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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05589233
Other study ID # AZVCR_FNHK_9302
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date November 30, 2023

Study information

Verified date December 2023
Source University Hospital Hradec Kralove
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is aimed at the clinical and laboratory characteristics of patients with completed vaccination against SARS-CoV-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of COVID-19.


Description:

The high number of patients hospitalized for COVID-19 significantly affects the entire healthcare system, where 70-80% of the total number of patients are unvaccinated, however, approximately 20-30% of patients hospitalized for the disease COVID-19 have undergone vaccination. The investigators assume the existence of several phenotypes of infection even in vaccinated patients, which may differ both in the rate of antibody formation, the dynamics of indicators of persistent virus replication, and the intensity of a potentially self-destructive inflammatory reaction and activation of coagulation. Early identification of patients with completed vaccination who have a higher risk of a severe course of COVID or a demonstrable inadequate immune response will allow individualization of treatment. Finding out the risk characteristics of the patients is a question and the difference in the type of vaccine on the severity of the course of hospitalization and the clinical outcome of the patients can contribute to the optimization of the vaccination strategy of the population and to the early identification of risk groups of vaccinated persons from the point of view of the timely deployment of available post-exposure prophylaxis/treatment procedures.


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients - COVID-19 positiveness - vaccination against SARS-CoV-2 (any number of doses) Exclusion Criteria: - N/A

Study Design


Intervention

Biological:
Vaccionation eighter started or full course
Vaccination against SARS-CoV-2 at any number of doses

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient phenotype Clinical and laboratory characteristics of patients with completed vaccination against SARS-CoV-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of COVID-19. 1.1.2021 - 30.6.2023
Secondary Vaccination status Defining the clinical phenotype of patients with completed vaccination against SARS-CoV-2 that is associated with the highest risk of severe course of the disease and/or death. 1.1.2021 - 30.6.2023
Secondary Vaccine efectiveness Assessment of the difference between the effectiveness of the vaccines used in relation to the need for admission of patients to intensive care unit and indicators of clinical outcome. 1.1.2021 - 30.6.2023
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