Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549831
Status:
RECRUITING
Last Update Posted:
2022-11-04
First Post:
2020-09-11
Brief Title:
Genetic Bases of COVID-19 Clinical Variability
Sponsor:
University of Siena
Organization:
University of Siena
Study Overview
Official Title:
Identification of the Genetic Bases Determining COVID-19 Clinical Variability in the Italian Population
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEN-COVID
Brief Summary:
GEN-COVID multicenter study aims to identify the genetic variants of the host genome responsible for the clinical variability of patients with COVID-19 This variability to date is only partially related to the age and comorbidities of patients The primary objective of the study is therefore to identify genetic variants associated with the severity of the disease while the secondary objective consists in the identification of variants associated with longitudinal disease trajectories
This is a laboratory study that involves the conduct of genetic investigations including whole exome sequencing and genome wide association studies on human biological material from patients affected by COVID-19
Clinical information useful to describe the level of disease severity will be also collected for each enrolled patient
A total of at least 2000 COVID-19 patients is expected to be included
This is a laboratory study that involves the conduct of genetic investigations including whole exome sequencing and genome wide association studies on human biological material from patients affected by COVID-19
Clinical information useful to describe the level of disease severity will be also collected for each enrolled patient
A total of at least 2000 COVID-19 patients is expected to be included
Detailed Description:
The outbreak of the coronavirus disease 2019 COVID-19 the Severe Acute Respiratory Syndrome caused by SARS-CoV-2 that first appeared in December 2019 in Wuhan Huanan Hubei Province of China has resulted in millions of cases worldwide within a few short months and rapidly evolving into a real pandemic The COVID-19 pandemic represents an enormous challenge to the worlds healthcare systems Among the European countries Italy was the first to experience the epidemic wave of SARS-CoV-2 infection accompanied by a severe clinical picture and a mortality rate reaching 14
The disease is characterized by a highly heterogeneous phenotypic response to SARS-CoV-2 infection with the large majority of infected individuals having only mild or even no symptoms However the severe cases can rapidly evolve towards a critical respiratory distress syndrome and multiple organ failure The symptoms of COVID-19 range from fever cough sore throat congestion and fatigue to shortness of breath hemoptysis pneumonia followed by respiratory disorders and septic shocks
The GEN-COVID is a multicentre academic observational study designed to collect and systematize biological samples and clinical data across multiple hospitals and healthcare facilities in Italy with the purpose of deriving patient-level phenotypic and genotypic data The project aims to identify the genetic determinants of COVID-19 clinical variability studying host genetics Genetic analyses will include Genome Wide Association Studies performed by the Institute of Molecular Medicine in Finland FIMM and Whole Exome Sequencing WES performed by the University of Siena SARS-CoV-2 infected individuals swab virus PCR-positive showing clinical different severity will be collected In particular enrolled subjects will include only adults subjects with age higher or equal to 18 years with the following clinical status types asymptomatic individuals home care patients with mild symptoms and hospitalized patients i-those requiring invasive ventilation ii-those requiring non-invasive ventilation ie CPAP and BiPAP and high-flows oxygen therapy iii- those requiring conventional oxygen therapy and iv-those not requiring oxygen therapy
Funding MIUR project Dipartimenti di Eccellenza 2018-2020 to Department of Medical Biotechnologies University of Siena Italy Private donors for COVID research Italian DL n18 March 17 2020
The disease is characterized by a highly heterogeneous phenotypic response to SARS-CoV-2 infection with the large majority of infected individuals having only mild or even no symptoms However the severe cases can rapidly evolve towards a critical respiratory distress syndrome and multiple organ failure The symptoms of COVID-19 range from fever cough sore throat congestion and fatigue to shortness of breath hemoptysis pneumonia followed by respiratory disorders and septic shocks
The GEN-COVID is a multicentre academic observational study designed to collect and systematize biological samples and clinical data across multiple hospitals and healthcare facilities in Italy with the purpose of deriving patient-level phenotypic and genotypic data The project aims to identify the genetic determinants of COVID-19 clinical variability studying host genetics Genetic analyses will include Genome Wide Association Studies performed by the Institute of Molecular Medicine in Finland FIMM and Whole Exome Sequencing WES performed by the University of Siena SARS-CoV-2 infected individuals swab virus PCR-positive showing clinical different severity will be collected In particular enrolled subjects will include only adults subjects with age higher or equal to 18 years with the following clinical status types asymptomatic individuals home care patients with mild symptoms and hospitalized patients i-those requiring invasive ventilation ii-those requiring non-invasive ventilation ie CPAP and BiPAP and high-flows oxygen therapy iii- those requiring conventional oxygen therapy and iv-those not requiring oxygen therapy
Funding MIUR project Dipartimenti di Eccellenza 2018-2020 to Department of Medical Biotechnologies University of Siena Italy Private donors for COVID research Italian DL n18 March 17 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None