COVID-19 Vaccination in Patients With Rheumatic Diseases (SAR-CoVAC)

July 27, 2021 updated by: Sociedad Argentina de Reumatologia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Vaccine efficacy
Time Frame: 12 month
Number of patients who develop SARS-CoV-2 infection after vaccination
12 month
COVID-19 Vaccine safety
Time Frame: 12 month
Number of patients who develop adverse events asssociated with vaccination
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New immunomediated events
Time Frame: 12 month
Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events.
12 month
Flare
Time Frame: 12 months
Number of patients who develop a flare asssociated with vaccination. Description
12 months
Changes in the rheumatic disease treatment
Time Frame: 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.
12 months
Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases
Time Frame: 12 months
Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Argentina de Reumatologia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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