ReumaCoV Brasil Registry: Brazilian Study of Patients with Immuno-mediated Chronic Inflammatory Diseases Infected by SARS-CoV-2 

Abstract

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, a huge number of questions were released regarding the impact of COVID-19 in the beginning of the pandemic. Seeking to better understand this complex interaction, this study was developed to evaluate prospectively patients with IMRD and a suspected or confirmed COVID-19 diagnosis, according to the Ministry of Health of Brazil’s definitions. The primary outcomes will be the IMRD disease activity changes after COVID-19, at four time points: (1) At baseline and prior 6 months; (2) The first rheumatic evaluation after known infection by SARS-CoV-2 (4-6 weeks); (3) 3 months after the inclusion (±15 days); (4) 6 months after inclusion (±15 days). The secondary outcomes will be the progression rate to 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). This protocol was approved by the Brazilian Committee of Ethics in Human Research (CONEP) on 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. We believe this study will provide many clinically relevant data on the general impact of COVID-19 on IMRD patients.

High levels of immunosuppression are related to unfavourable outcomes in hospitalised patients with rheumatic diseases and COVID-19: first results of ReumaCoV Brasil registry

“…The complete study methodology was previously published. 7 Briefly, the ReumaCoV Brasil is a multicentre, observational, prospective cohort study carried out to monitor adult IMRD patients with COVID-19 diagnosis, using a convenience sample, whose data collection began 20 May 2020, with inclusion scheduled until December 2020, with 43 participating research centres. 8 This paper will present the analysis of data for the first 8 weeks of inclusion in the study.…”

Covid-19

“…Considerando individualmente os GCs, eles também podem ser iniciados, como em um tratamento padrão antes da pandemia. No entanto, doses diárias acima de 10 mg se associaram com pior desfecho da infecção pelo SARS-CoV-2 e esse panorama deve ser contemplado na individualização de cada caso 30,64,65 . Algumas peculiaridades sobre as DRIM e medicações precisam ser ponderadas individualmente, embora em algumas delas ainda não se tenha as respostas definitivas 25,[66][67][68] , como as listadas no Quadro 2.…”

“…Para pacientes que irão iniciar a medicação, a decisão compartilhada e individualizada, de acordo com o cenário de cada caso [76][77][78][79][80][81] . No entanto, vale a pena ressaltar que a terapia anti-tNF tem sido significativamente associada com menor taxa de internação pela coVid-19 30,31,65,82 .…”

Manejo clínico de pacientes com doenças reumáticas imunomediadas durante a pandemia da COVID-19

“…Considerando individualmente os GCs, eles também podem ser iniciados, como em um tratamento padrão antes da pandemia. No entanto, doses diárias acima de 10 mg se associaram com pior desfecho da infecção pelo SARS-CoV-2 e esse panorama deve ser contemplado na individualização de cada caso 30,64,65 . Algumas peculiaridades sobre as DRIM e medicações precisam ser ponderadas individualmente, embora em algumas delas ainda não se tenha as respostas definitivas 25,[66][67][68] , como as listadas no Quadro 2.…”

“…Sim, essa estratégia pode ser feita, desde que os preceitos e ponderações acima listados sejam cumpridos, incluindo doença em remissão e baixo risco de reativação, e a decisão compartilhada com o paciente. No entanto, vale a pena ressaltar que a terapia anti-TNF tem sido significativamente associada com menor taxa de internação pela COVID-19 30,31,65,82 .…”