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

• Sponsor: Sadat City University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04434118
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 21.4
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; COVID	Drug: Traditional antirheumatic drugs

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study
• Actual Study Start Date: Mar 20, 2020
• Actual Primary Completion Date: Dec 30, 2021
• Anticipated Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Rheumatoid Arthritis with COVID-19	Drug: Traditional antirheumatic drugs; Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine
Rheumatoid Arthritis without COVID-19	Drug: Traditional antirheumatic drugs; Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine

Outcome Measures

Primary Outcome Measures

1. The risk of COVID-19 infection among RA patients [12 week]

   Realtion between hydroxychloroquine use and COVID-19 infection

Secondary Outcome Measures

1. The incidence of hospitalization for Covid-19 patients. [12 week]

   Number of cases and number of hospitalization days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Shibīn Al Kawm		Egypt

Sponsors and Collaborators

• Sadat City University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Samy Abdallah, Lecturer of Clinical Pharmacy, PhD., Sadat City University
• ClinicalTrials.gov Identifier: NCT04434118
• Other Study ID Numbers: IRB: RC-5-2020
• First Posted: Jun 16, 2020
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents

Study Results

No Results Posted as of May 9, 2022