COVID-19COVIDEPI-SUIV'NCT05413694
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
A study testing telephone interview 24 months after hospitalization for Covid-19 in people with COVID-19, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- telephone interview 24 months after hospitalization for Covid-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteReunion
- Study dates
- Jul 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Reunion1 site
CHU de la Réunion
Saint-Pierre, 97448
Lucie AUZANNEAU
Léa BRUNEAU, ¨PH
About this study
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.
- Conditions
- COVID-19
- Being tested
- telephone interview 24 months after hospitalization for Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone interview 24 months after hospitalization for Covid-19Other
telephone interview 24 months after hospitalization for Covid-19
| Study group | Role | What they receive |
|---|---|---|
| telephone interview 24 months after hospitalization for Covid-19 | Experimental | telephone interview 24 months after hospitalization for Covid-19 Receives: Other: telephone interview 24 months after hospitalization for Covid-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 month
Secondary outcomes (2)
Determine the factors associated with the persistence of symptoms
Measured: 24 month
Measure physical and mental quality of life
Medical Outcome Study Short Form 12
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413694
- Sponsor's protocol ID
- 2022/CHU/04
- Acronym
- COVIDEPI-SUIV'
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
- ClinicalTrials.gov ID
- NCT05413694
- Acronym / sponsor ID
- COVIDEPI-SUIV' / 2022/CHU/04
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telephone interview 24 months after hospitalization for Covid-19 | Experimental | Other: telephone interview 24 months after hospitalization for Covid-19telephone interview 24 months after hospitalization for Covid-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone interview 24 months after hospitalization for Covid-19telephone interview 24 months after hospitalization for Covid-19 | Other | telephone interview 24 months after hospitalization for Covid-19 |
Primary outcome
cumulative incidence of patients with "persistent COVID-19"
Time frame: 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
2 secondary outcomes
Determine the factors associated with the persistence of symptoms
Time frame: 24 month
Measure physical and mental quality of life
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone interview 24 months after hospitalization for Covid-19 in people with COVID-19, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of patients with "persistent COVID-19" (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.