Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

Completed

• Conditions: SARS-CoV-2; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Psoriatic Arthritis; Sjogren's Syndrome
• Interventions: Other: Questionnaire by phone call

• Registration Number: NCT04345159
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Study Start: 2020-04-17
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 572

Inclusion Criteria

• History of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome or Psoriatic Arthritis.

Exclusion Criteria

• beginning, or end, of an hydroxychloroquine treatment between Jan 1, 2020 and day of the phone call.
• Bad treatment compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with autoimmune disease	Questionnaire by phone call	Selected using appropriate keywords in the Foundation Rothschild Hospital EMR, consenting to participate in the study.

Primary Outcome Measures

Name	Time	Method
Adjusted Odds Ratio	4 months after inclusion	Adjusted Odds Ratio measuring the association between an exposure to long-term hydroxychloroquine intake and a history of symptoms compatible with a COVID-19 infection.

Trial Locations

Locations (1)

Fondation Adolphe de Rothschild; 🇫🇷 Paris, France