COVID-19 Vaccination in Patients With Rheumatic Diseases

Rheumatic Diseases Clinical Trial

— SAR-CoVAC  

Official title:

NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845997
• Other study ID #: 02
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Sociedad Argentina de Reumatologia
• Contact: Carolina Isnardi, MD
• Phone: +5491169583394
• Email: carolina.isnardi[@]reumatologia.org.ar
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.

Description:

This is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country. Patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed. The aim of this registry is to evaluate the efficacy and safety of the SARS-CoV-2 vaccines in patients with rheumatic diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years of age.
• Diagnosis of rheumatic disease treated or not with immunosuppressive agents
• Patients who have received at least one dose of a SARS-CoV-2 vaccine
• Signature of informed consent.

Exclusion Criteria:

• Patients who express their desire not to participate in the study or who are unable to give their informed consent.

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases

Intervention

Biological:
• COVID-19 Vaccine
Patients with rheumatic diseases who have been vaccinated for COVID-19

Locations

Country	Name	City	State
Argentina	Sociedad Argentina de Reumatologia	Buenos Aires
Argentina	Sociedad Argentina de Reumatología	Ciudad Autónoma de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Argentina de Reumatologia

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 Vaccine efficacy	Number of patients who develop SARS-CoV-2 infection after vaccination	12 month
Primary	COVID-19 Vaccine safety	Number of patients who develop adverse events asssociated with vaccination	12 month
Secondary	New immunomediated events	Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events.	12 month
Secondary	Flare	Number of patients who develop a flare asssociated with vaccination. Description	12 months
Secondary	Changes in the rheumatic disease treatment	Changes in the rheumatic disease treatment associated with vaccination, and study its influence on the efficacy (number of patients who develop SARS-CoV-2 infection after vaccination) and safety (number of patients who develop adverse events asssociated with vaccination) of the vaccine for SARS-CoV-2.	12 months
Secondary	Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases	Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases.	12 months