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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Autoimmune Diseases
• Lupus Erythematosus, Systemic
• Psoriatic Arthritis
• Rheumatoid Arthritis
• SARS-CoV-2
• Sjogren's Syndrome
• Systemic Lupus Erythematosus

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