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Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases

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: NCT04530461
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
UR17DN02 : Autoimmune Diseases Research Unit
Information provided by (Responsible Party):
faida agili, Military Hospital of Tunis

Study Description
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Brief 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

Condition or disease Intervention/treatment
SARS-CoV Infection Systemic Disease Systemic Lupus Erythematosus Sjogren's Syndrome Sarcoidosis Inflammatory Myopathy Behçet Disease Rheumatoid Arthritis Spondyloarthritis Diagnostic Test: Serological test

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
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Serological test
    Positive serological test of SARS Cov2

Outcome Measures
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Primary Outcome Measures :
  1. Serological Profile [ Time Frame: Inclusion ]
    Number of patients with positive serological test of SARS Cov2


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with one of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refusal to repeat blood sampling if the first one was badly performed
  • Informed consent not obained
Contacts and Locations
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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): NCT04530461


Contacts
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Contact: Faida Ajili, MD +21698631188 faida1977@yahoo.fr

Locations
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Tunisia
Military Hospital of Tunis Recruiting
Tunis, Tunisia
Contact: Faida Ajili, MD    +21698631188    faida1977@yahoo.fr   
Principal Investigator: Faida Ajili, MD         
Sub-Investigator: Sameh Sayahi, MD         
Sub-Investigator: Rim Dhahri, MD         
Sponsors and Collaborators
faida agili
UR17DN02 : Autoimmune Diseases Research Unit
Investigators
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Study Chair: Faida Ajili, MD Military Hospital of Tunis
More Information
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Responsible Party: faida agili, Director of Autoimmune Diseases Research Unit (UR17DN02) and Professor in internal medicine departement. Sponsor and Principal Investigator, Military Hospital of Tunis
ClinicalTrials.gov Identifier: NCT04530461    
Other Study ID Numbers: UR17DN02-002
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Sjogren's Syndrome
Myositis
Behcet Syndrome
Sarcoidosis
Lupus Erythematosus, Systemic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Lymphoproliferative Disorders
Lymphatic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Uveitis, Anterior
Panuveitis
Uveitis