CoVacSer

Overview
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The prospective CoVacSer cohort study examines SARS-CoV-2 immunity derived from serial blood samples as well as survey-based quality of life and ability to work in HCWs after COVID-19 vaccination and/or SARS-CoV-2 infection.

Sponsor: University Hospital Würzburg

SEEK ID: https://ldh.uk-wuerzburg.imise.uni-leipzig.de/projects/6

Public web page: Not specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 29th Sep 2021

Trial Project end date: 31st Dec 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : 29317

Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : CoVacSer - Längsschnittstudie zur Untersuchung der Immunantwort, Lebens- und Arbeitsqualität von Mitarbeiterinnen und Mitarbeitern im Gesundheitswesen nach COVID-19-Impfung und/oder -Infektion
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : CoVacSer
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : The prospective CoVacSer cohort study examines SARS-CoV-2 immunity derived from serial blood samples as well as survey-based quality of life and ability to work in healthcare workers (HCWs) after COVID-19 vaccination and/or SARS-CoV-2 infection.
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : Prospective cohort study, SARS-CoV-2, COVID-19 vaccination, Immunogenicity, Quality of Life, Work Ability Index, Healthcare Workers

Language(s) of the project : English

Web page of the project : https://www.pei.de/SharedDocs/awb/nis-0601-0700/0674.html

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitätsklinikum Würzburg
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Manuel
Family name(s)(*) : Krone
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Krone_M@ukw.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : Not specified
Identifier(*) : Not specified

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Unknown
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : COVID-19
Terminology/classification(*) : ICD-10
Code of the health condition or disease : U10.9
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the respiratory system (X)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing
Participants enrolled by invitation? : Yes
Start date : 29 September 2021
End date : 31 December 2024
Mono- or multicentric? : Not specified
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 99
Unit of age(*) : Years
Eligible gender : []
Inclusion criteria : Written informed consent, PCR-confirmed SARS-CoV-2 infection with first detection at least 14 days ago and/or at the earliest 14 days after SARS-CoV-2 vaccination dose, Working in healthcare sector at the time of SARS-CoV-2 infection, SARS-CoV-2 vaccination or at the time of recruitment
Exclusion criteria : - Missing or withdrawn informed consent; - Vaccination with a vaccine not authorized in the European Union
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Bavaria
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Usual risks of peripheral venous blood sampling
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Humoral and cellular immune response
Description of the outcome measure : Proportion of participants who show a humoral or cellular in vitro laboratory response at the respective study time points, which according to current information is associated with immunity to SARS-CoV-2
Type of the outcome measure : Primary
Time point(s) of assessment : 14-days, 3-month, 6-month, 12-month and 24-month after immunization event
Name of the outcome measure(*) : Quality of Life, Work Ability Index
Description of the outcome measure : Changes in downtimes, standardized scores of Quality of Life (WHOQOLBREF) and performance (WAI) due to SARS-CoV-2 vaccination or infection
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

CoVacSer

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