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NCT Number: NCT06191341

Consequences in ICU of Vaccination Status of Covid-19 Patients

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.

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Key information

Conditions

SARS CoV 2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. World Health Organisation (WHO) clinical progression scale

    Time frame: at hospital discharge

    highest score during hospital stay

Secondary outcomes

  1. Mortality

    Time frame: at D28 after hospital admission

    Rate

  2. Prognosis factors

    Time frame: at hospital admission

    Vaccinal status, SARS-COV2 variant, age, sex, BMI, SOFA score, hypertension, diabetus mellitus, immubodepression

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: CIVIC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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