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

Rheumatic Diseases Clinical Trial

— SAR-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568421
• Other study ID #: 01
• Status: Completed
• Start date: August 18, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Sociedad Argentina de Reumatologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2982
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Rheumatic Diseases

Intervention

Drug:
• Immunosuppressive Agents
Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician

Locations

Country	Name	City	State
Argentina	Sociedad Argentina de Reumatología	Ciudad Autónoma de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Argentina de Reumatologia

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death caused by SARS-CoV-2 infection	2 month
Primary	Hospitalization	Hospitalization because of SARS-CoV-2 infection	2 month
Secondary	SARS-CoV-2 infection presentation	To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases	1 month
Secondary	Admission at the intensive care unit	Proportion of patients admitted at the intensive care unit	2 month
Secondary	Invasive mechanical ventilation	Proportion of patients who required invasive mechanical ventilation	2 month
Secondary	COVID-19 Complications	Proportion of patients who had complications associated with COVID-19 infection and describe them	2 month
Secondary	Recovery rate	Proportion of patients fully or partially recovered after COVID-19 infection.	2 month