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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.
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunosuppressive Agents | Drug | Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death caused by SARS-CoV-2 infection | 2 month |
| Hospitalization | Hospitalization because of SARS-CoV-2 infection | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 infection presentation | To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases | 1 month |
| Admission at the intensive care unit | Proportion of patients admitted at the intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with COVID-19 and some rheumatic disease, who are cared for by rheumatologists in any of the 23 provinces of Argentina
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Pons-Estel | Unidad de Investigación Sociedad Argentina ReumatologÃa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sociedad Argentina de ReumatologÃa | Buenos Aires | Buenos Aires F.D. | 1022 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36454054 | Derived | Isnardi CA, Soriano ER, Graf C, de la Vega MC, Pons-Estel BA, Roberts K, Quintana R, Gomez G, Yazdany J, Saurit V, Baez RM, Coello VVC, Pisoni CN, Berbotto G, Vivero F, Zelaya MD, Haye Salinas MJ, Reyes Torres AA, Ornella S, Nieto RE, Maldonado FN, Gamba MJ, Severina MLA, Tissera Y, Alba P, Cogo AK, Alle G, Gobbi C, Banos A, Velozo E, Pera M, Tanten R, Albiero JA, Maldonado Ficco H, Martire MV, Elkin MSG, Cosatti M, Cusa MA, Pereira D, Savio VG, Pons-Estel GJ. Does the Use of Immunosuppressive Drugs Impact on SARS-CoV-2 Infection Outcome? Data From A National Cohort of Patients With Immune-Mediated Inflammatory Diseases (SAR-COVID Registry). J Clin Rheumatol. 2023 Mar 1;29(2):68-77. doi: 10.1097/RHU.0000000000001903. Epub 2022 Nov 30. | |
| 36201124 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2020 | Sep 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011024 | Pneumonia, Viral |
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| ID | Term |
|---|---|
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| 2 month |
| Invasive mechanical ventilation | Proportion of patients who required invasive mechanical ventilation | 2 month |
| COVID-19 Complications | Proportion of patients who had complications associated with COVID-19 infection and describe them | 2 month |
| Recovery rate | Proportion of patients fully or partially recovered after COVID-19 infection. | 2 month |
| Derived |
| Isnardi CA, Roberts K, Saurit V, Petkovic I, Baez RM, Quintana R, Tissera Y, Ornella S, D Angelo Exeni ME, Pisoni CN, Castro Coello VV, Berbotto G, Haye Salinas MJ, Velozo E, Reyes Torres AA, Tanten R, Zelaya MD, Gobbi C, Alonso CG, de Los Angeles Severina M, Vivero F, Paula A, Cogo AK, Alle G, Pera M, Nieto RE, Cosatti M, Asnal C, Pereira D, Albiero JA, Savio VG, Maldonado FN, Gamba MJ, German NF, Banos A, Gallino Yanzi J, Galvez Elkin MS, Morbiducci JS, Martire MV, Maldonado Ficco H, Schmid MM, Villafane Torres JA, de Los Angeles Correa M, Medina MA, Cusa MA, Scafati J, Aguero SE, Lloves Schenone NM, Soriano ER, Graf C, Pons-Estel BA, Gomez G, Landi M, De la Vega MC, Pons-Estel GJ; S. A. R.-COVID Registry Investigators. Sociodemographic and clinical factors associated with poor COVID-19 outcomes in patients with rheumatic diseases: data from the SAR-COVID Registry. Clin Rheumatol. 2023 Feb;42(2):563-578. doi: 10.1007/s10067-022-06393-8. Epub 2022 Oct 6. |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |