SAR-COVID: Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
Study Details
Study Description
Brief Summary
SAR-COVID is a national, multicenter, prospective, observational longitudinal registry of consecutive patients with diagnosis of rheumatic diseases treated or not with immunomodulatory and/or immunosuppressive drugs and SARS-CoV-2 infection (asymptomatic or COVID-19).
Hypothesis: Patients with rheumatic diseases who are under chronic treatment with immunomodulatory and/or immunosuppressive drugs more frequently have an asymptomatic infection, a milder COVID-19 and lower mortality than patients with rheumatic diseases without immunomodulatory and/or immunosuppressive treatments.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
SAR-COVID is a national, multicenter, prospective, observational longitudinal registry of consecutive patients with diagnosis of rheumatic diseases treated or not with immunomodulatory and/or immunosuppressive drugs and SARS-CoV-2 infection (asymptomatic or COVID-19).
HYPOTESIS: Patients with rheumatic diseases who are under chronic treatment with immunomodulatory and/or immunosuppressive drugs more frequently have an asymptomatic infection, a milder COVID-19 and lower mortality than patients with rheumatic diseases without immunomodulatory and/or immunosuppressive treatments.
TARGET POPULATION: Patients > 18 years of age with any rheumatic disease. ELIGIBILITY CRITERIA Inclusion Criteria
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Age > 18 years.
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Patients with diagnosis of rheumatic diseases (treated or not with immunomodulatory and/or immunosuppressive drugs).
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Patients with diagnosis of SARS-CoV-2 infection (past or present) with positive test for the virus SARS-CoV-2 from analysis of nasopharyngeal or oropharyngeal swab specimens (reverse transcriptase-polymerase- chain-reaction assay) or by serology, independently of symptoms.
Exclusion Criteria
• Patients who do not wish to participate or are unable to give informed consent.
RECRUITMENT: All rheumatologists, members of the Argentine Society of Rheumatology will be invited to participate in the registry. It is expected that 3,000 patients with COVID-19 and some rheumatic disease, who are cared for by rheumatologists in any of the 23 provinces of Argentina, will be enrolled in the SAR-COVID registry during the period from July 1 to December 31, 2020. Twelve-month extension of the recruitment period will be applied if the expected number of patients is not achieved by the end of the inclusion date. Two cohorts will be included: the first will enroll 1,500 patients treated with immunomodulatory and/or immunosuppressive drugs, and the second will enroll 1,500 patients without immunomodulatory and/or immunosuppressive drugs.
DATA COLLECTION: All variables will be collected by self-report, clinical and laboratory examination and/or medical records review, performed by the rheumatologist during patient hospitalization due to COVID-19, or at the patient control visit performed after SARS-CoV-2 infection. The data will be entered into the ARTHROS eCRF (online application designed ad hoc), which in turn will facilitate generating queries and perform the statistical analysis.
PERIODIC REPORTS: Patients will be followed up for 12 months, in order to evaluate their evolution and identify the effect of the SARS-CoV-2 infection on their rheumatological disease. For this reason, in this registry the data will be collected in two phases:
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PHASE I: Corresponds to the baseline visit (T0). Sociodemographic data, diagnosis, symptoms, treatment, hospitalization, complications, characteristics of the rheumatic disease and its treatment before and during the infectious process will be recorded.
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PHASE II: This second visit (T1) will be carried out 12 months after patients registration. Its objective is to identify long-term complications after SARS-CoV-2 infection and to assess the impact of infection on rheumatic disease.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Treated with immunomodulatory and/or -suppressive drugs Patients with rheumatic diseases treated with immunomodulatory and/or immunosuppressive drugs and with diagnosis of SARS-CoV-2 infection (past or present) with positive test for the virus SARS-CoV-2 from analysis of nasopharyngeal or oropharyngeal swab specimens (reverse transcriptase-polymerase- chain-reaction assay) or by serology, independently of symptoms. |
Drug: Immunosuppressive Agents
Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician
Other Names:
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Not treated with immunomodulatory and/or -suppressive drugs Patients with rheumatic diseases not treated with immunomodulatory and/or immunosuppressive drugs and with diagnosis of SARS-CoV-2 infection (past or present) with positive test for the virus SARS-CoV-2 from analysis of nasopharyngeal or oropharyngeal swab specimens (reverse transcriptase-polymerase- chain-reaction assay) or by serology, independently of symptoms. |
Outcome Measures
Primary Outcome Measures
- Mortality [2 month]
Death caused by SARS-CoV-2 infection
- Hospitalization [2 month]
Hospitalization because of SARS-CoV-2 infection
Secondary Outcome Measures
- SARS-CoV-2 infection presentation [1 month]
To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases
- Admission at the intensive care unit [2 month]
Proportion of patients admitted at the intensive care unit
- Invasive mechanical ventilation [2 month]
Proportion of patients who required invasive mechanical ventilation
- COVID-19 Complications [2 month]
Proportion of patients who had complications associated with COVID-19 infection and describe them
- Recovery rate [2 month]
Proportion of patients fully or partially recovered after COVID-19 infection.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age equal or older than 18 years.
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Patients with diagnosis of rheumatic diseases (treated or not with immunomodulatory and/or immunosuppressive drugs).
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Patients with diagnosis of SARS-CoV-2 infection (past or present) with positive test for the virus SARS-CoV-2 from analysis of nasopharyngeal or oropharyngeal swab specimens (reverse transcriptase-polymerase- chain-reaction assay) or by serology, independently of symptoms.
Exclusion Criteria:
- Patients who do not wish to participate or are unable to give informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sociedad Argentina de Reumatología | Ciudad Autónoma de Buenos Aires | Caba | Argentina | 1022 |
Sponsors and Collaborators
- Sociedad Argentina de Reumatologia
Investigators
- Study Director: Guillermo Pons-Estel, Unidad de Investigación Sociedad Argentina Reumatología
Study Documents (Full-Text)
More Information
Publications
None provided.- 01