COVID-19VIRIONUMNCT04887142
Predictors of Disease Severity in COVID-19 Patients
An observational study of COVID-19, run by Zeljko Mijailovic at 5 sites in 5 countries.
Trial summary
The primary goal of the VIRIONUM project is to analyze the association of clinical, socio-demographic characteristics of patients and their genetic polymorphism, inflammatory and other biochemical markers with disease progression and death in subjects with COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Standard of health care
- How many people
- 818 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 4 Apr 2020to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of both sexes with different socio-demographic and clinical characteristics, who were hospitalized due to COVID-19. The decision on hospitalization and further treatment of patients is at the discretion of the attending physicians. All participants will be prospectively followed during their hospital stay. Patients will be included in the study if they are at least 18 years old and if they give voluntary written consent to participate. Pregnant and breastfeeding women, patients transferred from other hospitals and those who die during the first 24 hours of hospitalization will be excluded. In this study, stratification of participants according to age to those older than 65 years and younger is provided only for the purposes of statistical data processing and analyse.
Who may be able to join
- Adult age, 18 years old or more
- 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
Who cannot join
- Pregnant and breastfeeding women
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Bosnia and Herzegovina1 site
General Hospital "Prim. dr. Abdulah Nakaš"
Sarajevo
Serbia1 site
Faculty of Medical Sciences, University Clinical Center Kragujevac
Kragujevac, Srbija, 34000
About this study
Official title: Biochemical, Inflammatory and Genetic Factors in Patients With COVID-19
The primary goal of the VIRIONUM project is to analyze the association of clinical, socio-demographic characteristics of patients and their genetic polymorphism, inflammatory and other biochemical markers with disease progression and death in subjects with COVID-19 disease. The research is an observational, cohort study with nested-case control design, including adult, male and female COVID-19 inpatients. Primary dependent variable will be outcome of disease, defined as discharge from the hospital or death. The outcomes and putative risk factors will be analyzed using binary logistic regressions. The proposed multi- and inter-disciplinary study should provide additional scientific evidence about risk factors for the development of severe forms of the disease and the COVID-19-related death.
Read the detailed description
Background: Severe acute respiratory syndrome 2 (SARS-CoV-2) is etiological agent of heterogeneous corona-virus disease 19 (COVID-19), which clinical condition range from asymptomatic or mild to critically severe with high odds for fatal outcome. Since the pathophysiological pathways of COVID-19 disease development are not fully elucidated, resulting in repeated changes in treatment plans, there is an unmet need for more research into genetic, biochemical, immunological, and clinical predictive indicators of better outcomes in COVID-19 patients.
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
- COVID-19
- Being tested
- Standard of health care
- Keywords
- COVID-19, Inpatients, Risk Factors, Treatment Outcome, Observational Study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of health careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The discharged subjects | The COVID-19 inpatients treated with standard care who survived the disease and discharged from hospital. Receives: Other: Standard of health care | |
| The deceased subjects | The COVID-19 inpatients treated with standard care who died from the disease. Receives: Other: Standard of health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Fatal Outcome
Case fatality ratio will be calculated as the proportion of patients who died from all causes (all-cause mortality) compared to the total number of patients
Measured: Up to 6 weeks from recruitment to hospital discharge or death
Secondary outcomes (1)
Ordinal Scale for Clinical Improvement
Patients' COVID-19 severity and clinical improvement will be assessed according to the recommendations of World Health Organization using Ordinal Scale for Clinical Improvement and the patient state will be classified as mild (score 4 or less) or severe (score 5 or more).
Measured: Up to 6 weeks from recruitment to hospital discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start4 Apr 2020
- Primary completion12 May 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeljko Mijailovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeljko Mijailovic, University of Kragujevac
- Investigators
- Dejan Baskic, MD PHD, Study chair, Faculty of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887142
- Sponsor's protocol ID
- 01/20-405
- Acronym
- VIRIONUM
- Status last verified
- Apr 2026
- First submitted
- 8 May 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical, Inflammatory and Genetic Factors in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04887142
- Acronym / sponsor ID
- VIRIONUM / 01/20-405
- Conditions
- COVID-19
- Keywords
- COVID-19, Inpatients, Risk Factors, Treatment Outcome, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Zeljko MijailovicUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the VIRIONUM project is to analyze the association of clinical, socio-demographic characteristics of patients and their genetic polymorphism, inflammatory and other biochemical markers with disease progression and death in subjects with COVID-19 disease. The research is an observational, cohort study with nested-case control design, including adult, male and female COVID-19 inpatients. Primary dependent variable will be outcome of disease, defined as discharge from the hospital or death. The outcomes and putative risk factors will be analyzed using binary logistic regressions. The proposed multi- and inter-disciplinary study should provide additional scientific evidence about risk factors for the development of severe forms of the disease and the COVID-19-related death.
Detailed description
Background: Severe acute respiratory syndrome 2 (SARS-CoV-2) is etiological agent of heterogeneous corona-virus disease 19 (COVID-19), which clinical condition range from asymptomatic or mild to critically severe with high odds for fatal outcome. Since the pathophysiological pathways of COVID-19 disease development are not fully elucidated, resulting in repeated changes in treatment plans, there is an unmet need for more research into genetic, biochemical, immunological, and clinical predictive indicators of better outcomes in COVID-19 patients.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The discharged subjects | – | Other: Standard of health careThe COVID-19 inpatients treated with standard care who survived the disease and discharged from hospital. |
| The deceased subjects | – | Other: Standard of health careThe COVID-19 inpatients treated with standard care who died from the disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of both sexes with different socio-demographic and clinical characteristics, who were hospitalized due to COVID-19. The decision on hospitalization and further treatment of patients is at the discretion of the attending physicians. All participants will be prospectively followed during their hospital stay. Patients will be included in the study if they are at least 18 years old and if they give voluntary written consent to participate. Pregnant and breastfeeding women, patients transferred from other hospitals and those who die during the first 24 hours of hospitalization will be excluded. In this study, stratification of participants according to age to those older than 65 years and younger is provided only for the purposes of statistical data processing and analyse.
Key inclusion criteria (4 listed)
- Adult age, 18 years old or more
- 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
Key exclusion criteria (4 listed)
- Pregnant and breastfeeding women
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of health careThe 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. | Other | The deceased subjects, The discharged subjects |
Primary outcome
Number of Participants with Fatal Outcome
Time frame: Up to 6 weeks from recruitment to hospital discharge or death
Case fatality ratio will be calculated as the proportion of patients who died from all causes (all-cause mortality) compared to the total number of patients
1 secondary outcome
Ordinal Scale for Clinical Improvement
Time frame: Up to 6 weeks from recruitment to hospital discharge or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dejan Baskic, MD PHD study chair
Faculty of Medical Sciences
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Zeljko Mijailovic at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Albania, Bosnia and Herzegovina, Croatia, Montenegro, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Fatal Outcome (time frame: Up to 6 weeks from recruitment to hospital discharge or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.