Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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). 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 Age > 18 years. Patients with diagnosis of rheumatic diseases (treated or not with immunomodulatory and/or immunosuppressive drugs). 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: 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. 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.

Official Title
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Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection

Conditions
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Rheumatic Diseases

Intervention / Treatment
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* Drug: Immunosuppressive Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal or older than 18 years. Patients with diagnosis of rheumatic diseases (treated or not with immunomodulatory and/or immunosuppressive drugs). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with immunomodulatory and/or -suppressive drugs<br>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<br>* Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician<br>* Other names: Immunomodulatory and/or immunosuppressive treatments;|
| Not treated with immunomodulatory and/or -suppressive drugs<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death caused by SARS-CoV-2 infection | 2 month | 
| Hospitalization | Hospitalization because of SARS-CoV-2 infection | 2 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19