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

Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection: a Retrospective-prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: COVID
• Intervention / Treatment: Other: No intervention

Detailed 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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Maria Rescigno, PhD; Phone Number: 00390282245431; Email: maria.rescigno@hunimed.eu

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Recruiting
      • Humanitas reseach hospital (ICH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts

Description

Inclusion Criteria:

• 1. Individuals aged ≥ 18 years;

Exclusion Criteria:

• 1. Lack of informed consent according to local procedure per critically ill patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EMPLOYEES WITHOUT COVID-19 INFECTION; Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Negativity to COVOD-19 will be tested by peripheral blood samples every month for 6 months (or until seroconversion). If they are positive for anti- covid 19 antibodies, a test for positivity of the virus will be carried out. T	Other: No intervention; No intervention, analysis of biological samples
EMPLOYEES WITH COVID-19 INFECTION; Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. employees that are Sars-Cov-2 positive both symptomatic and asymptomatic, there will be at least 2 peripheral blood samples (5 and 3 ml) at every control visit until ascertained negativity. They will also undergo a pharyngeal swab for viral titers and microbiota analysis at enrollment and at negativity. In addition, a sample of saliva/sputum will be collected for most of the employees at positivity and at every control visit. For employees hospitalized but not requiring intensive care the following samples will be collected: an aliquot of samples from the respiratory tract (e.g., bronchial aspirate, bronchoalveolar lavage) residual from the normal clinical practice; saliva/sputum; pharyngeal swab not used for diagnosis both at admission and at the first check up; blood sample in EDTA for plasma and peripheral blood mononuclear cell (PBMC)	Other: No intervention; No intervention, analysis of biological samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response to COVID-19	COVID-19 infection will be assessed by serological analysis of the presence of IgG anti-Covid-19 antibodies, an a subsequent pharyngeal swab. Symphtoms and possible hospitalization will be considered in clinical response.	36 months
Immunological response to COVID-19	PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).	36 months
Genetic predisposition to COVID-19	Genetic variants analysis 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	36 months
Microbiome-related response to COVID-19	Microbiota analysis (using 16S rDNA sequencing technology) of residual BAL, pharyngeal swab, plasma and saliva/sputum to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection	36 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (ACTUAL): June 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UNICODE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No