Predictors of Disease Severity in COVID-19 Patients

NCT04887142 | Completed

• 1 other identifier: 01/20-405
• Study Type: observational
• Target: 818
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; Inpatients; Risk Factors; Treatment Outcome; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ordinal Scale for Clinical Improvement

  Up to 6 weeks from recruitment to hospital discharge or death

Study Arms (2)

The discharged subjects

The COVID-19 inpatients treated with standard care who survived the disease and discharged from hospital.

Other: Standard of health care

The deceased subjects

The COVID-19 inpatients treated with standard care who died from the disease.

Other: Standard of health care

Interventions

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.

The deceased subjects; The discharged subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeljko Mijailovic: lead

Study Sites (5)

Spitali Amerikan

Tirana, Albania

Location

General Hospital "Prim. dr. Abdulah Nakaš"

Sarajevo, Bosnia and Herzegovina

Location

KBC Rijeka, University of Rijeka

Rijeka, Croatia

Location

University of Montenegro, Faculty of Medicine

Podgorica, Montenegro

Location

Faculty of Medical Sciences, University Clinical Center Kragujevac

Kragujevac, Srbija, 34000, Serbia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimen, serum, white cells.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dejan Baskic, MD PHD

  Faculty of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 14, 2021
• Study Start: April 4, 2020
• Primary Completion: May 12, 2023
• Study Completion: February 29, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AL (1); SE (1); BO (1); MO (1); CR (1)