COVID-19NCT05589233
COVID-19 Vaccination AZV 2021-2023
An observational study of COVID-19 and Vaccination, run by University Hospital Hradec Kralove at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Vaccination, Immunity
- What is being tested?
- Vaccionation eighter started or full course
- Type of treatment
- Vaccines
- How many people
- 3,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2021to 30 Nov 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients admitted to the standard ward or intensive care unit with COVID-19 positive test and any number of vaccination doses against SARS-CoV-2.
Who may be able to join
- adult patients
- COVID-19 positiveness
- vaccination against SARS-CoV-2 (any number of doses)
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Vaccination, Immunity, Respiratory Failure
- Being tested
- Vaccionation eighter started or full course
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccionation eighter started or full courseBiological
Vaccination against SARS-CoV-2 at any number of doses
| Study group | Role | What they receive |
|---|---|---|
| Patients COVID-19 positive admitted to the hospital | COVID-19-positive patients admitted eighter to the standard ward or intensive care unit who were vaccinated against SARS-Cov-2 Receives: Biological: Vaccionation eighter started or full course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.1.2021 - 30.6.2023
Secondary outcomes (2)
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.
Measured: 1.1.2021 - 30.6.2023
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.
Measured: 1.1.2021 - 30.6.2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jan 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Černá Pařízková, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589233
- Sponsor's protocol ID
- AZVCR_FNHK_9302
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05589233
- Acronym / sponsor ID
- AZVCR_FNHK_9302
- Conditions
- COVID-19, Vaccination, Immunity, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Oct 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients COVID-19 positive admitted to the hospital | – | Biological: Vaccionation eighter started or full courseCOVID-19-positive patients admitted eighter to the standard ward or intensive care unit who were vaccinated against SARS-Cov-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the standard ward or intensive care unit with COVID-19 positive test and any number of vaccination doses against SARS-CoV-2.
Key inclusion criteria (3 listed)
- adult patients
- COVID-19 positiveness
- vaccination against SARS-CoV-2 (any number of doses)
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Vaccionation eighter started or full courseVaccination against SARS-CoV-2 at any number of doses | Biological | Patients COVID-19 positive admitted to the hospital |
Primary outcome
Patient phenotype
Time frame: 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.
2 secondary outcomes
Vaccination status
Time frame: 1.1.2021 - 30.6.2023
Vaccine efectiveness
Time frame: 1.1.2021 - 30.6.2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Vaccination, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 3 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: finished, as of the sponsor's last update on 8 Dec 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient phenotype (time frame: 1.1.2021 - 30.6.2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.