COVID
Conditions
Brief 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.
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
Interventions
OTHERNo intervention
No intervention, analysis of biological samples
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Individuals aged ≥ 18 years;
Exclusion criteria
* 1\. Lack of informed consent according to local procedure per critically ill patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to COVID-19 | 36 months | 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. |
| Immunological response to COVID-19 | 36 months | PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness). |
| Genetic predisposition to COVID-19 | 36 months | 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 |
| Microbiome-related response to COVID-19 | 36 months | 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 |
Countries
Italy
Contacts
Primary ContactMaria Rescigno, PhD
Outcome results
None listed