Predictors of Disease Severity in COVID-19 Patients

COVID-19 Clinical Trial

— VIRIONUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887142
• Other study ID #: 01/20-405
• Status: Recruiting
• Start date: April 4, 2020
• Est. completion date: May 2023

Study information

• Verified date: May 2021
• Source: University of Kragujevac
• Contact: Zeljko Mijailovic, MD PhD
• Phone: +381 64 1675986
• Email: drmijailovic70[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1019
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Albania	Spitali Amerikan	Tirana
Bosnia and Herzegovina	General Hospital "Prim. dr. Abdulah Nakaš"	Sarajevo
Croatia	KBC Rijeka, University of Rijeka	Rijeka
Montenegro	University of Montenegro, Faculty of Medicine	Podgorica
Serbia	Faculty of Medical Sciences, University Clinical Center Kragujevac	Kragujevac	Srbija

Sponsors (1)

Lead Sponsor	Collaborator
Zeljko Mijailovic

Countries where clinical trial is conducted

Albania,  Bosnia and Herzegovina,  Croatia,  Montenegro,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 weeks from recruitment to hospital discharge or death
Secondary	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).	Up to 6 weeks from recruitment to hospital discharge or death