Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional do Centro Universitário La Salle |
Texto Completo: | http://hdl.handle.net/11690/1899 |
Resumo: | BACKGROUND Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited. METHODS We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed. RESULTS A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent. CONCLUSIONS Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.) |
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Cavalcanti, Alexandre B.Zampieri, Fernando G.Rosa, Regis G.Azevedo, Luciano C. P.Veiga, Viviane C.Avezum, AlvaroDamiani, Lucas P.Marcadenti, AlineKawano-Dourado, LetíciaLisboa, ThiagoJunqueira, Debora L. M.Silva, Pedro G. M. de Barros ETramujas, LucasAbreu-Silva, Erlon O.Laranjeira, Ligia N.Soares, Aline T.Echenique, Leandro S.Pereira, Adriano J.Freitas, Flávio G. R.Gebara, Otávio C. E.Dantas, Vicente C. S.Furtado, Remo H. M.Milan, Eveline P.Golin, Nicole A.Cardoso, Fábio F.Maia, Israel S.Hoffmann Filho, Conrado R.Kormann, Adrian P. M.Amazonas, Roberto B.Oliveira, Monalisa F. Bocchi deSerpa-Neto, AryFalavigna, MaiconLopes, Renato D.Machado, Flávia R.Berwanger, Otavio2021-07-30T17:29:03Z2021-07-30T17:29:03Z2020CAVALCANTI, A. B. et al. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N. Engl. J. Med., v. 383, n. 21, p. 2041-2052, nov., 2020. Disponível em: https://www.nejm.org/doi/10.1056/NEJMoa2019014?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Acesso e: 22 jul. 2021.http://hdl.handle.net/11690/1899BACKGROUND Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited. METHODS We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed. RESULTS A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent. CONCLUSIONS Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.)Submitted by DSpace Unilasalle (dspace@unilasalle.edu.br) on 2021-07-30T17:29:03Z No. of bitstreams: 1 Hydroxychloroquine with or without Azithromycin_NEJM.pdf: 657905 bytes, checksum: abd774ed0fca84d1bf82fc915cc48491 (MD5)Made available in DSpace on 2021-07-30T17:29:03Z (GMT). No. of bitstreams: 1 Hydroxychloroquine with or without Azithromycin_NEJM.pdf: 657905 bytes, checksum: abd774ed0fca84d1bf82fc915cc48491 (MD5) Previous issue date: 2020Massachusetts Medical SocietyHydroxychloroquineAzithromycinMild-to-Moderate Covid-19Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessengreponame:Repositório Institucional do Centro Universitário La Salleinstname:Universidade La Salle (UNILASALLE)instacron:UNILASALLEORIGINALHydroxychloroquine with or without Azithromycin_NEJM.pdfHydroxychloroquine with or without Azithromycin_NEJM.pdfOpen Accessapplication/pdf657905http://svr-net20.unilasalle.edu.br:8080/jspui/bitstream/11690/1899/1/Hydroxychloroquine%20with%20or%20without%20Azithromycin_NEJM.pdfabd774ed0fca84d1bf82fc915cc48491MD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81748http://svr-net20.unilasalle.edu.br:8080/jspui/bitstream/11690/1899/2/license.txt8a4605be74aa9ea9d79846c1fba20a33MD5211690/18992021-07-30 14:30:57.616oai:svr-net20.unilasalle.edu.br: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Repositório Institucionalopendoar:2021-07-30T17:30:57Repositório Institucional do Centro Universitário La Salle - Universidade La Salle (UNILASALLE)false |
dc.title.pt_BR.fl_str_mv |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
title |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
spellingShingle |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 Cavalcanti, Alexandre B. Hydroxychloroquine Azithromycin Mild-to-Moderate Covid-19 |
title_short |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
title_full |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
title_fullStr |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
title_full_unstemmed |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
title_sort |
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 |
author |
Cavalcanti, Alexandre B. |
author_facet |
Cavalcanti, Alexandre B. Zampieri, Fernando G. Rosa, Regis G. Azevedo, Luciano C. P. Veiga, Viviane C. Avezum, Alvaro Damiani, Lucas P. Marcadenti, Aline Kawano-Dourado, Letícia Lisboa, Thiago Junqueira, Debora L. M. Silva, Pedro G. M. de Barros E Tramujas, Lucas Abreu-Silva, Erlon O. Laranjeira, Ligia N. Soares, Aline T. Echenique, Leandro S. Pereira, Adriano J. Freitas, Flávio G. R. Gebara, Otávio C. E. Dantas, Vicente C. S. Furtado, Remo H. M. Milan, Eveline P. Golin, Nicole A. Cardoso, Fábio F. Maia, Israel S. Hoffmann Filho, Conrado R. Kormann, Adrian P. M. Amazonas, Roberto B. Oliveira, Monalisa F. Bocchi de Serpa-Neto, Ary Falavigna, Maicon Lopes, Renato D. Machado, Flávia R. Berwanger, Otavio |
author_role |
author |
author2 |
Zampieri, Fernando G. Rosa, Regis G. Azevedo, Luciano C. P. Veiga, Viviane C. Avezum, Alvaro Damiani, Lucas P. Marcadenti, Aline Kawano-Dourado, Letícia Lisboa, Thiago Junqueira, Debora L. M. Silva, Pedro G. M. de Barros E Tramujas, Lucas Abreu-Silva, Erlon O. Laranjeira, Ligia N. Soares, Aline T. Echenique, Leandro S. Pereira, Adriano J. Freitas, Flávio G. R. Gebara, Otávio C. E. Dantas, Vicente C. S. Furtado, Remo H. M. Milan, Eveline P. Golin, Nicole A. Cardoso, Fábio F. Maia, Israel S. Hoffmann Filho, Conrado R. Kormann, Adrian P. M. Amazonas, Roberto B. Oliveira, Monalisa F. Bocchi de Serpa-Neto, Ary Falavigna, Maicon Lopes, Renato D. Machado, Flávia R. Berwanger, Otavio |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Cavalcanti, Alexandre B. Zampieri, Fernando G. Rosa, Regis G. Azevedo, Luciano C. P. Veiga, Viviane C. Avezum, Alvaro Damiani, Lucas P. Marcadenti, Aline Kawano-Dourado, Letícia Lisboa, Thiago Junqueira, Debora L. M. Silva, Pedro G. M. de Barros E Tramujas, Lucas Abreu-Silva, Erlon O. Laranjeira, Ligia N. Soares, Aline T. Echenique, Leandro S. Pereira, Adriano J. Freitas, Flávio G. R. Gebara, Otávio C. E. Dantas, Vicente C. S. Furtado, Remo H. M. Milan, Eveline P. Golin, Nicole A. Cardoso, Fábio F. Maia, Israel S. Hoffmann Filho, Conrado R. Kormann, Adrian P. M. Amazonas, Roberto B. Oliveira, Monalisa F. Bocchi de Serpa-Neto, Ary Falavigna, Maicon Lopes, Renato D. Machado, Flávia R. Berwanger, Otavio |
dc.subject.por.fl_str_mv |
Hydroxychloroquine Azithromycin Mild-to-Moderate Covid-19 |
topic |
Hydroxychloroquine Azithromycin Mild-to-Moderate Covid-19 |
description |
BACKGROUND Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited. METHODS We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed. RESULTS A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent. CONCLUSIONS Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.) |
publishDate |
2020 |
dc.date.issued.fl_str_mv |
2020 |
dc.date.accessioned.fl_str_mv |
2021-07-30T17:29:03Z |
dc.date.available.fl_str_mv |
2021-07-30T17:29:03Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
CAVALCANTI, A. B. et al. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N. Engl. J. Med., v. 383, n. 21, p. 2041-2052, nov., 2020. Disponível em: https://www.nejm.org/doi/10.1056/NEJMoa2019014?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Acesso e: 22 jul. 2021. |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/11690/1899 |
identifier_str_mv |
CAVALCANTI, A. B. et al. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. N. Engl. J. Med., v. 383, n. 21, p. 2041-2052, nov., 2020. Disponível em: https://www.nejm.org/doi/10.1056/NEJMoa2019014?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Acesso e: 22 jul. 2021. |
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http://hdl.handle.net/11690/1899 |
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Massachusetts Medical Society |
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Massachusetts Medical Society |
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