NCT05198453

Brief Summary

The aim of this study was to evaluate the association between vaccination with one of the four SARS-CoV-2 vaccines authorized for use in the European Union-BNT162b2, ChAdOx-1S, mRNA-1273 or Ad.26.COV2.S-and progression to critically severe disease among adult patients with PCR-confirmed acute COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
529

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 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

August 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 18, 2022

Last Update Submit

January 19, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • number (%) with critically severe disease

    assessment performed at a minimum 30 days after admission

Study Arms (2)

vaccinated patients with COVID-19

Biological: vaccination

unvaccinated patients with COVID-19

Interventions

vaccinationBIOLOGICAL

patients who received COVID-19 vaccine

vaccinated patients with COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized for acute COVID-19.

You may qualify if:

  • age 18 yers or more
  • hospitalized for acute COVID-19
  • PCR confirmed infection with SARS-CoV-2

You may not qualify if:

  • hospitalized for other conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Vaccination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 20, 2022

Study Start

August 16, 2021

Primary Completion

December 23, 2021

Study Completion

January 10, 2022

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations

SL(1)