Rheumatic DiseasesSAR-COVIDNCT04568421
Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
An observational study of Rheumatic Diseases, run by Sociedad Argentina de Reumatologia at 1 site in Argentina.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Immunosuppressive Agents
- How many people
- 2,982 participants
- Where
- 1 siteArgentina
- Study dates
- 18 Aug 2020to 31 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COVID-19 and some rheumatic disease, who are cared for by rheumatologists in any of the 23 provinces of Argentina
Who may be able to join
- 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.
Who cannot join
- Patients who do not wish to participate or are unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Sociedad Argentina de Reumatología
Buenos Aires, Buenos Aires F.D., 1022
About this study
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.
Read the 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.
- Conditions
- Rheumatic Diseases
- Being tested
- Immunosuppressive Agents
- Keywords
- COVID-19
- Medical subject headings
- Rheumatic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppressive AgentsDrug
Also called Immunomodulatory and/or immunosuppressive treatments
Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death caused by SARS-CoV-2 infection
Measured: 2 month
Hospitalization
Hospitalization because of SARS-CoV-2 infection
Measured: 2 month
Secondary outcomes (5)
SARS-CoV-2 infection presentation
To describe clinical presentation of SARS-CoV-2 infection in patients with rheumatic diseases
Measured: 1 month
Admission at the intensive care unit
Proportion of patients admitted at the intensive care unit
Measured: 2 month
Invasive mechanical ventilation
Proportion of patients who required invasive mechanical ventilation
Measured: 2 month
COVID-19 Complications
Proportion of patients who had complications associated with COVID-19 infection and describe them
Measured: 2 month
Recovery rate
Proportion of patients fully or partially recovered after COVID-19 infection.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start18 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,982 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sociedad Argentina de Reumatologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillermo Pons-Estel, Study director, Unidad de Investigación Sociedad Argentina Reumatología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568421
- Sponsor's protocol ID
- 01
- Acronym
- SAR-COVID
- Status last verified
- Jan 2023
- First submitted
- 23 Sep 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36454054Isnardi 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.
PubMed 36201124
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argentinian Registry of Patients With Rheumatic Diseases and COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04568421
- Acronym / sponsor ID
- SAR-COVID / 01
- Conditions
- Rheumatic Diseases
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,982 participants (actual)
- Lead sponsor
- Sociedad Argentina de ReumatologiaUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with immunomodulatory and/or -suppressive drugs | – | Drug: Immunosuppressive AgentsPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 and some rheumatic disease, who are cared for by rheumatologists in any of the 23 provinces of Argentina
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not wish to participate or are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunosuppressive AgentsAlso: Immunomodulatory and/or immunosuppressive treatmentsImmunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician | Drug | Treated with immunomodulatory and/or -suppressive drugs |
Primary outcome
Mortality
Time frame: 2 month
Death caused by SARS-CoV-2 infection
Hospitalization
Time frame: 2 month
Hospitalization because of SARS-CoV-2 infection
5 secondary outcomes
SARS-CoV-2 infection presentation
Time frame: 1 month
Admission at the intensive care unit
Time frame: 2 month
Invasive mechanical ventilation
Time frame: 2 month
COVID-19 Complications
Time frame: 2 month
Recovery rate
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 36454054Isnardi 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.
- Derived from this study: PubMed 36201124Isnardi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Pons-Estel study director
Unidad de Investigación Sociedad Argentina Reumatología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Sociedad Argentina de Reumatologia at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568421, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.