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

NCT04426253 | Unknown

• 1 other identifier: COVID19_HUNGEN_001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

COVID-19; Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults

You may qualify if:

• confirmed covid 19 infection

You may not qualify if:

• informed refusal

Sponsors & Collaborators

• Szeged University: lead

Study Sites (14)

University of Pécs 1st Department of Internal Medicine Intensive Care Unit

Pécs, Hungary

Location

University of Pécs First Department of Internal Medicine

Pécs, Hungary

Location

University of Pécs Infection Department of the Coronavirus Center

Pécs, Hungary

Location

University of Pécs Institute of Laboratory Medicine

Pécs, Hungary

Location

University of Pécs Szentágotahi Research Centre

Pécs, Hungary

Location

University of Pécs Szentágothai Research Centre Genomics and Bioinformatics Core Facility

Pécs, Hungary

Location

University of Szeged Szentágothai Research Centre Virology Research Group

Pécs, Hungary

Location

University of Szeged Department of Anaesthesiology And Inthensive Therapy

Szeged, 6720, Hungary

Location

University of Szeged Department of Dermatology and Allergology

Szeged, 6720, Hungary

Location

University of Szeged Department of Medical Biology

Szeged, 6720, Hungary

Location

University of Szeged Department of Paediatrics

Szeged, 6720, Hungary

Location

University of Szeged First Department of Medicine

Szeged, 6720, Hungary

Location

University of Szeged Institute of Clinical Microbiology

Szeged, 6720, Hungary

Location

University of Szeged Institute of Medical Microbiology and Immunobiology

Szeged, 6720, Hungary

Location

Related Publications (11)

• 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.

  PMID: 29518010 BACKGROUND

• 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.

  PMID: 15331509 BACKGROUND

• 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.

  PMID: 31430320 BACKGROUND

• 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.

  PMID: 30053915 BACKGROUND

• Dean L. Abacavir Therapy and HLA-B*57:01 Genotype. 2015 Sep 1 [updated 2025 Apr 21]. 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/

  PMID: 28520363 BACKGROUND

• 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.

  PMID: 30018619 BACKGROUND

• 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.

  PMID: 32133153 BACKGROUND

• 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.

  PMID: 11414763 BACKGROUND

• 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.

  PMID: 9325052 BACKGROUND

• 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.

  PMID: 12969506 BACKGROUND

• 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.

  PMID: 30703088 BACKGROUND

Related Links

• COVID-19 situation update worldwide
• Total Coronavirus Cases in Italy
• Coronavirus kills 4 family members and sickens others after a dinner in New Jersey
• Association Between HLA Gene Polymorphism and the Genetic Susceptibility of SARS Infection

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nose and throat swab

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Márta Széll, MD, Ph.D.

  University of Szeged, Department of Medical Genetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 5, 2020
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (14)