Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04434118
• Other study ID #: IRB: RC-5-2020
• Status: Withdrawn
• Start date: March 20, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2022
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.

Exclusion Criteria:

• The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.
• Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)
• Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• COVID
• Rheumatoid Arthritis

Intervention

Drug:
• Traditional antirheumatic drugs
Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Shibin Al Kawm

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The risk of COVID-19 infection among RA patients	Realtion between hydroxychloroquine use and COVID-19 infection	12 week
Secondary	The incidence of hospitalization for Covid-19 patients.	Number of cases and number of hospitalization days	12 week