COVID-19 Vaccination in Patients With Rheumatic Diseases

NCT04845997 | Unknown DMC

• 1 other identifier: 02
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatic Diseases

Keywords

SARS-CoV-2; COVID-19 Vaccines

Outcome Measures

Primary Outcomes (2)

• COVID-19 Vaccine efficacy

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

  12 month

• COVID-19 Vaccine safety

  Number of patients who develop adverse events asssociated with vaccination

  12 month

Secondary Outcomes (4)

• New immunomediated events

  12 month

• Flare

  12 months

• Changes in the rheumatic disease treatment

  12 months

• Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases

  12 months

Interventions

COVID-19 Vaccine BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who express their desire not to participate in the study or who are unable to give their informed consent.

Sponsors & Collaborators

• Sociedad Argentina de Reumatologia: lead

Study Sites (2)

Sociedad Argentina de Reumatología

Buenos Aires, Buenos Aires F.D., 1022, Argentina

RECRUITING

Sociedad Argentina de Reumatologia

Buenos Aires, 1022, Argentina

RECRUITING

Related Publications (1)

• 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.

  PMID: 35760939 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Carolina Isnardi, MD

  Unidad de Investigación Sociedad Argentina Reumatología

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Isnardi, MD

CONTACT

+5491169583394; carolina.isnardi@reumatologia.org.ar

Guillermo Pons-Estel, PhD, MD

CONTACT

+5493412644125; unisar@reumatologia.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)