COVCALL: 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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT04345159

Collaborator

(none)

572

Enrollment

Location

7.5

Actual Duration (Months)

76.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Systemic Lupus Erythematosus Rheumatoid Arthritis Sjogren's Syndrome Psoriatic Arthritis	Other: Questionnaire by phone call

Study Design

Study Type:

Observational

Actual Enrollment :

572 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Apr 17, 2020

Actual Primary Completion Date :

Nov 30, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: Guillaume DEBELLEMANIERE, MD, Fondation Adolphe de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04345159

Other Study ID Numbers:

GDE_2020_11

First Posted:

Apr 14, 2020

Last Update Posted:

Jan 7, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild

Hydroxychloroquine

Additional relevant MeSH terms:

Arthritis

Arthritis, Psoriatic

Sjogren's Syndrome

Lupus Erythematosus, Systemic

Autoimmune Diseases

Study Results

No Results Posted as of Jan 7, 2021