SARS CoV 2 InfectionCIVICNCT06191341
Consequences in ICU of Vaccination Status of Covid-19 Patients
An observational study of SARS CoV 2 Infection, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- How many people
- 1,058 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with Sars-Cov-2 pneumonia
Who may be able to join
- 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.
Who cannot join
- missing data for primary or secondary outcomes
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- SARS CoV 2 Infection
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organisation (WHO) clinical progression scale
highest score during hospital stay
Measured: at hospital discharge
Secondary outcomes (2)
Mortality
Rate
Measured: at D28 after hospital admission
Prognosis factors
Vaccinal status, SARS-COV2 variant, age, sex, BMI, SOFA score, hypertension, diabetus mellitus, immubodepression
Measured: at hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume LOUIS, MD, Principal investigator, CHR Metz Thionville Hopital Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191341
- Sponsor's protocol ID
- 2023-11Obs-CHRMT
- Acronym
- CIVIC
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences in ICU of Vaccination Status of Covid-19 Patients
- ClinicalTrials.gov ID
- NCT06191341
- Acronym / sponsor ID
- CIVIC / 2023-11Obs-CHRMT
- Conditions
- SARS CoV 2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,058 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with Sars-Cov-2 pneumonia
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- missing data for primary or secondary outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
World Health Organisation (WHO) clinical progression scale
Time frame: at hospital discharge
highest score during hospital stay
2 secondary outcomes
Mortality
Time frame: at D28 after hospital admission
Prognosis factors
Time frame: at hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume LOUIS, MD principal investigator
CHR Metz Thionville Hopital Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organisation (WHO) clinical progression scale (time frame: at hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.