Clinical trial NCT04568421: Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
Official title: Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
Keywords: COVID-19
Lead sponsor: Sociedad Argentina de Reumatologia
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 2982
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 2 month
measure: Hospitalization
timeFrame: 2 month
Secondary outcomes:
measure: SARS-CoV-2 infection presentation
timeFrame: 1 month
measure: Admission at the intensive care unit
timeFrame: 2 month
measure: Invasive mechanical ventilation
timeFrame: 2 month
measure: COVID-19 Complications
timeFrame: 2 month
measure: Recovery rate
timeFrame: 2 month
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Sociedad Argentina de Reumatología
state: Caba
Study officials:
affiliation: Unidad de Investigación Sociedad Argentina Reumatología
name: Guillermo Pons-Estel
role: STUDY_DIRECTOR
References:
citation: 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.