NCT04377724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,910

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

May 5, 2020

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens

    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

    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

    12 months

  • the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections

    12 months

Study Arms (1)

ETH cohort

employees or students at ETH Zurich, Switzerland

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH

Zurich, 8092, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CTG tubes

MeSH Terms

Conditions

COVID-19Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jörg Goldhahn, MD

    ETH Zurich

    STUDY CHAIR
  • Susanne Ulbrich, Prof. Dr.

    ETH Zurich

    STUDY DIRECTOR
  • Markus Stoffel, Prof. Dr.

    ETH Zurich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy director of the Institute for Translational Medicine

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 6, 2020

Study Start

April 27, 2020

Primary Completion

February 4, 2022

Study Completion

February 4, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations