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?:abstract
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BACKGROUND: Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, several questions were released regarding the impact of COVID-19 in the beginning of the pandemic OBJECTIVE: To evaluate prospectively patients with IMRD and a confirmed COVID-19 diagnosis, according to the Brazilian Ministry of Health criteria METHODS: Prospective, observational cohort, with a comparison group, with a follow-up time of 6 months The primary outcomes will be the IMRD disease activity changes after COVID-19, at four time points: (1) At baseline;(2) Within 4-6 weeks after infection by SARS-CoV-2;(3) 3 months after the second assessment (±15 days);(4) 6 months after (±15 days) The secondary outcomes will be the progression rate to moderate-severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death and therapeutic changes related to the IMRD Two outcomes are of particular interest considering the COVID-19 in IMRD patients, namely pulmonary and the thromboembolic events, and they will be monitored with more attention and details (clinical, lab, function tests and imaging) RESULTS: Recruitment opened in May, 2020, with 1000 participants recruited and 43 sites opened as of september 2020 Patient recruitment will be closed on October, 2020, with follow-up occurring until April, 2021 Data analysis is scheduled to start after all inclusion data have been collected, with an aim to publish a peer-reviewed article in October, 2020 CONCLUSIONS: We believe this study will provide many clinically relevant data on the general impact of COVID-19 on IMRD patients CLINICALTRIAL: This protocol was approved by the Brazilian Committee of Ethics in Human Research (CONEP) in April 5th, 2020 (CAAE 30186820 2 1001 8807;Number: 3 933 204) and registered on the Brazilian Registry of Clinical Trials - REBEC (RBR-33YTQC) in June, 1st 2020
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