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. 2020 Dec 15;9(12):e24357.
doi: 10.2196/24357.

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

Claudia Marques #  1 , Adriana Maria Kakehasi #  2 , Ana Paula Monteiro Gomides #  3 , Eduardo Dos Santos Paiva #  4 , Edgard Torres Dos Reis Neto #  5 , Gecilmara Cristina Salviato Pileggi #  6 , José Roberto Provenza #  7 , Licia Mota #  3 , Ricardo Machado Xavier  8 , Gilda Aparecida Ferreira #  2 , Marcelo Medeiros Pinheiro #  5
Affiliations

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

Claudia Marques et al. JMIR Res Protoc. .

Abstract

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.

Keywords: Brazil; COVID-19; SARS-CoV-2; chronic disease; cohort; immune-mediated rheumatic diseases; immunology; infection rate; inflammatory; morbidity; mortality; prospective study; registry.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
A nationwide task force, comprising 43 centers from 5 geographic regions in Brazil (see full organization names in Textbox 1).
Figure 2
Figure 2
Study flowchart.
Figure 3
Figure 3
Blood collection and storage protocol: The blood from the peripheral vein will be collected in a total of 16 ml: 3 EDTA tubes, one with 2 ml and two with 4 ml and 1 dry tube with separating gel. To the first EDTA tube, where 2 ml of blood was collected, 2 ml of RNAlater will be added for later storage. The second EDTA tube will be stored with total blood. The third EDTA tube will be centrifuged for plasma separation, along with the dry tube, for serum separation. Serum and plasma will be divided into 2 ml aliquots and frozen at -20ºC, together with the tube where RNAlater was added, and the EDTA tube containing whole blood.
See this image and copyright information in PMC

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