Status:
COMPLETED
COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Rheumatic Disease
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with chronic rheumatic diseases (such as systemic lupus erythematosus \[SLE\], rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], juvenile idiopathic arthritis \[JIA\], poly/dermatom...
Detailed Description
A sample of 1254 patients with rheumatic diseases and 542 healthy controls matched for age and sex was calculated as follows. 1.A) Evaluation of patients with SLE compared to a healthy control group ...
Eligibility Criteria
Inclusion
- RA patients according to the classification criteria of the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR).
- Patients with axial spondyloarthritis (ASAS criteria 2009) and psoriatic arthritis (CASPAR 2012 criteria).
- SLE patients according to the SLICC classification criteria.
- SSc patients according to the ACR preliminary criteria.
- Patients with inflammatory myopathies according to the Bohan and Peter's criteria.
- Patients with primary vasculitis.
- Patients with pSS (2002 American-European Consensus group criteria and/or 2016 classification criteria of the EULAR/ACR.
- Patients with primary APS (primary antiphospholipid syndrome) (Sydney classification criteria).
- Patients with HIV-related illness.
Exclusion
- History of anaphylactic response to vaccine components.
- Acute febrile illness.
- Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease.
- History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks before.
- History of having received blood products up to 6 months before the study.
- Individuals who do not accept to participate in the study and/or whose guardians do not agree to participate in the study.
- Hospitalized patients.
- Patients with severe conditions requiring hospitalization.
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2024
Estimated Enrollment :
2196 Patients enrolled
Trial Details
Trial ID
NCT04754698
Start Date
February 9 2021
End Date
March 22 2024
Last Update
March 26 2024
Active Locations (1)
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1
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil, 05403000