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

NCT ID: NCT04530461

Last Updated: 2020-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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

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SARS-CoV Infection Systemic Disease Systemic Lupus Erythematosus Sjogren's Syndrome Sarcoidosis Inflammatory Myopathy Behçet Disease Rheumatoid Arthritis Spondyloarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Serological test

Positive serological test of SARS Cov2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UR17DN02 : Autoimmune Diseases Research Unit

UNKNOWN

Sponsor Role collaborator

faida agili

OTHER

Sponsor Role lead

Responsible Party

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faida agili

Director of Autoimmune Diseases Research Unit (UR17DN02) and Professor in internal medicine departement. Sponsor and Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Faida Ajili, MD

Role: STUDY_CHAIR

Military Hospital of Tunis

Locations

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Military Hospital of Tunis

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Faida Ajili, MD

Role: CONTACT

+21698631188

Facility Contacts

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Faida Ajili, MD

Role: primary

+21698631188

Other Identifiers

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UR17DN02-002

Identifier Type: -

Identifier Source: org_study_id

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