Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

Active, not recruiting

• Conditions: Covid19; Inflammatory Response; Bleeding; Mechanical Ventilation Complication; Sepsis; Thrombosis
• Interventions: Other: Observation

• Registration Number: NCT05151094
• Lead Sponsor: University Hospital Dubrava

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.

Detailed Description

University Hospital Dubrava has been completely repurposed during the COVID-19 pandemic to become high volume COVID-19 tertiary institution. Establishment of hospital registry project is necessary to properly understand disease characteristic, related outcomes and real-life treatment patterns. Registry provides a fundamental framework for future upgrading with emerging or retrogradely obtained specific data that will substantially facilitate understanding of COVID-19 in the context of other specific diseases, therapies and procedures. Large comprehensive database will provide sufficient statistical power to allow for investigation of large number of subgroups and existence of interactions between different variables. Assessment of large number of clinically important outcomes (mortality, occurrence of venous and arterial thromboses, major bleeding, bacteriemia, incidence of mechanical ventilation and intensive care unit admission) is necessary to put any investigated parameter in the proper efficacy and safety context.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-12-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• all hospitalized patients positive for COVID-19

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remdesivir exposure	Observation	Patients treated with remdesivir due to the COVID-19 infection

Primary Outcome Measures

Name	Time	Method
Mortality	At 30-days from hospital admission	Incidence of death from any cause

Secondary Outcome Measures

Name	Time	Method
Incidence of mechanical ventilation	At 30-days from hospital admission	Incidence of mechanical ventilation use required for deteriorating respiratory function.
Incidence of venous or arterial thrombotic events	At 30-days from hospital admission	Incidence of arterial or venous thromboses proven by objective imaging (ultrasound, computerized tomography, magnetic resonance imaging, scintigraphy) and laboratory (troponin) methods.
Incidence of major bleeding	At 30-days from hospital admission	Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.
Incidence of intensive care unit admission	At 30-days from hospital admission	Incidence of intensive care unit admission required for intensive/critical level of care.
Incidence of bacteriemia	At 30-days from hospital admission	Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Grad Zagreb, Croatia