Caracterisation of COVID-19 Patients Hospitalized in Infectious Disease Department

Covid19 Clinical Trial

Official title:

Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779021
• Other study ID #: 21infectiocovid01
• Status: Recruiting
• Start date: February 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Michel CARLES
• Phone: +33492035847
• Email: carles.m[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Covid19
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU de NICE - Infectiologie	Nice
France	CHU de NICE - Urgences	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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