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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Drug: Immunosuppressive Agents

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.

• Study Type: Observational
• Enrollment (Actual): 2982

Contacts and Locations

Study Locations

• Argentina
  • Caba
    • Ciudad Autónoma de Buenos Aires, Caba, Argentina, 1022
      • Sociedad Argentina de Reumatología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Immunosuppressive Agents; Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician; Other Names: Immunomodulatory and/or immunosuppressive treatments
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sociedad Argentina de Reumatologia
• Investigators: Study Director: Guillermo Pons-Estel, Unidad de Investigación Sociedad Argentina Reumatología

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; COVID-19; Rheumatic Diseases; Collagen Diseases; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO