Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
2000 participants
OBSERVATIONAL
2020-04-08
2026-04-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Genotype and Susceptibility to COVID-19
NCT04799834
The Fondazione Genomic SARS-CoV-2 Study COVID-19
NCT06549712
Genetics of COVID-19 Susceptibility and Manifestations
NCT04371432
Genetic Predisposition to Severe Forms of COVID-19 (SARS-CoV2 Infection)
NCT04644146
Immunogenetics Predictors With COVID-19
NCT04390269
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* SARS-CoV-2 PCR positive on swab
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Ospedale San Donato, Arezzo
UNKNOWN
Ospedale della Misericordia
OTHER
Azienda Ospedaliera Ospedale Maggiore di Crema
OTHER
University of Modena and Reggio Emilia
OTHER
ASST Fatebenefratelli Sacco
OTHER
Azienda Ospedaliera di Perugia
OTHER
Ospedale dell'Angelo, Venezia-Mestre
OTHER
Azienda Ulss 2 Marca Trevigiana
OTHER
Cardarelli Hospital
OTHER
Azienda Ospedaliera dei Colli
OTHER
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
OTHER
Istituto Giannina Gaslini
OTHER
Istituti Ospitalieri di Cremona
OTHER
IRCSS Lazzaro Spallanzani, Roma
UNKNOWN
ASST Santi Paolo e Carlo
OTHER
ASST Valtellina e Alto Lario
UNKNOWN
Azienda USL Toscana Sud Est
OTHER_GOV
ULSS1 Dolomiti, Belluno
UNKNOWN
Asst Degli Spedali Civili Di Brescia
OTHER
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo
UNKNOWN
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Ospedale Luigi Curto, Polla
UNKNOWN
Istituto Auxologico Italiano
OTHER
CEINGE Biotecnologie Avanzate, Napoli
UNKNOWN
University of Siena
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesca Mari
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesca Mari, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Siena
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Siena
Siena, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Bergantini L, Baldassarri M, d'Alessandro M, Brunelli G, Fabbri G, Zguro K, Degl'Innocenti A; GEN-COVID Multicenter study; Fallerini C, Bargagli E, Renieri A. Ultra-rare RTEL1 gene variants associate with acute severity of COVID-19 and evolution to pulmonary fibrosis as a specific long COVID disorder. Respir Res. 2023 Jun 16;24(1):158. doi: 10.1186/s12931-023-02458-7.
Fallerini C, Daga S, Mantovani S, Benetti E, Picchiotti N, Francisci D, Paciosi F, Schiaroli E, Baldassarri M, Fava F, Palmieri M, Ludovisi S, Castelli F, Quiros-Roldan E, Vaghi M, Rusconi S, Siano M, Bandini M, Spiga O, Capitani K, Furini S, Mari F; GEN-COVID Multicenter Study; Renieri A, Mondelli MU, Frullanti E. Association of Toll-like receptor 7 variants with life-threatening COVID-19 disease in males: findings from a nested case-control study. Elife. 2021 Mar 2;10:e67569. doi: 10.7554/eLife.67569.
Related Links
Access external resources that provide additional context or updates about the study.
Employing a Systematic Approach to Biobanking and Analyzing Genetic and Clinical Data for Advancing COVID-19 Research
GEN-COVID: Impact of Host Genome on COVID-19 clinical variability
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16917
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.