Impact of Vaccination in Acute COVID-19
January 19, 2022 updated by: Daša Stupica, University Medical Centre Ljubljana
The Impact of Vaccination in a Cohort of Patients Hospitalized for Acute COVID-19
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
529
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ljubljana, Slovenia
- University Medical Center Ljubljana
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized for acute COVID-19.
Description
Inclusion Criteria:
- age 18 yers or more
- hospitalized for acute COVID-19
- PCR confirmed infection with SARS-CoV-2
Exclusion Criteria:
- hospitalized for other conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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vaccinated patients with COVID-19
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patients who received COVID-19 vaccine
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unvaccinated patients with COVID-19
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number (%) with critically severe disease
Time Frame: assessment performed at a minimum 30 days after admission
|
assessment performed at a minimum 30 days after admission
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 16, 2021
Primary Completion (ACTUAL)
December 23, 2021
Study Completion (ACTUAL)
January 10, 2022
Study Registration Dates
First Submitted
January 18, 2022
First Submitted That Met QC Criteria
January 18, 2022
First Posted (ACTUAL)
January 20, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 3, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breakthrough covid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
After a reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.