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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.
The analysis will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention, analysis of biological samples |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Rescigno, PhD | Contact | 00390282245431 | maria.rescigno@hunimed.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas reseach hospital (ICH) | Recruiting | Rozzano | Milan | 20089 | Italy |
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blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples