COVID-19 Vaccination in Patients With Rheumatic Diseases

NCT ID: NCT04845997

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Rheumatic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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COVID-19 Vaccine

Patients with rheumatic diseases who have been vaccinated for COVID-19

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Argentina de Reumatologia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolina Isnardi, MD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Investigación Sociedad Argentina Reumatología

Locations

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Sociedad Argentina de Reumatología

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Sociedad Argentina de Reumatologia

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Carolina Isnardi, MD

Role: CONTACT

+5491169583394

Guillermo Pons-Estel, PhD, MD

Role: CONTACT

+5493412644125

Facility Contacts

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Guillermo Posn-Estel, PhD

Role: primary

+5493412644125

Carolina Isnardi, MD

Role: backup

+541169583394

Carolina Isnardi, MD

Role: primary

1169583394

Guillermo Pons Estel, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 35760939 (View on PubMed)

Other Identifiers

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02

Identifier Type: -

Identifier Source: org_study_id

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