Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caracterisation of COVID-19 Patients Hospitalized in Infectious Disease Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779021
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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 to complication related to the disease, and to the evaluation of the impact of different therapeutical strategies.

Condition or disease Intervention/treatment
Covid19 SARS-CoV Infection Other: Hospitalisation for SARS-COV2 infection

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Hospitalisation for SARS-COV2 infection
    Patients hospitalized for SARS-COV2 infection


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Number of patient hospitalised for Covid-19 [ Time Frame: 34 months ]
    Inpatient up to Day 28 or discharge

  2. Overall Inpatient Mortality [ Time Frame: 34 months ]
    Number of death due to Covid-19

  3. Requirement for mechanical ventilation [ Time Frame: 34 months ]
    Number of patients requiring mechanical ventilation

  4. ICU Length of Stay (LOS) [ Time Frame: 34 months ]
    Duration measured in days

  5. Evolution of patient general state during hospitalisation [ Time Frame: 34 months ]
    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.

  6. Biological tests [ Time Frame: 34 months ]
    Dosage of Lymphocytes, C-reactive protein and IL-6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized for SARS-COV2 infection
Criteria

Inclusion Criteria:

  • Age > or = to 18
  • Patients hospitalised for SARS-CoV-2 infection confirmed by RT PCRand/or CT scan and/or serology

Exclusion Criteria:

  • Patients for whom SARS-CoV-2 infection has not been confirmed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779021


Contacts
Layout table for location contacts
Contact: Michel CARLES +33492035847 carles.m@chu-nice.fr
Contact: Elisa DEMONCHY demonchy.e@chu-nice.fr

Locations
Layout table for location information
France
CHU de NICE - Infectiologie Recruiting
Nice, France, 06200
Contact: Elisa DEMONCHY    +33492035847    demonchy.e@chu-nice.fr   
Sub-Investigator: David CHIRIO, MD         
Sub-Investigator: Karine RISSO, MD         
Sub-Investigator: Eric CUA, MD         
Sub-Investigator: Johan COURJON, MD         
CHU de NICE - Urgences Recruiting
Nice, France, 06200
Contact: Julie CONTENTI       contenti.j@chu-ice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04779021    
Other Study ID Numbers: 21infectiocovid01
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing plan is scheduled

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases