes (3)
the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens
Measured: 12 months
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
Measured: 12 months
the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start27 Apr 2020
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldhahn Jörg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goldhahn Jörg, ETH Zurich
- Investigators
- Jörg Goldhahn, MD, Study chair, ETH ZurichSusanne Ulbrich, Prof. Dr., Study director, ETH ZurichMarkus Stoffel, Prof. Dr., Study director, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377724
- Sponsor's protocol ID
- 20-05
- Acronym
- CoV-ETH
- Status last verified
- Feb 2023
- First submitted
- 5 May 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Serological Study on the Spread and Course of COVID-19 Infections
- ClinicalTrials.gov ID
- NCT04377724
- Acronym / sponsor ID
- CoV-ETH / 20-05
- Conditions
- Covid-19, Virus Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,910 participants (actual)
- Lead sponsor
- Goldhahn JörgUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETH cohort | – | –employees or students at ETH Zurich, Switzerland |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- The following medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens
Time frame: 12 months
3 secondary outcomes
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
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
the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Goldhahn, MD study chair
ETH Zurich
Susanne Ulbrich, Prof. Dr. study director
ETH Zurich
Markus Stoffel, Prof. Dr. study director
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Virus Disease, run by Goldhahn Jörg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.