NCT05589233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

October 20, 2022

Last Update Submit

December 7, 2023

Conditions

COVID-19VaccinationImmunityRespiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Vaccination status

    1.1.2021 - 30.6.2023

  • Vaccine efectiveness

    1.1.2021 - 30.6.2023

Study Arms (1)

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

Biological: Vaccionation eighter started or full course

Interventions

Vaccionation eighter started or full courseBIOLOGICAL

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

Patients COVID-19 positive admitted to the hospital

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

COVID-19Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 21, 2022

Study Start

January 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

CZ(1)