COVIDEPI-SUIV': Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05413694
Collaborator
(none)
450
1
1
29
15.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: telephone interview 24 months after hospitalization for Covid-19
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: telephone interview 24 months after hospitalization for Covid-19

telephone interview 24 months after hospitalization for Covid-19

Other: telephone interview 24 months after hospitalization for Covid-19
telephone interview 24 months after hospitalization for Covid-19

Outcome Measures

Primary Outcome Measures

  1. cumulative incidence of patients with "persistent COVID-19" [24 month]

    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

  1. Determine the factors associated with the persistence of symptoms [24 month]

  2. Measure physical and mental quality of life [24 month]

    Medical Outcome Study Short Form 12

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de la Réunion Saint-Pierre Réunion 97448

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT05413694
Other Study ID Numbers:
  • 2022/CHU/04
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022