Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
- Conditions
- Rheumatic Diseases
- Interventions
- Drug: Immunosuppressive Agents
- Registration Number
- NCT04568421
- Lead Sponsor
- Sociedad Argentina de Reumatologia
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2982
- 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.
- Patients who do not wish to participate or are unable to give informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treated with immunomodulatory and/or -suppressive drugs Immunosuppressive Agents 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.
- Primary Outcome Measures
Name Time Method Hospitalization 2 month Hospitalization because of SARS-CoV-2 infection
Mortality 2 month Death caused by SARS-CoV-2 infection
- Secondary Outcome Measures
Name Time Method Admission at the intensive care unit 2 month Proportion of patients admitted at the intensive care unit
Recovery rate 2 month Proportion of patients fully or partially recovered after COVID-19 infection.
Invasive mechanical ventilation 2 month Proportion of patients who required invasive mechanical ventilation
SARS-CoV-2 infection presentation 1 month To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases
COVID-19 Complications 2 month Proportion of patients who had complications associated with COVID-19 infection and describe them
Trial Locations
- Locations (1)
Sociedad Argentina de Reumatología
🇦🇷Ciudad Autónoma de Buenos Aires, Caba, Argentina