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

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

• Registration Number: NCT04530461
• Lead Sponsor: faida agili

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

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 Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-19
• Last Update Posted: 2020-09-22
• Primary Completion: 2020-11-30
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serological Profile	Inclusion	Number of patients with positive serological test of SARS Cov2

Trial Locations

Locations (1)

Military Hospital of Tunis; 🇹🇳 Tunis, Tunisia