Impact of Vaccination in Acute COVID-19 | NCT05198453

Studies
Impact of Vaccination in Acute COVID-19

NCT05198453

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Feb 3, 2022Actual

Enrollment

529Actual

Phase

Not provided

Conditions

COVID-19

Interventions

vaccination

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2021Actual

Primary Completion Date

Dec 23, 2021Actual

Completion Date

Jan 10, 2022Actual

First Submitted Date

Jan 18, 2022

First Submission Date that Met QC Criteria

Jan 18, 2022

First Posted Date

Jan 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2022

Last Update Posted Date

Feb 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daša Stupica, Principal Investigator, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

529Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vaccinated patients with COVID-19			Biological: vaccination
unvaccinated patients with COVID-19

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaccination	Biological	patients who received COVID-19 vaccine	vaccinated patients with COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number (%) with critically severe disease		assessment performed at a minimum 30 days after admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized for acute COVID-19.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Ljubljana		Ljubljana			Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

After a reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014611	Vaccination

Ancestor Terms

ID	Term
D016233	Immunotherapy, Active
D007114	Immunization
D007167	Immunotherapy
D056747	Immunomodulation

Browse Leaves

Not provided

Browse Branches

Not provided