COVID-19 Vaccination AZV 2021-2023

Completed

• Conditions: COVID-19; Vaccination; Immunity; Respiratory Failure
• Interventions: Biological: Vaccionation eighter started or full course

• Registration Number: NCT05589233
• Lead Sponsor: University Hospital Hradec Kralove

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-21
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• adult patients
• COVID-19 positiveness
• vaccination against SARS-CoV-2 (any number of doses)

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients COVID-19 positive admitted to the hospital	Vaccionation eighter started or full course	COVID-19-positive patients admitted eighter to the standard ward or intensive care unit who were vaccinated against SARS-Cov-2

Primary Outcome Measures

Name	Time	Method
Patient phenotype	1.1.2021 - 30.6.2023	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.

Secondary Outcome Measures

Name	Time	Method
Vaccination status	1.1.2021 - 30.6.2023	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.
Vaccine efectiveness	1.1.2021 - 30.6.2023	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.

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia