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COVID-19 Vaccination AZV 2021-2023

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05589233
Enrollment
3000
Registered
2022-10-21
Start date
2021-01-01
Completion date
2023-11-30
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Immunity, Respiratory Failure, Vaccination

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.

Interventions

BIOLOGICALVaccionation eighter started or full course

Vaccination against SARS-CoV-2 at any number of doses

Sponsors

University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Patient phenotype1.1.2021 - 30.6.2023Clinical 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

MeasureTime frameDescription
Vaccine efectiveness1.1.2021 - 30.6.2023Assessment 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.
Vaccination status1.1.2021 - 30.6.2023Defining 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026