Other Clinical Trial - Epidemiologic, Clinical, Molecular Characteristics

Status Recruiting

Clinical Trial 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 COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.

Clinical Trial Description

The analysis will include:

- study the expression levels of molecules known to mediated viral infection, like the Angiotensin converting enzyme 2 (ACE2) and genetic variants in these genes, which could be related to susceptibility to the viral infection and/or to the severity of the clinical course of the disease

- compare the frequency of genetic variants potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU

- germline DNA analysis to search for genetic factors predisposing or protecting against severe pulmonary affection in COVID-19 infected participants. To this aim DNA will be analyzed by a GWAS (Genome Wide Association Study) approach by using the GSA Illumina chip. 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 severe disease course

- explore the contribution of rare variants by studying the exome

- sepsis and ARDS biomarkers developed at ICH (e.g. PTX3, sIL-1R2, MSF) analysis to address their prognostic potential in Covid-19 patients

- PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome

- microbiota analysis of residual 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 for microbiota analysis ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04451577
Study type	Observational
Source	Istituto Clinico Humanitas
Contact	Maria Rescigno, PhD
Phone	00390282245431
Email	maria.rescigno@hunimed.eu
Status	Recruiting
Phase
Start date	June 1, 2020
Completion date	June 1, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection — UNICODE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms