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

Sponsor
Sociedad Argentina de Reumatologia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04568421
Collaborator
(none)
3,000
1
16.4
182.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
Actual Study Start Date :
Aug 18, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [2 month]

      Death caused by SARS-CoV-2 infection

    2. Hospitalization [2 month]

      Hospitalization because of SARS-CoV-2 infection

    Secondary Outcome Measures

    1. SARS-CoV-2 infection presentation [1 month]

      To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases

    2. Admission at the intensive care unit [2 month]

      Proportion of patients admitted at the intensive care unit

    3. Invasive mechanical ventilation [2 month]

      Proportion of patients who required invasive mechanical ventilation

    4. COVID-19 Complications [2 month]

      Proportion of patients who had complications associated with COVID-19 infection and describe them

    5. Recovery rate [2 month]

      Proportion of patients fully or partially recovered after COVID-19 infection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sociedad Argentina de Reumatología Ciudad Autónoma de Buenos Aires Caba Argentina 1022

    Sponsors and Collaborators

    • Sociedad Argentina de Reumatologia

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sociedad Argentina de Reumatologia
    ClinicalTrials.gov Identifier:
    NCT04568421
    Other Study ID Numbers:
    • 01
    First Posted:
    Sep 29, 2020
    Last Update Posted:
    Sep 29, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Sociedad Argentina de Reumatologia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 29, 2020