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.

BACKGROUND: 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. OBJECTIVE: 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 (RD) and household individuals not diagnosed with RD and not taking antimalarials. METHODS: This is a 24-week 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 the 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 in 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. RESULTS: The recruitment have begun in the end of March, 2020 and the inclusion was done during a 8-week period (from March 29th to May 17st) with a total of 10,443 individuals enrolled at baseline, of whom 5,166 RD patients, from 23 tertiary rheumatology centers, including 97 Brazilian cities. Data analysis is scheduled to start after all inclusion data have been collected. CONCLUSIONS: 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). CLINICALTRIAL: Brazilian Registry of Clinical Trials (ReBEC; number RBR - 9KTWX6).