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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04845997
Other study ID # 02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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