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

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.

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Key information

Conditions

SARS-CoV-2 Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mouth Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Salivary Gland Diseases Sjogren's Syndrome Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Stomatognathic Diseases Systemic Lupus Erythematosus Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Adjusted Odds Ratio

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: COVCALL

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 14, 2020
Registry last updated: Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed