Spread and Course of COVID-19 Infections | NCT04377724

Studies
Spread and Course of COVID-19 Infections

NCT04377724

Sponsor

Goldhahn Jörg

Status

Completed

Last Update Posted

Feb 23, 2023Actual

Enrollment

2,910Actual

Phase

Not provided

Conditions

Covid-19
Virus Disease

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2020Actual

Primary Completion Date

Feb 4, 2022Actual

Completion Date

Feb 4, 2022Actual

First Submitted Date

May 5, 2020

First Submission Date that Met QC Criteria

May 5, 2020

First Posted Date

May 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,910Actual

Label	Type	Description	Intervention Names
ETH cohort		employees or students at ETH Zurich, Switzerland

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens		12 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jörg Goldhahn, MD	ETH Zurich	Study Chair
Susanne Ulbrich, Prof. Dr.	ETH Zurich	Study Director
Markus Stoffel, Prof. Dr.	ETH Zurich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ETH		Zurich		8092	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D014777	Virus Diseases

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided