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

NCT04345159 | Completed

• 1 other identifier: GDE_2020_11
• Study Type: observational
• Target: 572
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Sjogren's Syndrome; Psoriatic Arthritis

Keywords

Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• Adjusted Odds Ratio

  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.

  4 months after inclusion

Study Arms (1)

Patient with autoimmune disease

Selected using appropriate keywords in the Foundation Rothschild Hospital EMR, consenting to participate in the study.

Other: Questionnaire by phone call

Interventions

Questionnaire by phone call OTHER

2 questionnaires : at inclusion and 4 months later. The exposure to hydroxychloroquine and the history of autoimmune disease is determined during the phone call along with other exposure factors. The symptoms presented by the patient are classified in "Suggestive of a COVID-19 infection" or "Not suggestive of COVID-19 infection" by a team of internists and infectious diseases specialists, by studying the questionnaires after the completion in a blind-manner regarding the hydroxychloroquine intake.

Patient with autoimmune disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at least one time at Rothschild Foundation with history of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome, Psoriatic Arthritis.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Guillaume D, Magalie B, Sina E, Imene SM, Frederic V, Mathieu D, Aurore M, Yoni G, Emma E, Charlotte B, Laura F, Alain S, Steven N, Pierre Z, Jean-Luc F, Romain C, Alice GD, Adrien M, Wassim G, Pierre-Emmanuel R, Christophe P, Catherine C, Kevin B, Thomas S, Damien G. Antirheumatic Drug Intake Influence on Occurrence of COVID-19 Infection in Ambulatory Patients with Immune-Mediated Inflammatory Diseases: A Cohort Study. Rheumatol Ther. 2021 Dec;8(4):1887-1895. doi: 10.1007/s40744-021-00373-1. Epub 2021 Sep 16.

  PMID: 34529226 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid; Sjogren's Syndrome; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Guillaume DEBELLEMANIERE, MD

  Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: April 17, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

FR (1)