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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530461
• Other study ID #: UR17DN02-002
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2020
• Source: Military Hospital of Tunis
• Contact: Faida Ajili, MD
• Phone: +21698631188
• Email: faida1977[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behçet Disease
• Behcet Syndrome
• Coronavirus Infections
• Inflammatory Myopathy
• Lupus Erythematosus, Systemic
• Myositis
• Rheumatoid Arthritis
• Sarcoidosis
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Sjogren's Syndrome
• Spondyloarthritis
• Systemic Disease
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• Serological test
Positive serological test of SARS Cov2

Locations

Country	Name	City	State
Tunisia	Military Hospital of Tunis	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
faida agili	UR17DN02 : Autoimmune Diseases Research Unit

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serological Profile	Number of patients with positive serological test of SARS Cov2	Inclusion