Caracterisation of COVID-19 Patients Hospitalized in Infectious Disease Department

• Conditions: Covid19; SARS-CoV Infection

• Registration Number: NCT04779021
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical characteristics	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	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	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

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

Trial Locations

Locations (2)

CHU de NICE - Urgences; 🇫🇷 Nice, France

CHU de NICE - Infectiologie; 🇫🇷 Nice, France