Caracterisation of COVID-19 Patients Hospitalized in Infectious Disease Department

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; SARS-CoV Infection
• Intervention / Treatment: Other: Hospitalisation for SARS-COV2 infection

• Study Type: Observational
• Enrollment (Anticipated): 1300

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • Recruiting
    • CHU de NICE - Infectiologie
    • Contact: Elisa DEMONCHY; Phone Number: +33492035847; Email: 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
  • Nice, France, 06200
    • Recruiting
    • CHU de NICE - Urgences
    • Contact: Julie CONTENTI; Email: contenti.j@chu-ice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for SARS-COV2 infection

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics	Describe the clinical characteristic of patients hospitalized for SARS-CoV- 2 infection Identify factors associated with the COVID-19 disease severity	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	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	34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient hospitalised for Covid-19	Inpatient up to Day 28 or discharge	34 months
Overall Inpatient Mortality	Number of death due to Covid-19	34 months
Requirement for mechanical ventilation	Number of patients requiring mechanical ventilation	34 months
ICU Length of Stay (LOS)	Duration measured in days	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.	34 months
Biological tests	Dosage of Lymphocytes, C-reactive protein and IL-6	34 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: 21infectiocovid01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data sharing plan is scheduled

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No