Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568421
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Rheumatic Diseases 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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 Name: 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.



Primary Outcome Measures :
  1. Mortality [ Time Frame: 2 month ]
    Death caused by SARS-CoV-2 infection

  2. Hospitalization [ Time Frame: 2 month ]
    Hospitalization because of SARS-CoV-2 infection


Secondary Outcome Measures :
  1. SARS-CoV-2 infection presentation [ Time Frame: 1 month ]
    To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases

  2. Admission at the intensive care unit [ Time Frame: 2 month ]
    Proportion of patients admitted at the intensive care unit

  3. Invasive mechanical ventilation [ Time Frame: 2 month ]
    Proportion of patients who required invasive mechanical ventilation

  4. COVID-19 Complications [ Time Frame: 2 month ]
    Proportion of patients who had complications associated with COVID-19 infection and describe them

  5. Recovery rate [ Time Frame: 2 month ]
    Proportion of patients fully or partially recovered after COVID-19 infection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568421


Contacts
Layout table for location contacts
Contact: Guillermo Pons-Estel, PhD +5493412644125 unisar@reumatologia.org.ar
Contact: Carolina Isnardi, MD +5491169583394 carolina.isnardi@reumatologia.org.ar

Locations
Layout table for location information
Argentina
Sociedad Argentina de Reumatología Recruiting
Ciudad Autónoma de Buenos Aires, Caba, Argentina, 1022
Contact: Guillermo Posn-Estel, PhD    +5493412644125    unisar@reumatologia.org.ar   
Contact: Carolina Isnardi, MD    +541169583394    carolina.isnardi@reumatologia.org.ar   
Sponsors and Collaborators
Sociedad Argentina de Reumatologia
Investigators
Layout table for investigator information
Study Director: Guillermo Pons-Estel Unidad de Investigación Sociedad Argentina Reumatología
  Study Documents (Full-Text)

Documents provided by Sociedad Argentina de Reumatologia:
Layout table for additonal information
Responsible Party: Sociedad Argentina de Reumatologia
ClinicalTrials.gov Identifier: NCT04568421    
Other Study ID Numbers: 01
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sociedad Argentina de Reumatologia:
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs