Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island (COVIDEPI-SUIV')
Primary Purpose
COVID-19
Status
Not yet recruiting
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
telephone interview 24 months after hospitalization for Covid-19
Sponsored by
About this trial
This is an interventional other trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- over 18 years old
- having been hospitalized at the University Hospital Center (CHU) of Reunion (minimum of one night in the hospital)
- with a positive diagnosis of COVID-19 (positive RT(reverse transcription)-PCR(Polymerase Chain Reaction) SARS-CoV-2 on a nasopharyngeal swab or positive serology or confirmed diagnosis in the medical file)
- registered in the COVIDEPI database
- whose telephone numbers are available in the computerized patient file
- residing on the island of Reunion
- knowing how to understand and speak French
Exclusion Criteria:
- deceased
- opposing the use of their data
- deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curators
Sites / Locations
- CHU de la Réunion
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
telephone interview 24 months after hospitalization for Covid-19
Arm Description
telephone interview 24 months after hospitalization for Covid-19
Outcomes
Primary Outcome Measures
cumulative incidence of patients with "persistent COVID-19"
presence (at the time of the interview or in the month preceding the interview) of at least one symptom among the most frequent prolonged symptoms of COVID-19 and which was not present before the interview SARS (severe acute respiratory syndrome )-CoV-2 infection
Secondary Outcome Measures
Determine the factors associated with the persistence of symptoms
Measure physical and mental quality of life
Medical Outcome Study Short Form 12
Full Information
NCT ID
NCT05413694
First Posted
June 9, 2022
Last Updated
June 9, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT05413694
Brief Title
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
Acronym
COVIDEPI-SUIV'
Official Title
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The island of Reunion, a French overseas department of 860,000 inhabitants, located in the Indian Ocean (OI) zone, recorded its first case of COVID-19 on March 11, 2020. The epidemic, which was described as not very severe during the year 2020 in Reunion was much more intense and more deadly in 2021, with the arrival of the new variants (South African and Indian) and exploded at the beginning of the year 2022 (variant Omicron).
Reunion has a specific island context both climato-geographically and demographically. Indeed, this French island located in the southern hemisphere in the middle of the Indian Ocean (OI) has a tropical climate and a multi-ethnic population, younger than in mainland France (16% are over 60 years old). It is also marked by a higher prevalence in the general population of certain risk factors, such as obesity (11%) and type 2 diabetes (>10%), recognized as factors favoring severe clinical forms of COVID-19. as well as "persistent COVID-19".
This study will allow the constitution of a large-scale French cohort located in a closed overseas territory to provide answers to local specificities and to the management of the epidemic in the territory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
telephone interview 24 months after hospitalization for Covid-19
Arm Type
Experimental
Arm Description
telephone interview 24 months after hospitalization for Covid-19
Intervention Type
Other
Intervention Name(s)
telephone interview 24 months after hospitalization for Covid-19
Intervention Description
telephone interview 24 months after hospitalization for Covid-19
Primary Outcome Measure Information:
Title
cumulative incidence of patients with "persistent COVID-19"
Description
presence (at the time of the interview or in the month preceding the interview) of at least one symptom among the most frequent prolonged symptoms of COVID-19 and which was not present before the interview SARS (severe acute respiratory syndrome )-CoV-2 infection
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Determine the factors associated with the persistence of symptoms
Time Frame
24 month
Title
Measure physical and mental quality of life
Description
Medical Outcome Study Short Form 12
Time Frame
24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
over 18 years old
having been hospitalized at the University Hospital Center (CHU) of Reunion (minimum of one night in the hospital)
with a positive diagnosis of COVID-19 (positive RT(reverse transcription)-PCR(Polymerase Chain Reaction) SARS-CoV-2 on a nasopharyngeal swab or positive serology or confirmed diagnosis in the medical file)
registered in the COVIDEPI database
whose telephone numbers are available in the computerized patient file
residing on the island of Reunion
knowing how to understand and speak French
Exclusion Criteria:
deceased
opposing the use of their data
deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie AUZANNEAU
Phone
0262359949
Ext
+262
Email
lucie.auzanneau@chu-reunion.fr
Facility Information:
Facility Name
CHU de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
First Name & Middle Initial & Last Name & Degree
Léa BRUNEAU, ¨PH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
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