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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
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 9, 2022
Last Updated
June 9, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
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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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