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Genetic Bases of COVID-19 Clinical Variability (GEN-COVID)

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ClinicalTrials.gov Identifier: NCT04549831
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
Policlinico San Matteo Pavia Fondazione IRCCS
Ospedale San Donato, Arezzo
Ospedale della Misericordia
Azienda Ospedaliera Ospedale Maggiore di Crema
University of Modena and Reggio Emilia
ASST Fatebenefratelli Sacco
Azienda Ospedaliera di Perugia
Ospedale dell'Angelo, Venezia-Mestre
Azienda Ulss 2 Marca Trevigiana
Cardarelli Hospital
Azienda Ospedaliera dei Colli
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Istituto Giannina Gaslini
Istituti Ospitalieri di Cremona
IRCSS Lazzaro Spallanzani, Roma
ASST Santi Paolo e Carlo, Milano
ASST Valtellina e Alto Lario
Azienda USL Toscana Sud Est
ULSS1 Dolomiti, Belluno
ASST Spedali Civili, Brescia
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ospedale Luigi Curto, Polla
Istituto Auxologico Italiano
CEINGE Biotecnologie Avanzate, Napoli
Information provided by (Responsible Party):
Francesca Mari, Azienda Ospedaliera Universitaria Senese

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 2,000 COVID-19 patients is expected to be included.


Condition or disease Intervention/treatment
COVID-19 Genetic: Massive parallel sequencing of host genome

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 world's 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 i.e. 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 D.L. n.18 March 17, 2020).

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identification of the Genetic Bases Determining COVID-19 Clinical Variability in the Italian Population
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : April 8, 2021
Estimated Study Completion Date : April 8, 2026

Group/Cohort Intervention/treatment
SARS-CoV-2 PCR positive individuals
Adult (> o equal to 18 years) SARS-CoV-2 PCR positive individuals with different clinical outcome: from asymptomatic to severely affected COVID-19 patients.
Genetic: Massive parallel sequencing of host genome
Massive parallel sequencing and genotyping of host genome of individuals infected with SARS-CoV-2 and showing different clinical outcomes from asymptomatic to severely affected patients in order to identify the genetic determinants of severe COVID-19 and the genetic protective factors.




Primary Outcome Measures :
  1. To identify the genetic determinants of COVID-19 severity [ Time Frame: 6 years ]
    Identification of one or more candidate gene(s) responsible for the severe outcome and subsequent use of it/them for prognostic purposes and preventive treatment and/or care.


Secondary Outcome Measures :
  1. To identify the genetic determinants of COVID-19 clinical trajectories. [ Time Frame: 6 years ]
    Identification of candidate gene(s) responsible for the COVID-19 clinical trajectories.


Biospecimen Retention:   Samples With DNA
Whole blood and derivates such as plasma, serum, DNA, lymphocytes, lymphoblastic cell lines, naso/oro-pharyngeal swab and derivates such as RNA, DNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients, outpatients, asymptomatic individuals
Criteria

Inclusion Criteria:

  • Age > or equal to 18
  • SARS-CoV-2 PCR positive on swab

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549831


Contacts
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Contact: Alessandra Renieri, MD, PhD 00390577233303 alessandra.renieri@unisi.it

Locations
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Italy
University of Siena Recruiting
Siena, Italy, 53100
Contact: Alessandra Renieri, MD, PhD    00390577233303    alessandra.renieri@unisi.it   
Principal Investigator: Francesca Mari, MD, PhD         
Sponsors and Collaborators
University of Siena
Policlinico San Matteo Pavia Fondazione IRCCS
Ospedale San Donato, Arezzo
Ospedale della Misericordia
Azienda Ospedaliera Ospedale Maggiore di Crema
University of Modena and Reggio Emilia
ASST Fatebenefratelli Sacco
Azienda Ospedaliera di Perugia
Ospedale dell'Angelo, Venezia-Mestre
Azienda Ulss 2 Marca Trevigiana
Cardarelli Hospital
Azienda Ospedaliera dei Colli
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Istituto Giannina Gaslini
Istituti Ospitalieri di Cremona
IRCSS Lazzaro Spallanzani, Roma
ASST Santi Paolo e Carlo, Milano
ASST Valtellina e Alto Lario
Azienda USL Toscana Sud Est
ULSS1 Dolomiti, Belluno
ASST Spedali Civili, Brescia
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ospedale Luigi Curto, Polla
Istituto Auxologico Italiano
CEINGE Biotecnologie Avanzate, Napoli
Investigators
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Principal Investigator: Francesca Mari, MD, PhD University of Siena
Additional Information:
Publications:
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Responsible Party: Francesca Mari, Principal Investigator, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT04549831    
Other Study ID Numbers: 16917
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Relevant information coming from the genetic results of the study will be made available to the scientific community through the Network of Italian Genomes (NIG)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Already available
Access Criteria: Publicly available
URL: http://nigdb.cineca.it

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesca Mari, Azienda Ospedaliera Universitaria Senese:
COVID-19
SARS-CoV-2
Host Genetics
Genetic susceptibility