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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04345159|
Recruitment Status : Active, not recruiting
First Posted : April 14, 2020
Last Update Posted : May 13, 2020
|Condition or disease||Intervention/treatment|
|SARS-CoV-2 Systemic Lupus Erythematosus Rheumatoid Arthritis Sjogren's Syndrome Psoriatic Arthritis||Other: Questionnaire by phone call|
|Study Type :||Observational|
|Actual Enrollment :||572 participants|
|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|
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.
- 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.
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
|Fondation Adolphe de Rothschild|
|Paris, France, 75019|
|Principal Investigator:||Guillaume DEBELLEMANIERE, MD||Fondation Adolphe de Rothschild|