Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832022
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-03-31
Brief Title:
Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms CIRs Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms CIRs Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-RIC3
Brief Summary:
To date studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations
Detailed Description:
Longitudinal comparative controlled observational multicenter study based on a cohort of 1500 SARS-CoV-2 seronegative patients with CIRs from the COVID-RIC1 cohort 750 accepting vaccination and 750 refusing vaccination matched on age -10 years gender rheumatism and recruiting center Schedule 4 visits over a 12-month period
An observational routine care study was initiated in 15 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs The project plans to screen 5000 CIRs patients The COVID-RIC3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against COVID-19 based on a question asked at the time of their inclusion in COVID-RIC1
The efficacy and safety of the SARS-CoV2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with CIRs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of boost or booster
An observational routine care study was initiated in 15 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs The project plans to screen 5000 CIRs patients The COVID-RIC3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against COVID-19 based on a question asked at the time of their inclusion in COVID-RIC1
The efficacy and safety of the SARS-CoV2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with CIRs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of boost or booster
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None