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NCT04345159 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

— COVCALL  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04345159
Other study ID # GDE_2020_11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2020
Est. completion date November 30, 2020

Study information
Verified date January 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 572
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire by phone call
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.

Locations
Country Name City State
France Fondation Adolphe de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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