Consequences in ICU of Vaccination Status of Covid-19 Pat... | NCT06191341

Studies
Consequences in ICU of Vaccination Status of Covid-19 Patients

NCT06191341

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Jan 8, 2024Actual

Enrollment

1,058Actual

Phase

Not provided

Conditions

SARS CoV 2 Infection

Interventions

Not provided

Countries

France

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 2024

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

Jan 1, 2023Actual

Primary Completion Date

May 1, 2023Actual

Completion Date

May 1, 2023Actual

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 3, 2024

First Posted Date

Jan 5, 2024Actual

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 4, 2024

Last Update Posted Date

Jan 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

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

It is a retrospective cohort study aiming to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

Detailed Description

In December 2019 started the first wave of Sars-Cov-2 virus infections in Wuhan, China : the start of a major, deadly global pandemic, which has so far caused more than 6 million deaths worldwide. In response to the scale of this pandemic, a large-scale vaccination campaign was rapidly in place, starting in December 2020. Despite this measure, admission of vaccinated patients to intensive care has been noticed. The aim of this study is to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

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

1,058Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
World Health Organisation (WHO) clinical progression scale	highest score during hospital stay	at hospital discharge

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Rate	at D28 after hospital admission
Prognosis factors	Vaccinal status, SARS-COV2 variant, age, sex, BMI, SOFA score, hypertension, diabetus mellitus, immubodepression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient with Sars-Cov-2 pneumonia confirmed by positive reverse transcription polymerase chain reaction (RT-PCR) assay and hospitalized in the general intensive care unit of the CHR de Metz-Thionville, between 01/03/2020 and 01/06/2022.

Exclusion Criteria:

missing data for primary or secondary outcomes

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

Adult patient with Sars-Cov-2 pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume LOUIS, MD	CHR Metz Thionville Hopital Mercy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz-Thionville/Hopital Mercy		Metz		57085	France

IPD Sharing Statement Module

Plan to Share IPD

Description

According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.

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