Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549712
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-03-07
Brief Title:
The Fondazione Genomic SARS-CoV-2 Study COVID-19
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Fondazione Genomic SARS-CoV-2 Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOGS
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
Detailed Description:
Lombardy region in Northern Italy is now in the midst of an outbreak of severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 the virus that causes coronavirus disease 2019 COVID-19 The COVID-19 epidemic situation needs little introduction and represent a global world-wide emergency with mortality rates rapidly increasing in Europe and the US Evidence is accumulating that the majority of individuals infected by SARS-CoV-2 are asymptomatic and the major source of viral spread 3 and that a considerable fraction of these has active viral replication 45 Furthermore disease behavior is variable with the majority of patients experiencing only mild symptoms or no symptoms at all Some patients develop severe pulmonary affection with aggressive and extensive inflammatory destruction of lung parenchyma and associated inflammatory responses and superinfections driving large fractions of the COVID-19 related mortality What exactly drives this development of severe lung disease remains unknown but old age obesity diabetes and other co-morbidities increase the risk while the role played by specific medications is still uncertain Variation in virus genetics and patient immunology are also likely involved As to the latter point we hypothesize that host genetics may play a role in determining development of severe lung disease in SARS-CoV-2 infection Genome-wide association studies GWAS have been applied to decipher the genetic predisposition in thousands of disease traits since the study design was invented in 2005 The genetic signals detected vary from very strong effects that can be detected in a few hundred individuals to very weak effects requiring cohorts of tens of thousands for detection By 2020 the study design is now a robust off-the-shelf easyto-perform industry-standard screening tool for genetic predisposition even available through consumer genetics online-based companies The study design is simple testing for genetic variants throughout the genome single nucleotide polymorphisms SNPs using SNP microarrays comparing their frequencies in patients versus controls or across other variables For inflammatory phenotypes in particular GWAS has proven an efficient tool delineating hundreds of susceptibility loci in many conditions some of which has provided novel and surprising disease insights GWAS serve two purposes Most importantly they allow to determine biological factors involved in disease development thus potentially guiding drug development and therapy This would be particularly relevant during the current COVID-19 emergency when hundreds of trials have begun and there is an urgent need to prioritize well-conducted collaborative studies based on robust pathophysiological data Secondly and increasingly popular they allow for the calculation of a polygenic risk score to predict disease development Both aspects appear crucial to clarify for COVID-19 lung disease a are there genetic signatures suggesting which biological mechanisms are involved that may suggest relevant therapeutic approaches and b can we predict those at risk or those with very low risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None