Predictors of Disease Severity in COVID-19 Patients

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spitali Amerikan, Tirana, Albania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Standard of health care

Other

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.

Primary outcomes

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

Secondary outcomes

Ordinal Scale for Clinical Improvement

Time frame: Up to 6 weeks from recruitment to hospital discharge or death

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).

Sponsors and collaborators

Lead sponsor

Zeljko Mijailovic

Other

Registry information

Official study title

Biochemical, Inflammatory and Genetic Factors in Patients With COVID-19

Acronym: VIRIONUM

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2024
First posted: May 14, 2021
Registry last updated: Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed