Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1019 participants
OBSERVATIONAL
2020-04-04
2023-05-31
Brief Summary
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Detailed Description
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Aim: The VIRIONUM project's main aim is to investigate the relation between genetic polymorphisms, inflammatory and other biochemical markers, and disease severity and mortality in COVID-19-infected hospitalized patients.
Method and patients: The observational nested case-control clinical study will be conducted in at least 1019 COVID-19 patients. The genetic polymorphisms (ACE2, IFNL3/4 and TMPRSS2), serum concentration of soluble ACE2 and the pro- and anti-inflammatory cytokines, blood concentration of common inflammatory and other biomarkers, peripheral blood mononuclear leukocyte (PBMC) phenotype, demographic and clinical risk factors will be monitored as independent variables, while the dependent variables will be the outcome of the disease and the severity of the clinical condition. Genotyping will be performed by Real-Time PCR method, and serum concentrations of ACE2 and pro- and anti-inflammatory cytokines by ELISA method, and PBMC phenotype by flow cytometry. The disease severity will be assessed according to WHO criteria.
Expected results: The findings of this clinical study will contribute to understanding of significant genetic, biochemical, and clinical determinants of severity and lethal outcomes in COVID-19 patients, as well as, creation of set of recommendations for individuals at higher risk - future, evidence-based, targeted and individualized approach.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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The discharged subjects
The COVID-19 inpatients treated with standard care who survived the disease and discharged from hospital.
Standard of health care
The patients in this observational study will be exposed to the standard health care interventions according to the hospital diagnostic and treatment protocols and procedures and clinical judgment of the treating physicians.
The deceased subjects
The COVID-19 inpatients treated with standard care who died from the disease.
Standard of health care
The patients in this observational study will be exposed to the standard health care interventions according to the hospital diagnostic and treatment protocols and procedures and clinical judgment of the treating physicians.
Interventions
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Standard of health care
The patients in this observational study will be exposed to the standard health care interventions according to the hospital diagnostic and treatment protocols and procedures and clinical judgment of the treating physicians.
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Hospitalization for COVID-19 after confirmation by SARS-CoV-2 rapid antigen test or RT-PCR
* Voluntary written consent of the subject to participate
Exclusion Criteria
* Fatal outcome during the first 24 hours of hospitalization
* Inability to collect the necessary study data
* Declining of the subject to voluntary participate in the study
18 Years
ALL
No
Sponsors
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Zeljko Mijailovic
OTHER
Responsible Party
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Zeljko Mijailovic
Principal Investigator
Principal Investigators
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Dejan Baskic, MD PHD
Role: STUDY_CHAIR
Faculty of Medical Sciences
Locations
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Spitali Amerikan
Tirana, , Albania
General Hospital "Prim. dr. Abdulah Nakaš"
Sarajevo, , Bosnia and Herzegovina
KBC Rijeka, University of Rijeka
Rijeka, , Croatia
University of Montenegro, Faculty of Medicine
Podgorica, , Montenegro
Faculty of Medical Sciences, University Clinical Center Kragujevac
Kragujevac, Srbija, Serbia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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01/20-405
Identifier Type: -
Identifier Source: org_study_id
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