Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
Condition: Rheumatic Diseases
MeSH terms: COVID-19; Rheumatic Diseases; Collagen Diseases
Study type: Observational [Patient Registry]

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.
    

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

        -  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.
    

Intervention name(s): Immunosuppressive Agents
Intervention type(s): Drug
Intervention description(s): Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician
Other intervention name(s): Immunomodulatory and/or immunosuppressive treatments
Intervention MeSH terms: Immunosuppressive Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with COVID-19 and some rheumatic disease, who are cared for by rheumatologists in
        any of the 23 provinces of Argentina
      
Keywords: COVID-19