- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426253
Identification of Genetic Factors Determining Disease Course in the New Type of Coronavirus Infection, COVID-19
Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19
The study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study.
At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing.
Following the interim analysis, based on the results, another 800 people are planned to involve.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pécs, Hungary
- University of Pécs 1st Department of Internal Medicine Intensive Care Unit
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Pécs, Hungary
- University of Pécs First Department of Internal Medicine
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Pécs, Hungary
- University of Pécs Infection Department of the Coronavirus Center
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Pécs, Hungary
- University of Pécs Institute of Laboratory Medicine
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Pécs, Hungary
- University of Pécs Szentágotahi Research Centre
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Pécs, Hungary
- University of Pécs Szentágothai Research Centre Genomics and Bioinformatics Core Facility
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Pécs, Hungary
- University of Szeged Szentágothai Research Centre Virology Research Group
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Szeged, Hungary, 6720
- University of Szeged Department of Anaesthesiology And Inthensive Therapy
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Szeged, Hungary, 6720
- University of Szeged Department of Dermatology and Allergology
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Szeged, Hungary, 6720
- University of Szeged Department of Medical Biology
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Szeged, Hungary, 6720
- University of Szeged Department of Paediatrics
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Szeged, Hungary, 6720
- University of Szeged First Department of Medicine
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Szeged, Hungary, 6720
- University of Szeged Institute of Clinical Microbiology
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Szeged, Hungary, 6720
- University of Szeged Institute of Medical Microbiology and Immunobiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- confirmed covid 19 infection
Exclusion Criteria:
- informed refusal
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of genetic factors determining the course of the disease in case of COVID-19
Time Frame: 2020. December
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Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants
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2020. December
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Márta Széll, MD, Ph.D., University of Szeged, Department of Medical Genetics
Publications and helpful links
General Publications
- Danis J, Janovak L, Guban B, Goblos A, Szabo K, Kemeny L, Bata-Csorgo Z, Szell M. Differential Inflammatory-Response Kinetics of Human Keratinocytes upon Cytosolic RNA- and DNA-Fragment Induction. Int J Mol Sci. 2018 Mar 8;19(3):774. doi: 10.3390/ijms19030774.
- Chiu RW, Tang NL, Hui DS, Chung GT, Chim SS, Chan KC, Sung YM, Chan LY, Tong YK, Lee WS, Chan PK, Lo YM. ACE2 gene polymorphisms do not affect outcome of severe acute respiratory syndrome. Clin Chem. 2004 Sep;50(9):1683-6. doi: 10.1373/clinchem.2004.035436. No abstract available.
- Pinheiro DS, Santos RS, Jardim PCBV, Silva EG, Reis AAS, Pedrino GR, Ulhoa CJ. The combination of ACE I/D and ACE2 G8790A polymorphisms revels susceptibility to hypertension: A genetic association study in Brazilian patients. PLoS One. 2019 Aug 20;14(8):e0221248. doi: 10.1371/journal.pone.0221248. eCollection 2019.
- Scepanovic P, Alanio C, Hammer C, Hodel F, Bergstedt J, Patin E, Thorball CW, Chaturvedi N, Charbit B, Abel L, Quintana-Murci L, Duffy D, Albert ML, Fellay J; Milieu Interieur Consortium. Human genetic variants and age are the strongest predictors of humoral immune responses to common pathogens and vaccines. Genome Med. 2018 Jul 27;10(1):59. doi: 10.1186/s13073-018-0568-8.
- Dean L. Abacavir Therapy and HLA-B*57:01 Genotype. 2015 Sep 1 [updated 2018 Apr 18]. In: Pratt VM, Scott SA, Pirmohamed M, Esquivel B, Kattman BL, Malheiro AJ, editors. Medical Genetics Summaries [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2012-. Available from http://www.ncbi.nlm.nih.gov/books/NBK315783/
- Danis J, Goblos A, Gal B, Sulak A, Farkas K, Torok D, Varga E, Korom I, Kemeny L, Szell M, Bata-Csorgo Z, Nagy N. Nuclear Factor kappaB Activation in a Type V Pityriasis Rubra Pilaris Patient Harboring Multiple CARD14 Variants. Front Immunol. 2018 Jul 3;9:1564. doi: 10.3389/fimmu.2018.01564. eCollection 2018.
- Cao Y, Li L, Feng Z, Wan S, Huang P, Sun X, Wen F, Huang X, Ning G, Wang W. Comparative genetic analysis of the novel coronavirus (2019-nCoV/SARS-CoV-2) receptor ACE2 in different populations. Cell Discov. 2020 Feb 24;6:11. doi: 10.1038/s41421-020-0147-1. eCollection 2020. No abstract available.
- Teng DH, Chen Y, Lian L, Ha PC, Tavtigian SV, Wong AK. Mutation analyses of 268 candidate genes in human tumor cell lines. Genomics. 2001 Jun 15;74(3):352-64. doi: 10.1006/geno.2001.6551.
- Paoloni-Giacobino A, Chen H, Peitsch MC, Rossier C, Antonarakis SE. Cloning of the TMPRSS2 gene, which encodes a novel serine protease with transmembrane, LDLRA, and SRCR domains and maps to 21q22.3. Genomics. 1997 Sep 15;44(3):309-20. doi: 10.1006/geno.1997.4845. Erratum In: Genomics 2001 Sep;77(1-2):114.
- Lin M, Tseng HK, Trejaut JA, Lee HL, Loo JH, Chu CC, Chen PJ, Su YW, Lim KH, Tsai ZU, Lin RY, Lin RS, Huang CH. Association of HLA class I with severe acute respiratory syndrome coronavirus infection. BMC Med Genet. 2003 Sep 12;4:9. doi: 10.1186/1471-2350-4-9.
- Manczinger M, Boross G, Kemeny L, Muller V, Lenz TL, Papp B, Pal C. Pathogen diversity drives the evolution of generalist MHC-II alleles in human populations. PLoS Biol. 2019 Jan 31;17(1):e3000131. doi: 10.1371/journal.pbio.3000131. eCollection 2019 Jan.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID19_HUNGEN_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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