SARS-CoV InfectionNCT04530461
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
An observational study of SARS-CoV Infection and Systemic Disease, run by faida agili at 1 site in Tunisia.
Trial summary
An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Systemic Disease, Systemic Lupus Erythematosus
- What is being tested?
- Serological test
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2020to 31 Jan 2021
- 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 one of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
Who may be able to join
- Age over 18 years old
- One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
- Informed consent obtained and signed
Who cannot join
- Refusal to repeat blood sampling if the first one was badly performed
- Informed consent not obained
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Military Hospital of Tunis
Tunis
Faida Ajili, MD, +21698631188, faida1977@yahoo.fr
Faida Ajili, MD
About this study
An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis
Read the detailed description
The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2.
Patients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.
- Conditions
- SARS-CoV Infection, Systemic Disease, Systemic Lupus Erythematosus, Sjogren's Syndrome, Sarcoidosis, Inflammatory Myopathy
- Being tested
- Serological test
- Medical subject headings
- Severe Acute Respiratory Syndrome, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Sarcoidosis, Myositis, Behcet Syndrome, Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological testDiagnostic test
Positive serological test of SARS Cov2
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological Profile
Number of patients with positive serological test of SARS Cov2
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Jun 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- faida agili
- Sponsor type
- University, hospital or other
- Collaborators
- UR17DN02 : Autoimmune Diseases Research Unit
- Responsible party
- Sponsor-investigator, faida agili, Military Hospital of Tunis
- Investigators
- Faida Ajili, MD, Study chair, Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530461
- Sponsor's protocol ID
- UR17DN02-002
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
- ClinicalTrials.gov ID
- NCT04530461
- Acronym / sponsor ID
- UR17DN02-002
- Conditions
- SARS-CoV Infection, Systemic Disease, Systemic Lupus Erythematosus, Sjogren's Syndrome, Sarcoidosis, Inflammatory Myopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- faida agiliUniversity, hospital or other
- Collaborators
- UR17DN02 : Autoimmune Diseases Research Unit
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 28 Aug 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.
An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis
Detailed description
The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2.
Patients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with one of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
Key inclusion criteria (3 listed)
- Age over 18 years old
- One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
- Informed consent obtained and signed
Key exclusion criteria (2 listed)
- Refusal to repeat blood sampling if the first one was badly performed
- Informed consent not obained
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 |
|---|---|---|
| Serological testPositive serological test of SARS Cov2 | Diagnostic test | – |
Primary outcome
Serological Profile
Time frame: Inclusion
Number of patients with positive serological test of SARS Cov2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- 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.
Faida Ajili, MD study chair
Military Hospital of Tunis
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 SARS-CoV Infection and Systemic Disease, run by faida agili at 1 site in Tunisia.
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 2 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 22 Sep 2020. 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 Tunisia. 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 Faida Ajili, MD (+21698631188, faida1977@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological Profile (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2020.