Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 14, 2020
Date Accepted: Sep 8, 2020
Date Submitted to PubMed: Sep 14, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
IMPACT OF CHRONIC USE OF ANTIMALARIALS ON SARS-CoV-2 INFECTION IN PATIENTS WITH IMMUNE-MEDIATED RHEUMATIC DISEASES: PROTOCOL DESIGN FOR A MULTICENTRIC OBSERVATIONAL COHORT IN BRAZIL
ABSTRACT
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has brought enormous challenges to the scientific community in recent months and several studies have been developed in an attempt to minimize the impact of the disease worldwide. Although new knowledge has been quickly disseminated, including viral mechanisms, pathophysiology, and clinical findings, there is a lack of information about effective pharmacological management of this disease. In vitro studies showed some benefit of antimalarials (Chloroquine and Hydroxychloroquine) on inhibiting SARS-CoV-2. However, the data from open clinical trials are controversial in COVID-19 patients. This research project was developed to compare a potential protective effect to prevent moderate-severe forms of COVID-19 between patients treated chronically with antimalarials for rheumatic diseases and household individuals not diagnosed with IMRD and not taking antimalarials.This prospective observational cohort study includes patients from public and private health services across Brazil who chronically use antimalarials for the treatment of immune-mediated rheumatic diseases (IMRD), osteoarthritis, or chikungunya-related arthropathy. A total of six sequential phone visits were scheduled during 24-weeks of community viral transmission in five different regions of Brazil. All information regarding social, epidemiological, and demographic data, as well as details about rheumatic diseases, antimalarials, comorbidities, and concomitant medication is being recorded on a specific online form on the REDCap database. The symptoms suggestive of COVID-19, including fever, cough, dyspnea, anosmia, and dysgeusia, are being self-reported and collected by phone interviews. Our main outcomes are hospitalization, need of intensive care unit, and death. Trial registration: The project, which is currently in the data collection phase, was approved by the Brazilian Committee of Ethics in Human Research – CONEP (CAAE 30246120.3.1001.5505) and registered at the Brazilian Registry of Clinical Trials (ReBEC; number RBR- 9KTWX6)
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.