Covid19NCT04779021
Caracterisation of COVID-19 Patients Hospitalized in Infectious Disease Department
An observational study of Covid19 and SARS-CoV Infection, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
The main objective of this cohort is to characterize COVID-19 patients hospitalized in infectious disease department. The collection of clinical and biological data from start of hospitalization to long-term follow up will contribute to a better description of the patient care, to the identification of predisposition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Hospitalisation for SARS-COV2 infection
- How many people
- 1,300 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Feb 2020to 31 Dec 2022
- 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: Patients hospitalized for SARS-COV2 infection
Who may be able to join
- Age > or = to 18
- Patients hospitalised for SARS-CoV-2 infection confirmed by RT PCRand/or CT scan and/or serology
Who cannot join
- Patients for whom SARS-CoV-2 infection has not been confirmed
Trial locations and contacts
2 sites in 1 country.
Elisa DEMONCHY contact
France2 sites, 2 recruiting
- Recruiting
CHU de NICE - Infectiologie
Nice, 06200
Elisa DEMONCHY, +33492035847, demonchy.e@chu-nice.fr
David CHIRIO, MD
- Recruiting
CHU de NICE - Urgences
Nice, 06200
Julie CONTENTI, contenti.j@chu-ice.fr
About this study
Official title: Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department
The main objective of this cohort is to characterize COVID-19 patients hospitalized in infectious disease department. The collection of clinical and biological data from start of hospitalization to long-term follow up will contribute to a better description of the patient care, to the identification of predisposition to complication related to the disease, and to the evaluation of the impact of different therapeutical strategies.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Hospitalisation for SARS-COV2 infection
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalisation for SARS-COV2 infectionOther
Patients hospitalized for SARS-COV2 infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics
Describe the clinical characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity
Measured: 34 months
Biological characteristics
Describe the biological characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity
Measured: 34 months
Radiological characteristics
Describe the radiological characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity
Measured: 34 months
Secondary outcomes (6)
Number of patient hospitalised for Covid-19
Inpatient up to Day 28 or discharge
Measured: 34 months
Overall Inpatient Mortality
Number of death due to Covid-19
Measured: 34 months
Requirement for mechanical ventilation
Number of patients requiring mechanical ventilation
Measured: 34 months
ICU Length of Stay (LOS)
Duration measured in days
Measured: 34 months
Evolution of patient general state during hospitalisation
the different measures (Body Mass Index (BMI), respiratory rate at rest, peripheral oxygen saturation, need for oxygen supplementation, body temperature) will be aggregated in order to obtain a clinical status corresponding to the clinical evolution (good or bad) of the patient's general state.
Measured: 34 months
Biological tests
Dosage of Lymphocytes, C-reactive protein and IL-6
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Feb 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779021
- Sponsor's protocol ID
- 21infectiocovid01
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: No data sharing plan is scheduled
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department
- ClinicalTrials.gov ID
- NCT04779021
- Acronym / sponsor ID
- 21infectiocovid01
- Conditions
- Covid19, SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Mar 2021 (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.
The main objective of this cohort is to characterize COVID-19 patients hospitalized in infectious disease department. The collection of clinical and biological data from start of hospitalization to long-term follow up will contribute to a better description of the patient care, to the identification of predisposition to complication related to the disease, and to the evaluation of the impact of different therapeutical strategies.
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
- Patients hospitalized for SARS-COV2 infection
Key inclusion criteria (2 listed)
- Age > or = to 18
- Patients hospitalised for SARS-CoV-2 infection confirmed by RT PCRand/or CT scan and/or serology
Key exclusion criteria (1 listed)
- Patients for whom SARS-CoV-2 infection has not been confirmed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospitalisation for SARS-COV2 infectionPatients hospitalized for SARS-COV2 infection | Other | – |
Primary outcome
Clinical characteristics
Time frame: 34 months
Describe the clinical characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity
Biological characteristics
Time frame: 34 months
Describe the biological characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity
Radiological characteristics
Time frame: 34 months
Describe the radiological characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity
6 secondary outcomes
Number of patient hospitalised for Covid-19
Time frame: 34 months
Overall Inpatient Mortality
Time frame: 34 months
Requirement for mechanical ventilation
Time frame: 34 months
ICU Length of Stay (LOS)
Time frame: 34 months
Evolution of patient general state during hospitalisation
Time frame: 34 months
Biological tests
Time frame: 34 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No. No data sharing plan is scheduled
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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.
Elisa DEMONCHY contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel CARLES (+33492035847, carles.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics (time frame: 34 months). The study lists 3 primary outcomes in all. 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 3 Mar 2021.