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).