Covid19COVID-19NCT05151094
Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center
An observational study of Covid19 and Thrombosis, run by University Hospital Dubrava at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Thrombosis, Bleeding
- What is being tested?
- Observation
- How many people
- 6,000 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2021to 1 Jan 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients that were hospitalized in our institution due to the COVID-19 infection
Who may be able to join
- all hospitalized patients positive for COVID-19
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Covid19, Thrombosis, Bleeding, Sepsis, Mechanical Ventilation Complication, Inflammatory Response
- Being tested
- Observation
- Medical subject headings
- COVID-19, Thrombosis, Hemorrhage, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of clinical outcomes and comparison to non-treated patients
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir exposure | Patients treated with remdesivir due to the COVID-19 infection Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Incidence of death from any cause
Measured: At 30-days from hospital admission
Secondary outcomes (5)
Incidence of venous or arterial thrombotic events
Incidence of arterial or venous thromboses proven by objective imaging (ultrasound, computerized tomography, magnetic resonance imaging, scintigraphy) and laboratory (troponin) methods.
Measured: At 30-days from hospital admission
Incidence of major bleeding
Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.
Measured: At 30-days from hospital admission
Incidence of bacteriemia
Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.
Measured: At 30-days from hospital admission
Incidence of mechanical ventilation
Incidence of mechanical ventilation use required for deteriorating respiratory function.
Measured: At 30-days from hospital admission
Incidence of intensive care unit admission
Incidence of intensive care unit admission required for intensive/critical level of care.
Measured: At 30-days from hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Apr 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Lucijanić, University Hospital Dubrava
- Investigators
- Marko Lucijanic, MD PhD, Study director, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151094
- Sponsor's protocol ID
- 2021/2503-04
- Acronym
- COVID-19
- Status last verified
- May 2023
- First submitted
- 20 Sep 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucijanic M, Krecak I, Cicic D, Milosevic M, Vukoja D, Kovacevic I, Marasovic I, Sedinic Lacko M, Bakovic J, Jonjic Z, Vasilj T, Stojic J, Atic A. Hypoosmolar and hyperosmolar COVID-19 patients are predisposed to dismal clinical outcomes. Scand J Clin Lab Invest. 2023 Oct;83(6):397-402. doi: 10.1080/00365513.2023.2241368. Epub 2023 Aug 2.
PubMed 37529905
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center
- ClinicalTrials.gov ID
- NCT05151094
- Acronym / sponsor ID
- COVID-19 / 2021/2503-04
- Conditions
- Covid19, Thrombosis, Bleeding, Sepsis, Mechanical Ventilation Complication, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remdesivir exposure | – | Other: ObservationPatients treated with remdesivir due to the COVID-19 infection |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that were hospitalized in our institution due to the COVID-19 infection
Key inclusion criteria (1 listed)
- all hospitalized patients positive for COVID-19
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation of clinical outcomes and comparison to non-treated patients | Other | Remdesivir exposure |
Primary outcome
Mortality
Time frame: At 30-days from hospital admission
Incidence of death from any cause
5 secondary outcomes
Incidence of venous or arterial thrombotic events
Time frame: At 30-days from hospital admission
Incidence of major bleeding
Time frame: At 30-days from hospital admission
Incidence of bacteriemia
Time frame: At 30-days from hospital admission
Incidence of mechanical ventilation
Time frame: At 30-days from hospital admission
Incidence of intensive care unit admission
Time frame: At 30-days from hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 37529905Lucijanic M, Krecak I, Cicic D, Milosevic M, Vukoja D, Kovacevic I, Marasovic I, Sedinic Lacko M, Bakovic J, Jonjic Z, Vasilj T, Stojic J, Atic A. Hypoosmolar and hyperosmolar COVID-19 patients are predisposed to dismal clinical outcomes. Scand J Clin Lab Invest. 2023 Oct;83(6):397-402. doi: 10.1080/00365513.2023.2241368. Epub 2023 Aug 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Lucijanic, MD PhD study director
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Thrombosis, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: At 30-days from hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.