- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345159
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)
January 6, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
572
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75019
- Fondation Adolphe de Rothschild
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient with autoimmune disease
Selected using appropriate keywords in the Foundation Rothschild Hospital EMR, consenting to participate in the study.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 months after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guillaume DEBELLEMANIERE, MD, Fondation Adolphe de Rothschild
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2020
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
April 10, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
January 7, 2021
Last Update Submitted That Met QC Criteria
January 6, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Eye Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Lacrimal Apparatus Diseases
- Spondylarthropathies
- Spondylarthritis
- Spondylitis
- Psoriasis
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Arthritis
- Lupus Erythematosus, Systemic
- Arthritis, Psoriatic
- Autoimmune Diseases
- Sjogren's Syndrome
Other Study ID Numbers
- GDE_2020_11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Universidad Autonoma de Nuevo LeonCompletedRheumatoId ArthritisMexico
-
Hamad Medical CorporationUnknownRHEUMATOID ARTHRITISQatar
Clinical Trials on Questionnaire by phone call
-
University Hospital, ToulouseCompletedCOVID-19 | Physical ActivityFrance
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
M.D. Anderson Cancer CenterNational Institute of Dental and Craniofacial Research (NIDCR); American Cancer...Unknown
-
Baoshan Prefecture Center for Disease Control and...Prince of Songkla UniversityUnknownMedication AdherenceChina
-
University Hospital, ToursINSERM CIC-P 1415CompletedCardiovascular Diseases | Mental DisorderFrance
-
Hospices Civils de LyonCompletedAnaphylaxis | Allergic ReactionFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingMild Traumatic Brain InjuryFrance
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Laboratoires InnotheraFloralisRecruitingPost Thrombotic SyndromeFrance
-
Washington University School of MedicineThe Foundation for Barnes-Jewish Hospital; BJC Innovative LabTerminatedAbdominal SurgeryUnited States