Clinical trial NCT04845997: COVID-19 Vaccination in Patients With Rheumatic Diseases
Official title: NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Diseases
Keywords: SARS-CoV-2
COVID-19 Vaccines
Lead sponsor: Sociedad Argentina de Reumatologia
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: COVID-19 Vaccine efficacy
timeFrame: 12 month
measure: COVID-19 Vaccine safety
timeFrame: 12 month
Secondary outcomes:
measure: New immunomediated events
timeFrame: 12 month
measure: Flare
timeFrame: 12 months
measure: Changes in the rheumatic disease treatment
timeFrame: 12 months
measure: Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases
timeFrame: 12 months
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Sociedad Argentina de Reumatología
state: Caba
city: Buenos Aires
country: Argentina
facility: Sociedad Argentina de Reumatologia
Study officials:
affiliation: Unidad de Investigación Sociedad Argentina Reumatología
name: Carolina Isnardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isnardi CA, Schneeberger EE, Kreimer JL, Luna PC, Echeverria C, Roberts K, de la Vega MC, Virasoro BM, Landi M, Quintana R, Exeni MED, Kogan N, Petkovic I, Pereira D, De Los Angeles Correa M, Zelaya MD, Tissera Y, Elkin MSG, Pisoni CN, Alonso C, Cogo AK, Cosatti MA, Garcia L, Retamozo C, de Los Angeles Severina M, Nieto RE, Rosemffet M, Mussano E, Bertoli A, Savio VG, Cosentino V, Pons-Estel GJ. An Argentinean cohort of patients with rheumatic and immune-mediated diseases vaccinated for SARS-CoV-2: the SAR-CoVAC Registry-protocol and preliminary data. Clin Rheumatol. 2022 Oct;41(10):3199-3209. doi: 10.1007/s10067-022-06253-5. Epub 2022 Jun 28.