Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

NCT05151094 | Unknown

• 1 other identifier: 2021/2503-04
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this project is to understand clinical features, clinical outcomes and efficacy and safety profiles of different therapies by analyzing a cohort of COVID-19 patients hospitalized and treated in a tertiary-level institution, University hospital Dubrava. Patients' clinical and laboratory characteristics, drug exposure and outcomes are obtained by analysis of written and electronical medical records.

Conditions

Covid19; Thrombosis; Bleeding; Sepsis; Mechanical Ventilation Complication; Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• Mortality

  Incidence of death from any cause

  At 30-days from hospital admission

Secondary Outcomes (5)

• Incidence of venous or arterial thrombotic events

  At 30-days from hospital admission

• Incidence of major bleeding

  At 30-days from hospital admission

• Incidence of bacteriemia

  At 30-days from hospital admission

• Incidence of mechanical ventilation

  At 30-days from hospital admission

• Incidence of intensive care unit admission

  At 30-days from hospital admission

Study Arms (1)

Remdesivir exposure

Patients treated with remdesivir due to the COVID-19 infection

Other: Observation

Interventions

Observation OTHER

Observation of clinical outcomes and comparison to non-treated patients

Remdesivir exposure

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients that were hospitalized in our institution due to the COVID-19 infection

You may qualify if:

• all hospitalized patients positive for COVID-19

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, City of Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

COVID-19; Thrombosis; Hemorrhage; Sepsis

Interventions

Observation

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; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Marko Lucijanic, MD PhD

  University Hospital Dubrava

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: December 9, 2021
• Study Start: April 1, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)