Chronic use of hydroxychloroquine did not protect against COVID-19 in a large cohort of patients with rheumatic diseases in Brazil
Gecilmara Salviato Pileggi, Gilda Aparecida Ferreira, Ana Paula Monteiro Gomides Reis, Edgard Torres Reis-Neto, Mirhelen Mendes Abreu, Cleandro Pires Albuquerque, Nafice Costa Araújo, Ana Beatriz Bacchiega, Dante Valdetaro Bianchi, Blanca Bica, Eloisa Duarte Bonfa, Eduardo Ferreira Borba, Danielle Christinne Soares Egypto Brito, Ângela Luzia Branco Pinto Duarte, Rafaela Cavalheiro Espírito Santo, Paula Reale Fernandes, Mariana Peixoto Guimarães, Kirla Wagner Poti Gomes, Adriana Maria Kakehasi, Evandro Mendes Klumb, Cristina Costa Duarte Lanna, Claudia Diniz Lopes Marques, Odirlei André Monticielo, Licia Maria Henrique Mota, Gabriela Araújo Munhoz, Eduardo Santos Paiva, Helena Lucia Alves Pereira, José Roberto Provenza, Sandra Lucia Euzébio Ribeiro, Laurindo Ferreira Rocha Junior, Camila Santana Justo Cintra Sampaio, Vanderson Souza Sampaio, Emília Inoue Sato, Thelma Skare, Viviane Angelina De Souza, Valeria Valim, Marcus Vinícius Guimarães Lacerda, Ricardo Machado Xavier, Marcelo Medeiros Pinheiro
Advances in Rheumatology, doi:10.1186/s42358-021-00217-0
Background: There is a lack of information on the role of chronic use of hydroxychloroquine during the SARS-CoV-2 outbreak. Our aim was to compare the occurrence of COVID-19 between rheumatic disease patients on hydroxychloroquine with individuals from the same household not taking the drug during the first 8 weeks of community viral transmission in Brazil. Methods: This baseline cross-sectional analysis is part of a 24-week observational multi-center study involving 22 Brazilian academic outpatient centers. All information regarding COVID-19 symptoms, epidemiological, clinical, and demographic data were recorded on a specific web-based platform using telephone calls from physicians and medical students. COVID-19 was defined according to the Brazilian Ministry of Health (BMH) criteria. Mann-Whitney, Chisquare and Exact Fisher tests were used for statistical analysis and two binary Final Logistic Regression Model by Wald test were developed using a backward-stepwise method for the presence of COVID-19. Results: From March 29th to May 17st, 2020, a total of 10,443 participants were enrolled, including 5166 (53.9%) rheumatic disease patients, of whom 82.5% had systemic erythematosus lupus, 7.8% rheumatoid arthritis, 3.7% Sjögren's syndrome and 0.8% systemic sclerosis. In total, 1822 (19.1%) participants reported flu symptoms within the 30 days prior to enrollment, of which 3.1% fulfilled the BMH criteria, but with no significant difference between
Authors' contributions MMP, GSP, LHMH, GAF, CDLM, AMK, RMX, APMGR, ESP, ETRN, defined as Steering Committee, and MVGL conceived the study, developed the protocol and wrote the manuscript with input from all other authors. In addition, all authors are responsible for collecting data and processing, management them and statistical analysis. All authors read and approved the final manuscript.
Declarations Ethics approval and consent to participate This protocol was approved by the Brazilian Committee of Ethics in Human Research -CONEP on March 27 th , 2020 (CAAE 30246120.3.1001.5505). The informed consent process was conducted by phone, as CONEP waived the requirement for the written informed consent form due to the COVID-19 social distancing constraints. This study was registered at the Brazilian Registry of Clinical Trials (ReBEC; RBR -9KTWX6). All sections are in accordance with STROBE guidelines.
Consent for publication The consent of publication was given together with the consent of participation fol all participants and Investigators.
Competing interests The authors declare that they have no competing interests.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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' <jats:title>Background</jats:title>\n'
' <jats:p>There is a lack of information on the role of chronic use of '
'hydroxychloroquine during the SARS-CoV-2 outbreak. Our aim was to compare the occurrence of '
'COVID-19 between rheumatic disease patients on hydroxychloroquine with individuals from the '
'same household not taking the drug during the first 8\xa0weeks of community viral '
'transmission in Brazil.\n'
'</jats:p>\n'
' </jats:sec><jats:sec>\n'
' <jats:title>Methods</jats:title>\n'
' <jats:p>This baseline cross-sectional analysis is part of a 24-week '
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'method for the presence of COVID-19.</jats:p>\n'
' </jats:sec><jats:sec>\n'
' <jats:title>Results</jats:title>\n'
' <jats:p>From March 29th to May 17st, 2020, a total of 10,443 participants '
'were enrolled, including 5166 (53.9%) rheumatic disease patients, of whom 82.5% had systemic '
'erythematosus lupus, 7.8% rheumatoid arthritis, 3.7% Sjögren’s syndrome and 0.8% systemic '
'sclerosis. In total, 1822 (19.1%) participants reported flu symptoms within the 30\xa0days '
'prior to enrollment, of which 3.1% fulfilled the BMH criteria, but with no significant '
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'protective effect (OR 0.674; 95% CI 0.46–0.98).</jats:p>\n'
' </jats:sec><jats:sec>\n'
' <jats:title>Conclusion</jats:title>\n'
' <jats:p>Patients with rheumatic disease on hydroxychloroquine presented a '
'similar occurrence of COVID-19 to household cohabitants, suggesting a lack of any protective '
'role against SARS-CoV-2 infection.</jats:p>\n'
' <jats:p><jats:italic>Trial registration</jats:italic> Brazilian Registry of '
'Clinical Trials (ReBEC; RBR – 9KTWX6).</jats:p>\n'
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