Epidemiologic Clinical Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection
-
- STATUS
- Recruiting
-
- participants needed
- 5000
-
- sponsor
- Istituto Clinico Humanitas
Summary
The study cohort will be enrolled among all Humanitas group employees (including ICH,
Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked
consent for the research use of blood, pharyngeal swab, and for those hospitalized for
Description
The analysis will include:
- study the expression levels of molecules known to
mediated viralinfection , like theAngiotensin converting enzyme 2 (ACE2) andgenetic variants in these genes, which could be related to susceptibility to the viralinfection and/or to the severity of the clinical course of the disease - compare the frequency of
genetic variants potentially related withCOVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for thevirus but asymptomatic to individuals affected byCOVID-19 withARDS requiring admission to ICU - germline
DNA analysis to search forgenetic factors predisposing or protecting against severe pulmonary affection inCOVID-19 infected participants. To this aim DNA will be analyzed by a GWAS (Genome Wide Association Study) approach by using the GSA Illuminachip . The obtained data will also be used to try to develop a polygenic risk score to stratify individuals with a particularly high or low risk for severedisease course - explore the contribution of rare variants by studying the exome
sepsis andARDS biomarkers developed at ICH (e.g. PTX3, sIL-1R2, MSF) analysis to address their prognostic potential inCovid-19 patients- PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome
microbiota analysis ofresidual BAL and pharyngeal swab to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection- plasma and saliva/sputum
test for anti-SARS-Cov-2 antibodies (IgM, IgG, IgE and IgA) and formicrobiota analysis
Details
Condition | COVID |
---|---|
Age | 18years - 100years |
Treatment | No intervention |
Clinical Study Identifier | NCT04451577 |
Sponsor | Istituto Clinico Humanitas |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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