Clinical trial NCT04426253: Identification of Genetic Factors Determining Disease Course in the New Type of Coronavirus Infection, COVID-19
Official title: Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Sars-CoV2
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults

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.


Eligibility criteria: Inclusion Criteria:

* confirmed covid 19 infection

Exclusion Criteria:

* informed refusal

Primary outcomes:
measure: Identification of genetic factors determining the course of the disease in case of COVID-19
timeFrame: 2020. December
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs 1st Department of Internal Medicine Intensive Care Unit
city: Pécs
country: Hungary
facility: University of Pécs First Department of Internal Medicine
city: Pécs
country: Hungary
facility: University of Pécs Infection Department of the Coronavirus Center
city: Pécs
country: Hungary
facility: University of Pécs Institute of Laboratory Medicine
city: Pécs
country: Hungary
facility: University of Pécs Szentágotahi Research Centre
city: Pécs
country: Hungary
facility: University of Pécs Szentágothai Research Centre Genomics and Bioinformatics Core Facility
city: Pécs
country: Hungary
facility: University of Szeged Szentágothai Research Centre Virology Research Group
city: Szeged
country: Hungary
facility: University of Szeged Department of Anaesthesiology And Inthensive Therapy
city: Szeged
country: Hungary
facility: University of Szeged Department of Dermatology and Allergology
city: Szeged
country: Hungary
facility: University of Szeged Department of Medical Biology
city: Szeged
country: Hungary
facility: University of Szeged Department of Paediatrics
city: Szeged
country: Hungary
facility: University of Szeged First Department of Medicine
city: Szeged
country: Hungary
facility: University of Szeged Institute of Clinical Microbiology
city: Szeged
country: Hungary
facility: University of Szeged Institute of Medical Microbiology and Immunobiology
Study officials:
affiliation: University of Szeged, Department of Medical Genetics
name: Márta Széll, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
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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. doi: 10.1006/geno.1997.4845.
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. doi: 10.1186/1471-2350-4-9.
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