COVID-19 Clinical Trial
— GEN-COVIDOfficial title:
Identification of the Genetic Bases Determining COVID-19 Clinical Variability in the Italian Population
NCT number | NCT04549831 |
Other study ID # | 16917 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 8, 2020 |
Est. completion date | April 8, 2026 |
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | April 8, 2026 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > or equal to 18 - SARS-CoV-2 PCR positive on swab Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Italy | University of Siena | Siena |
Lead Sponsor | Collaborator |
---|---|
University of Siena | ASST Fatebenefratelli Sacco, ASST Santi Paolo e Carlo, ASST Spedali Civili, Brescia, ASST Valtellina e Alto Lario, Azienda Ospedaliera dei Colli, Azienda Ospedaliera di Perugia, Azienda Ospedaliera Ospedale Maggiore di Crema, Azienda Ulss 2 Marca Trevigiana, Azienda USL Toscana Sud Est, Cardarelli Hospital, CEINGE Biotecnologie Avanzate, Napoli, Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, IRCSS Lazzaro Spallanzani, Roma, Istituti Ospitalieri di Cremona, Istituto Auxologico Italiano, Istituto Giannina Gaslini, Ospedale dell'Angelo, Venezia-Mestre, Ospedale della Misericordia, Ospedale Luigi Curto, Polla, Ospedale San Donato, Arezzo, ULSS1 Dolomiti, Belluno, University of Modena and Reggio Emilia |
Italy,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To identify the genetic determinants of COVID-19 severity | 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. | 6 years | |
Secondary | To identify the genetic determinants of COVID-19 clinical trajectories. | Identification of candidate gene(s) responsible for the COVID-19 clinical trajectories. | 6 years |
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