The Fondazione Genomic SARS-CoV-2 Study COVID-19

NCT06549712 | Completed

• 1 other identifier: FOGS
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Genetic association at the genomic level (genomewide association study - GWAS), requencing by NGS (whole exome sequencing) and gene expression studies to identify the main ones hereditary genetic determinants of predisposition to the development of SARS (symptomatic pathology associated with development of insufficiency respiratory disease of any degree) in Italian subjects affected by SARSCoV-2.

Conditions

COVID-19; Genetic Predisposition

Outcome Measures

Primary Outcomes (1)

• SNPs as identified by GWAS

  We will measure the differences in genetic background between patients with severe SARS-CoV-2 infection and healthy controls from the same geographical area, and identify the genetic differences between patients with severe SARSCoV infection2 and those with mild or moderate infection.

  up to 36 months

Secondary Outcomes (1)

• rare genetic variants identified by Whole Exome sequencing (WES)

  up to 36 months

Study Arms (1)

identify the main common genetic determinants

EXPERIMENTAL

The purpose of the entire project is to identify genetic determinants of the predisposition to develop respiratory failure in persons infected by SARS-CoV-2; knowledge of these factors may educate the biological understanding of the development of severe lung disease in SARS-CoV-2 infection. Such an understanding may inform treatment trials of potential utility towards more effective management of this patient group. A polygenic risk score may also be useful in identifying high/low risk patients, e.g. amongst health-care providers and vulnerable individuals with significant comorbidities.

Genetic: genetic determinants to develop respiratory failure

Interventions

genetic determinants to develop respiratory failure GENETIC

To identify the main common genetic determinants of severe COVID-19 by conducting a GWAS: in first phase we will compare SARS-CoV-2 positive patients with severe lung affection to healthy controls from the same geographic area, in order to provide initial data informing the research in the field in a timely fashion. This will be conducted in close collaboration with the University of Kiel COVID-19 genomic initiative. Later on, we will proceed to assess objectives 1 and 2 in the full cohort, including also infected controls who did not developed clinically significant symptoms

identify the main common genetic determinants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• SARS-CoV-2 positive patients (no age limit) with severe pulmonary compromise, hospitalized with failure respiratory that requires support of any kind
• Signature of informed consent
• Blood donors (18-70 years old) who donated between 24/02/2020 and 31/12/2021
• exposure to the SARS-CoV-2 virus confirmed by viremia positive and presence of IgG/IgM
• Signature of informed consent
• Healthy controls available from previous studies (n=5,000, ages 14-80 years), whose data are already available for genetic association analyses within the Kiel University database.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, 20122, Italy

Location

MeSH Terms

Conditions

COVID-19; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: August 12, 2024
• Study Start: March 23, 2020
• Primary Completion: January 31, 2021
• Study Completion: May 31, 2023
• Last Updated: May 2, 2025

Record last verified: 2024-08

Locations

IT (1)