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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 (COVCALL)

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ClinicalTrials.gov Identifier: NCT04345159
Recruitment Status : Active, not recruiting
First Posted : April 14, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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
SARS-CoV-2 Systemic Lupus Erythematosus Rheumatoid Arthritis Sjogren's Syndrome Psoriatic Arthritis Other: Questionnaire by phone call

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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 : April 17, 2020
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 2020


Group/Cohort 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345159


Locations
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France
Fondation Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Guillaume DEBELLEMANIERE, MD Fondation Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04345159    
Other Study ID Numbers: GDE_2020_11
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Hydroxychloroquine
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Sjogren's Syndrome
Lupus Erythematosus, Systemic
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases