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

NCT04434118 | Withdrawn

• 1 other identifier: IRB: RC-5-2020
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; COVID

Outcome Measures

Primary Outcomes (1)

• The risk of COVID-19 infection among RA patients

  Realtion between hydroxychloroquine use and COVID-19 infection

  12 week

Secondary Outcomes (1)

• The incidence of hospitalization for Covid-19 patients.

  12 week

Study Arms (2)

Rheumatoid Arthritis with COVID-19

Drug: Traditional antirheumatic drugs

Rheumatoid Arthritis without COVID-19

Drug: Traditional antirheumatic drugs

Interventions

Traditional antirheumatic drugs DRUG

Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine

Rheumatoid Arthritis with COVID-19; Rheumatoid Arthritis without COVID-19

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients fulfilling 2010 ACR-EULAR classification criteria for RA

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Medicine

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy, PhD.

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 16, 2020
• Study Start: March 20, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)