TY  - JOUR
AU  - Marques, Claudia
AU  - Kakehasi, Adriana Maria
AU  - Gomides, Ana Paula Monteiro
AU  - Paiva, Eduardo Dos Santos
AU  - dos Reis Neto, Edgard Torres
AU  - Pileggi, Gecilmara Cristina Salviato
AU  - Provenza, José Roberto
AU  - Mota, Licia
AU  - Xavier, Ricardo Machado
AU  - Ferreira, Gilda Aparecida
AU  - Pinheiro, Marcelo Medeiros
PY  - 2020
DA  - 2020/12/15
TI  - 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
JO  - JMIR Res Protoc
SP  - e24357
VL  - 9
IS  - 12
KW  - COVID-19
KW  - SARS-CoV-2
KW  - prospective study
KW  - immune-mediated rheumatic diseases
KW  - registry
KW  - Brazil
KW  - inflammatory
KW  - chronic disease
KW  - cohort
KW  - immunology
KW  - infection rate
KW  - mortality
KW  - morbidity
AB  - 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 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2020/12/e24357
UR  - https://doi.org/10.2196/24357
UR  - http://www.ncbi.nlm.nih.gov/pubmed/33156812
DO  - 10.2196/24357
ID  - info:doi/10.2196/24357
ER  -