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

NCT04568421 | Completed

• 1 other identifier: 01
• Study Type: observational
• Target: 2,982
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Diseases

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• Mortality

  Death caused by SARS-CoV-2 infection

  2 month

• Hospitalization

  Hospitalization because of SARS-CoV-2 infection

  2 month

Secondary Outcomes (5)

• SARS-CoV-2 infection presentation

  1 month

• Admission at the intensive care unit

  2 month

• Invasive mechanical ventilation

  2 month

• COVID-19 Complications

  2 month

• Recovery rate

  2 month

Study Arms (2)

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

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.

Interventions

Immunosuppressive Agents DRUG

Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician

Also known as: Immunomodulatory and/or immunosuppressive treatments

Treated with immunomodulatory and/or -suppressive drugs

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not wish to participate or are unable to give informed consent.

Sponsors & Collaborators

• Sociedad Argentina de Reumatologia: lead

Study Sites (1)

Sociedad Argentina de Reumatología

Buenos Aires, Buenos Aires F.D., 1022, Argentina

Location

Related Publications (2)

• Isnardi CA, Soriano ER, Graf C, de la Vega MC, Pons-Estel BA, Roberts K, Quintana R, Gomez G, Yazdany J, Saurit V, Baez RM, Coello VVC, Pisoni CN, Berbotto G, Vivero F, Zelaya MD, Haye Salinas MJ, Reyes Torres AA, Ornella S, Nieto RE, Maldonado FN, Gamba MJ, Severina MLA, Tissera Y, Alba P, Cogo AK, Alle G, Gobbi C, Banos A, Velozo E, Pera M, Tanten R, Albiero JA, Maldonado Ficco H, Martire MV, Elkin MSG, Cosatti M, Cusa MA, Pereira D, Savio VG, Pons-Estel GJ. Does the Use of Immunosuppressive Drugs Impact on SARS-CoV-2 Infection Outcome? Data From A National Cohort of Patients With Immune-Mediated Inflammatory Diseases (SAR-COVID Registry). J Clin Rheumatol. 2023 Mar 1;29(2):68-77. doi: 10.1097/RHU.0000000000001903. Epub 2022 Nov 30.

  PMID: 36454054 DERIVED

• 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.

  PMID: 36201124 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases; COVID-19

Interventions

Immunosuppressive Agents

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Guillermo Pons-Estel

  Unidad de Investigación Sociedad Argentina Reumatología

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: August 18, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)