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CompletedNCT06191341CIVICUpdated Jan 8, 2024

Consequences in ICU of Vaccination Status of Covid-19 Patients

An observational study in SARS CoV 2 Infection, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,058
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • SARS CoV 2 Infection

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,058 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

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Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patient with Sars-Cov-2 pneumonia

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

Exclusion Criteria:

  • missing data for primary or secondary outcomes
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,058 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. World Health Organisation (WHO) clinical progression scale

    highest score during hospital stay

    Time frame: at hospital discharge

Secondary outcomes

  1. Mortality

    Rate

    Time frame: at D28 after hospital admission

  2. Prognosis factors

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

    Time frame: at hospital admission

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Study locations

1 site
  • CHR Metz-Thionville/Hopital Mercy
    Metz, 57085, France
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References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06191341
Lead sponsor
Centre Hospitalier Régional Metz-Thionville
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Jan 1, 2023
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Jan 8, 2024

Study contacts

Guillaume LOUIS, MD
principal investigator · CHR Metz Thionville Hopital Mercy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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