<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426253</url>
  </required_header>
  <id_info>
    <org_study_id>COVID19_HUNGEN_001</org_study_id>
    <nct_id>NCT04426253</nct_id>
  </id_info>
  <brief_title>Identification of Genetic Factors Determining Disease Course in the New Type of Coronavirus Infection, COVID-19</brief_title>
  <official_title>Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to identify environmental factors and genetic (gene mutation and gene&#xD;
      expression) changes, which influencing the course of the disease the new type of coronavirus&#xD;
      infection COVID-19 in patients nationwide in a multicenter study.&#xD;
&#xD;
      At first in the study will be performed 200 patients, selected for a homogeneous groups on&#xD;
      the basis of the patient's anamnestic data, genetic testing.&#xD;
&#xD;
      Following the interim analysis, based on the results, another 800 people are planned to&#xD;
      involve.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of genetic factors determining the course of the disease in case of COVID-19</measure>
    <time_frame>2020. December</time_frame>
    <description>Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>COVID-19</condition>
  <condition>Sars-CoV2</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, nose and throat swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed covid 19 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  informed refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Márta Széll, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Szeged, Department of Medical Genetics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pécs 1st Department of Internal Medicine Intensive Care Unit</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pécs First Department of Internal Medicine</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pécs Infection Department of the Coronavirus Center</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pécs Institute of Laboratory Medicine</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pécs Szentágotahi Research Centre</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pécs Szentágothai Research Centre Genomics and Bioinformatics Core Facility</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Szentágothai Research Centre Virology Research Group</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Department of Anaesthesiology And Inthensive Therapy</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Department of Dermatology and Allergology</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Department of Medical Biology</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Department of Paediatrics</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged First Department of Medicine</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Institute of Clinical Microbiology</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged Institute of Medical Microbiology and Immunobiology</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <link>
    <url>https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases</url>
    <description>COVID-19 situation update worldwide</description>
  </link>
  <link>
    <url>https://www.worldometers.info/coronavirus/country/italy/</url>
    <description>Total Coronavirus Cases in Italy</description>
  </link>
  <link>
    <url>https://edition.cnn.com/2020/03/19/health/new-jersey-coronavirus-family-members-killed/index.html</url>
    <description>Coronavirus kills 4 family members and sickens others after a dinner in New Jersey</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>29518010</PMID>
  </reference>
  <reference>
    <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. doi: 10.1373/clinchem.2004.035436. No abstract available.</citation>
    <PMID>15331509</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>31430320</PMID>
  </reference>
  <reference>
    <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 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.</citation>
    <PMID>30053915</PMID>
  </reference>
  <reference>
    <citation>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/</citation>
    <PMID>28520363</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>30018619</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>32133153</PMID>
  </reference>
  <reference>
    <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. doi: 10.1006/geno.2001.6551.</citation>
    <PMID>11414763</PMID>
  </reference>
  <reference>
    <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. Erratum In: Genomics 2001 Sep;77(1-2):114.</citation>
    <PMID>9325052</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12969506</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30703088</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426253
org study id: COVID19_HUNGEN_001
nct id: NCT04426253
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Identification of genetic factors determining the course of the disease in case of COVID-19
time frame: 2020. December
description: Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants
Blood, nose and throat swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Márta Széll, MD, Ph.D.
role: Principal Investigator
affiliation: University of Szeged, Department of Medical Genetics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hungary
url: https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases
description: COVID-19 situation update worldwide
url: https://www.worldometers.info/coronavirus/country/italy/
description: Total Coronavirus Cases in Italy
url: https://edition.cnn.com/2020/03/19/health/new-jersey-coronavirus-family-members-killed/index.html
description: Coronavirus kills 4 family members and sickens others after a dinner in New Jersey
citation: 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
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. doi: 10.1373/clinchem.2004.035436. No abstract available.
PMID: 15331509
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.
PMID: 31430320
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 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
citation: 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/
PMID: 28520363
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.
PMID: 30018619
citation: 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
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. doi: 10.1006/geno.2001.6551.
PMID: 11414763
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. Erratum In: Genomics 2001 Sep;77(1-2):114.
PMID: 9325052
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.
PMID: 12969506
citation: 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
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Disease Progression
sharing ipd: No