Rheumatic DiseasesSAR-CoVACNCT04845997
COVID-19 Vaccination in Patients With Rheumatic Diseases
An observational study of Rheumatic Diseases, run by Sociedad Argentina de Reumatologia at 2 sites in Argentina.
Trial summary
The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 3,000 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Jul 2021to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country
Who may be able to join
- Patients ≥ 18 years of age.
- Diagnosis of rheumatic disease treated or not with immunosuppressive agents
- Patients who have received at least one dose of a SARS-CoV-2 vaccine
- Signature of informed consent.
Who cannot join
- Patients who express their desire not to participate in the study or who are unable to give their informed consent.
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites, 2 recruiting
- Recruiting
Sociedad Argentina de Reumatología
Buenos Aires, Buenos Aires F.D., 1022
Guillermo Posn-Estel, PhD, +5493412644125, unisar@reumatologia.org.ar
Carolina Isnardi, MD, +541169583394, carolina.isnardi@reumatologia.org.ar
- Recruiting
Sociedad Argentina de Reumatologia
Buenos Aires, 1022
Carolina Isnardi, MD, 1169583394, carolina.isnardi@reumatologia.org.ar
Guillermo Pons Estel, MD, unisar@reumatologia.org.ar
About this study
Official title: NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY
The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.
Read the detailed description
This is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country. Patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed.
The aim of this registry is to evaluate the efficacy and safety of the SARS-CoV-2 vaccines in patients with rheumatic diseases.
- Conditions
- Rheumatic Diseases
- Being tested
- COVID-19 Vaccine
- Keywords
- SARS-CoV-2, COVID-19 Vaccines
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Patients with rheumatic diseases who have been vaccinated for COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Vaccine efficacy
Number of patients who develop SARS-CoV-2 infection after vaccination
Measured: 12 month
COVID-19 Vaccine safety
Number of patients who develop adverse events asssociated with vaccination
Measured: 12 month
Secondary outcomes (4)
New immunomediated events
Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events.
Measured: 12 month
Flare
Number of patients who develop a flare asssociated with vaccination. Description
Measured: 12 months
Changes in the rheumatic disease treatment
Changes in the rheumatic disease treatment associated with vaccination, and study its influence on the efficacy (number of patients who develop SARS-CoV-2 infection after vaccination) and safety (number of patients who develop adverse events asssociated with vaccination) of the vaccine for SARS-CoV-2.
Measured: 12 months
Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases
Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 3,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sociedad Argentina de Reumatologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Isnardi, MD, Principal investigator, Unidad de Investigación Sociedad Argentina Reumatología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845997
- Sponsor's protocol ID
- 02
- Acronym
- SAR-CoVAC
- Status last verified
- Jan 2023
- First submitted
- 12 Apr 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isnardi CA, Schneeberger EE, Kreimer JL, Luna PC, Echeverria C, Roberts K, de la Vega MC, Virasoro BM, Landi M, Quintana R, Exeni MED, Kogan N, Petkovic I, Pereira D, De Los Angeles Correa M, Zelaya MD, Tissera Y, Elkin MSG, Pisoni CN, Alonso C, Cogo AK, Cosatti MA, Garcia L, Retamozo C, de Los Angeles Severina M, Nieto RE, Rosemffet M, Mussano E, Bertoli A, Savio VG, Cosentino V, Pons-Estel GJ. An Argentinean cohort of patients with rheumatic and immune-mediated diseases vaccinated for SARS-CoV-2: the SAR-CoVAC Registry-protocol and preliminary data. Clin Rheumatol. 2022 Oct;41(10):3199-3209. doi: 10.1007/s10067-022-06253-5. Epub 2022 Jun 28.
PubMed 35760939
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
- NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY
- ClinicalTrials.gov ID
- NCT04845997
- Acronym / sponsor ID
- SAR-CoVAC / 02
- Conditions
- Rheumatic Diseases
- Keywords
- SARS-CoV-2, COVID-19 Vaccines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sociedad Argentina de ReumatologiaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Apr 2021 (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.
The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.
Detailed description
This is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country. Patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed.
The aim of this registry is to evaluate the efficacy and safety of the SARS-CoV-2 vaccines in patients with rheumatic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age.
- Diagnosis of rheumatic disease treated or not with immunosuppressive agents
- Patients who have received at least one dose of a SARS-CoV-2 vaccine
- Signature of informed consent.
Key exclusion criteria (1 listed)
- Patients who express their desire not to participate in the study or who are unable to give their 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 |
|---|---|---|
| COVID-19 VaccinePatients with rheumatic diseases who have been vaccinated for COVID-19 | Biological | – |
Primary outcome
COVID-19 Vaccine efficacy
Time frame: 12 month
Number of patients who develop SARS-CoV-2 infection after vaccination
COVID-19 Vaccine safety
Time frame: 12 month
Number of patients who develop adverse events asssociated with vaccination
4 secondary outcomes
New immunomediated events
Time frame: 12 month
Flare
Time frame: 12 months
Changes in the rheumatic disease treatment
Time frame: 12 months
Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 35760939Isnardi CA, Schneeberger EE, Kreimer JL, Luna PC, Echeverria C, Roberts K, de la Vega MC, Virasoro BM, Landi M, Quintana R, Exeni MED, Kogan N, Petkovic I, Pereira D, De Los Angeles Correa M, Zelaya MD, Tissera Y, Elkin MSG, Pisoni CN, Alonso C, Cogo AK, Cosatti MA, Garcia L, Retamozo C, de Los Angeles Severina M, Nieto RE, Rosemffet M, Mussano E, Bertoli A, Savio VG, Cosentino V, Pons-Estel GJ. An Argentinean cohort of patients with rheumatic and immune-mediated diseases vaccinated for SARS-CoV-2: the SAR-CoVAC Registry-protocol and preliminary data. Clin Rheumatol. 2022 Oct;41(10):3199-3209. doi: 10.1007/s10067-022-06253-5. Epub 2022 Jun 28.
- 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.
Carolina Isnardi, MD principal investigator
Unidad de Investigación Sociedad Argentina Reumatología
2 sites 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 2 sites 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 4 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: status not confirmed, 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Isnardi, MD (+5491169583394, carolina.isnardi@reumatologia.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Vaccine efficacy (time frame: 12 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 NCT04845997, which also lists 1 linked publication.
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.