JMIR Research Protocols (Dec 2020)

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

  • Marques, Claudia,
  • Kakehasi, Adriana Maria,
  • Gomides, Ana Paula Monteiro,
  • Paiva, Eduardo Dos Santos,
  • dos Reis Neto, Edgard Torres,
  • Pileggi, Gecilmara Cristina Salviato,
  • Provenza, José Roberto,
  • Mota, Licia,
  • Xavier, Ricardo Machado,
  • Ferreira, Gilda Aparecida,
  • Pinheiro, Marcelo Medeiros

DOI
https://doi.org/10.2196/24357
Journal volume & issue
Vol. 9, no. 12
p. e24357

Abstract

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BackgroundPatients 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. ObjectiveThis 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). MethodsThe 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). ResultsRecruitment 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. ConclusionsWe believe this study will provide clinically relevant data on the general impact of COVID-19 on patients with IMRD. Trial RegistrationBrazilian Registry of Clinical Trials RBR-33YTQC; http://www.ensaiosclinicos.gov.br/rg/RBR-33ytqc/ International Registered Report Identifier (IRRID)DERR1-10.2196/24357