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SAR-CoVAC: COVID-19 Vaccination in Patients With Rheumatic Diseases

Sponsor
Sociedad Argentina de Reumatologia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04845997
Collaborator
(none)
3,000
Enrollment
2
Locations
30
Anticipated Duration (Months)
1500
Patients Per Site
50
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 Vaccine

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. COVID-19 Vaccine efficacy [12 month]

    Number of patients who develop SARS-CoV-2 infection after vaccination

  2. COVID-19 Vaccine safety [12 month]

    Number of patients who develop adverse events asssociated with vaccination

Secondary Outcome Measures

  1. New immunomediated events [12 month]

    Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events.

  2. Flare [12 months]

    Number of patients who develop a flare asssociated with vaccination. Description

  3. Changes in the rheumatic disease treatment [12 months]

    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.

  4. Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases [12 months]

    Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sociedad Argentina de Reumatología Ciudad Autónoma de Buenos Aires Caba Argentina 1022
2 Sociedad Argentina de Reumatologia Buenos Aires Argentina 1022

Sponsors and Collaborators

  • Sociedad Argentina de Reumatologia

Investigators

  • Principal Investigator: Carolina Isnardi, MD, Unidad de Investigación Sociedad Argentina Reumatología

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sociedad Argentina de Reumatologia
ClinicalTrials.gov Identifier:
NCT04845997
Other Study ID Numbers:
  • 02
First Posted:
Apr 15, 2021
Last Update Posted:
Aug 2, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sociedad Argentina de Reumatologia
SARS-CoV-2
COVID-19 Vaccines
Additional relevant MeSH terms:
Rheumatic Diseases
Collagen Diseases

Study Results

No Results Posted as of Aug 2, 2021