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NCT04426253 Clinical Trial

Identification of Genetic Factors Determining Disease Course in the New Type of Coronavirus Infection, COVID-19

COVID-19 Clinical Trial

Official title:
Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04426253
Other study ID # COVID19_HUNGEN_001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 5, 2020
Est. completion date July 31, 2021

Study information
Verified date June 2020
Source Szeged University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date July 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- confirmed covid 19 infection

Exclusion Criteria:

- informed refusal

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hungary University of Pécs 1st Department of Internal Medicine Intensive Care Unit Pécs
Hungary University of Pécs First Department of Internal Medicine Pécs
Hungary University of Pécs Infection Department of the Coronavirus Center Pécs
Hungary University of Pécs Institute of Laboratory Medicine Pécs
Hungary University of Pécs Szentágotahi Research Centre Pécs
Hungary University of Pécs Szentágothai Research Centre Genomics and Bioinformatics Core Facility Pécs
Hungary University of Szeged Szentágothai Research Centre Virology Research Group Pécs
Hungary University of Szeged Department of Anaesthesiology And Inthensive Therapy Szeged
Hungary University of Szeged Department of Dermatology and Allergology Szeged
Hungary University of Szeged Department of Medical Biology Szeged
Hungary University of Szeged Department of Paediatrics Szeged
Hungary University of Szeged First Department of Medicine Szeged
Hungary University of Szeged Institute of Clinical Microbiology Szeged
Hungary University of Szeged Institute of Medical Microbiology and Immunobiology Szeged

Sponsors (1)
Lead Sponsor Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (11)

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. — View Citation

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. — View Citation

Danis J, Göblös A, Gál B, Sulák A, Farkas K, Török D, Varga E, Korom I, Kemény L, Széll M, Bata-Csörgö Z, Nagy N. Nuclear Factor ?B 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. — View Citation

Danis J, Janovák L, Gubán B, Göblös A, Szabó K, Kemény L, Bata-Csörgo Z, Széll M. Differential Inflammatory-Response Kinetics of Human Keratinocytes upon Cytosolic RNA- and DNA-Fragment Induction. Int J Mol Sci. 2018 Mar 8;19(3). pii: E774. doi: 10.3390/ijms19030774. — View Citation

Dean L. Abacavir Therapy and HLA-B*57:01 Genotype. 2015 Sep 1 [updated 2018 Apr 18]. In: Pratt VM, McLeod HL, Rubinstein WS, Scott SA, Dean LC, 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/ — View Citation

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. — View Citation

Manczinger M, Boross G, Kemény L, Müller V, Lenz TL, Papp B, Pál 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. — View Citation

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. Erratum in: Genomics 2001 Sep;77(1-2):114. — View Citation

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. — View Citation

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 Intérieur 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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of genetic factors determining the course of the disease in case of COVID-19 Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants 2020. December
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