Sars-CoV-2 InfectionREPINCT06255860
COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk / World Health Organization (WHO)
An observational study of Sars-CoV-2 Infection and MIS-C, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV-2 Infection, MIS-C
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2023to 1 Apr 2024
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children with SARS-CoV-2 and children with MIS-C between the 01 sep 2021 and 30 apr 2022 period
Who may be able to join
- group 1: cases
- Patients with MIS-C (following SARS CoV-2 infection)
- Hospitalised between the 01 sep 2021 and 30 apr 2022
- Under 18 years of age
- Not vaccinated for SARS-CoV-2
- group 2: controls
Show all 10Show fewer
- Patients not hospitalised, treated by outpatient care
- With documented SARS-CoV-2 infection between the 01 sep 2021 and 30 apr 2022
- Matched with a case on age (+/- 6 months), gender and country
- Not vaccinated for SARS-CoV-2
Who cannot join
- Refusal to participate by patient relative or legal representative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-COV-2 (virus Responsible of COVID-19) Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.
Read the detailed description
This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.
The main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.
- Conditions
- Sars-CoV-2 Infection, MIS-C
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with MIS-C | hospitalized children with MIS-C | |
| SARS-CoV-2 infection | non hospitalized children infected with SARS-CoV-2 treated by outpatient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of MIS-C cases occurred after first SARS-CoV-2 infection
Assessment of risk of MIS-C after first SARS-CoV-2 infection
Measured: 8 months
proportion of MIS-C cases occurred after SARS-CoV-2 reinfection
Assessment of risk of MIS-C after SARS-CoV-2 reinfection
Measured: 8 months
Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start22 Sep 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Levy, Physician, Study director, Association Clinique Thérapeutique Infantile du val de MarneNaim Ouldali, Physician, Principal investigator, Hôpital Robert Debré AP-HP, Paris 19
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255860
- Sponsor's protocol ID
- REPI
- Acronym
- REPI
- Status last verified
- Nov 2024
- First submitted
- 7 Feb 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV-2 (virus Responsible of COVID-19) Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
- ClinicalTrials.gov ID
- NCT06255860
- Acronym / sponsor ID
- REPI / REPI
- Conditions
- Sars-CoV-2 Infection, MIS-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 13 Feb 2024 (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.
This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.
Detailed description
This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.
The main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with MIS-C | – | –hospitalized children with MIS-C |
| SARS-CoV-2 infection | – | –non hospitalized children infected with SARS-CoV-2 treated by outpatient care |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children with SARS-CoV-2 and children with MIS-C between the 01 sep 2021 and 30 apr 2022 period
Key inclusion criteria (10 listed)
- group 1: cases
- Patients with MIS-C (following SARS CoV-2 infection)
- Hospitalised between the 01 sep 2021 and 30 apr 2022
- Under 18 years of age
- Not vaccinated for SARS-CoV-2
Key exclusion criteria (1 listed)
- Refusal to participate by patient relative or legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of MIS-C cases occurred after first SARS-CoV-2 infection
Time frame: 8 months
Assessment of risk of MIS-C after first SARS-CoV-2 infection
proportion of MIS-C cases occurred after SARS-CoV-2 reinfection
Time frame: 8 months
Assessment of risk of MIS-C after SARS-CoV-2 reinfection
Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
Time frame: 8 months
Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Sars-CoV-2 Infection
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.
Corinne Levy, Physician study director
Association Clinique Thérapeutique Infantile du val de Marne
Naim Ouldali, Physician principal investigator
Hôpital Robert Debré AP-HP, Paris 19
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV-2 Infection and MIS-C, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
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 10 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of MIS-C cases occurred after first SARS-CoV-2 infection (time frame: 8 months). The study lists 3 primary outcomes in all. 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 21 Nov 2024.