COVID-19 Vaccination AZV 2021-2023

COVID-19 Clinical Trial

Official title:

Clinical Phenotype of Persons Vaccinated Against Sars-CoV-2 Hospitalized for COVID-19 Disease as a Basis for Optimalization of National Vaccination Strategy and Post-exposure Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589233
• Other study ID #: AZVCR_FNHK_9302
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Immunity
• Respiratory Failure
• Respiratory Insufficiency
• Vaccination

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