%0 Journal Article
%@ 1929-0748
%I JMIR Publications
%V 9
%N 12
%P e24357
%T A Brazilian Cohort of Patients With Immuno-Mediated Chronic Inflammatory Diseases Infected by SARS-CoV-2 (ReumaCoV-Brasil Registry): Protocol for a Prospective, Observational Study
%A Marques,Claudia
%A Kakehasi,Adriana Maria
%A Gomides,Ana Paula Monteiro
%A Paiva,Eduardo Dos Santos
%A dos Reis Neto,Edgard Torres
%A Pileggi,Gecilmara Cristina Salviato
%A Provenza,José Roberto
%A Mota,Licia
%A Xavier,Ricardo Machado
%A Ferreira,Gilda Aparecida
%A Pinheiro,Marcelo Medeiros
%+ Hospital das Clínicas, Universidade Federal de Minas Gerais, Av Prof Alfredo Balena, 110 - Santa Efigênia, Belo Horizonte, 30130-100, Brazil, 55 31 996174211, gildaferreira9@gmail.com
%K COVID-19
%K SARS-CoV-2
%K prospective study
%K immune-mediated rheumatic diseases
%K registry
%K Brazil
%K inflammatory
%K chronic disease
%K cohort
%K immunology
%K infection rate
%K mortality
%K morbidity
%D 2020
%7 15.12.2020
%9 Protocol
%J JMIR Res Protoc
%G English
%X 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 raised regarding the impact of COVID-19 at the start of the pandemic. Objective: This paper presents the protocol of a study that aims to prospectively evaluate patients with IMRD and a confirmed COVID-19 diagnosis (using criteria provided by the Brazilian Ministry of Health). Methods: The study comprised a prospective, observational cohort (patients with IMRD and COVID-19) and a comparison group (patients with only IMRD), with a follow-up time of 6 months to evaluate differences in health outcomes. The primary outcomes will be changes in IMRD disease activity after SARS-CoV-2 infection at 4 time points: (1) at baseline, (2) within 4-6 weeks after infection, (3) at 3 months after the second assessment (±15 days), and (4) at 6 months (±15 days). The secondary outcomes will be the progression rate to moderate or severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death, and therapeutic changes related to IMRD. Two outcomes—pulmonary and thromboembolic events in patients with both IMRD and SARS-CoV-2 infection—are of particular interest and will be monitored with close attention (clinical, laboratory, and function tests as well as imaging). Results: Recruitment opened in May 2020, with 1300 participants recruited from 43 sites as of November 2020. Patient recruitment will conclude by the end of December 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 paper in December 2020. Conclusions: We believe this study will provide clinically relevant data on the general impact of COVID-19 on patients with IMRD. Trial Registration: Brazilian Registry of Clinical Trials RBR-33YTQC; http://www.ensaiosclinicos.gov.br/rg/RBR-33ytqc/ International Registered Report Identifier (IRRID): DERR1-10.2196/24357 
%M 33156812
%R 10.2196/24357
%U https://www.researchprotocols.org/2020/12/e24357
%U https://doi.org/10.2196/24357
%U http://www.ncbi.nlm.nih.gov/pubmed/33156812