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Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
BACKGROUND: Nitazoxanide exerts antiviral activity in vitro and in vivo and anti-inflammatory effects, but its impact on patients hospitalized with COVID-19 pneumonia is uncertain. METHODS: A multicentre, randomized, double-blind, placebo-controlled trial was conducted in 19 hospitals in Brazil. Hos...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9043450/ https://www.ncbi.nlm.nih.gov/pubmed/35492335 http://dx.doi.org/10.3389/fmed.2022.844728 |
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author | Rocco, Patricia R. M. Silva, Pedro L. Cruz, Fernanda F. Tierno, Paulo F. G. M. M. Rabello, Eucir Junior, Jéfiton Cordeiro Haag, Firmino de Ávila, Renata E. da Silva, Joana D. G. Mamede, Mariana M. S. Buchele, Konrad S. Barbosa, Luiz C. V. Cabral, Anna C. Junqueira, Antônio A. F. Araújo-Filho, João A. da Costa, Lucianna A. T. J. Alvarenga, Pedro P. M. Moura, Alexandre S. Carajeleascow, Ricardo de Oliveira, Mirella C. Silva, Roberta G. F. Soares, Cynthia R. P. Fernandes, Ana Paula S. M. Fonseca, Flavio Guimarães Camargos, Vidyleison Neves Reis, Julia de Souza Franchini, Kleber G. Luiz, Ronir R. Morais, Sirlei Sverdloff, Carlos Martins, Camila Marinelli Felix, Nathane S. Mattos-Silva, Paula Nogueira, Caroline M. B. Caldeira, Dayene A. F. Pelosi, Paolo Lapa-e-Silva, José R. |
author_facet | Rocco, Patricia R. M. Silva, Pedro L. Cruz, Fernanda F. Tierno, Paulo F. G. M. M. Rabello, Eucir Junior, Jéfiton Cordeiro Haag, Firmino de Ávila, Renata E. da Silva, Joana D. G. Mamede, Mariana M. S. Buchele, Konrad S. Barbosa, Luiz C. V. Cabral, Anna C. Junqueira, Antônio A. F. Araújo-Filho, João A. da Costa, Lucianna A. T. J. Alvarenga, Pedro P. M. Moura, Alexandre S. Carajeleascow, Ricardo de Oliveira, Mirella C. Silva, Roberta G. F. Soares, Cynthia R. P. Fernandes, Ana Paula S. M. Fonseca, Flavio Guimarães Camargos, Vidyleison Neves Reis, Julia de Souza Franchini, Kleber G. Luiz, Ronir R. Morais, Sirlei Sverdloff, Carlos Martins, Camila Marinelli Felix, Nathane S. Mattos-Silva, Paula Nogueira, Caroline M. B. Caldeira, Dayene A. F. Pelosi, Paolo Lapa-e-Silva, José R. |
author_sort | Rocco, Patricia R. M. |
collection | PubMed |
description | BACKGROUND: Nitazoxanide exerts antiviral activity in vitro and in vivo and anti-inflammatory effects, but its impact on patients hospitalized with COVID-19 pneumonia is uncertain. METHODS: A multicentre, randomized, double-blind, placebo-controlled trial was conducted in 19 hospitals in Brazil. Hospitalized adult patients requiring supplemental oxygen, with COVID-19 symptoms and a chest computed tomography scan suggestive of viral pneumonia or positive RT-PCR test for COVID-19 were enrolled. Patients were randomized 1:1 to receive nitazoxanide (500 mg) or placebo, 3 times daily, for 5 days, and were followed for 14 days. The primary outcome was intensive care unit admission due to the need for invasive mechanical ventilation. Secondary outcomes included clinical improvement, hospital discharge, oxygen requirements, death, and adverse events within 14 days. RESULTS: Of the 498 patients, 405 (202 in the nitazoxanide group and 203 in the placebo group) were included in the analyses. Admission to the intensive care unit did not differ between the groups (hazard ratio [95% confidence interval], 0.68 [0.38–1.20], p = 0.179); death rates also did not differ. Nitazoxanide improved the clinical outcome (2.75 [2.21–3.43], p < 0.0001), time to hospital discharge (1.37 [1.11–1.71], p = 0.005), and reduced oxygen requirements (0.77 [0.64–0.94], p = 0.011). C-reactive protein, D-dimer, and ferritin levels were lower in the nitazoxanide group than the placebo group on day 7. No serious adverse events were observed. CONCLUSIONS: Nitazoxanide, compared with placebo, did not prevent admission to the intensive care unit for patients hospitalized with COVID-19 pneumonia. CLINICAL TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (REBEC) RBR88bs9x; ClinicalTrials.gov, NCT04561219. |
format | Online Article Text |
id | pubmed-9043450 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-90434502022-04-28 Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial Rocco, Patricia R. M. Silva, Pedro L. Cruz, Fernanda F. Tierno, Paulo F. G. M. M. Rabello, Eucir Junior, Jéfiton Cordeiro Haag, Firmino de Ávila, Renata E. da Silva, Joana D. G. Mamede, Mariana M. S. Buchele, Konrad S. Barbosa, Luiz C. V. Cabral, Anna C. Junqueira, Antônio A. F. Araújo-Filho, João A. da Costa, Lucianna A. T. J. Alvarenga, Pedro P. M. Moura, Alexandre S. Carajeleascow, Ricardo de Oliveira, Mirella C. Silva, Roberta G. F. Soares, Cynthia R. P. Fernandes, Ana Paula S. M. Fonseca, Flavio Guimarães Camargos, Vidyleison Neves Reis, Julia de Souza Franchini, Kleber G. Luiz, Ronir R. Morais, Sirlei Sverdloff, Carlos Martins, Camila Marinelli Felix, Nathane S. Mattos-Silva, Paula Nogueira, Caroline M. B. Caldeira, Dayene A. F. Pelosi, Paolo Lapa-e-Silva, José R. Front Med (Lausanne) Medicine BACKGROUND: Nitazoxanide exerts antiviral activity in vitro and in vivo and anti-inflammatory effects, but its impact on patients hospitalized with COVID-19 pneumonia is uncertain. METHODS: A multicentre, randomized, double-blind, placebo-controlled trial was conducted in 19 hospitals in Brazil. Hospitalized adult patients requiring supplemental oxygen, with COVID-19 symptoms and a chest computed tomography scan suggestive of viral pneumonia or positive RT-PCR test for COVID-19 were enrolled. Patients were randomized 1:1 to receive nitazoxanide (500 mg) or placebo, 3 times daily, for 5 days, and were followed for 14 days. The primary outcome was intensive care unit admission due to the need for invasive mechanical ventilation. Secondary outcomes included clinical improvement, hospital discharge, oxygen requirements, death, and adverse events within 14 days. RESULTS: Of the 498 patients, 405 (202 in the nitazoxanide group and 203 in the placebo group) were included in the analyses. Admission to the intensive care unit did not differ between the groups (hazard ratio [95% confidence interval], 0.68 [0.38–1.20], p = 0.179); death rates also did not differ. Nitazoxanide improved the clinical outcome (2.75 [2.21–3.43], p < 0.0001), time to hospital discharge (1.37 [1.11–1.71], p = 0.005), and reduced oxygen requirements (0.77 [0.64–0.94], p = 0.011). C-reactive protein, D-dimer, and ferritin levels were lower in the nitazoxanide group than the placebo group on day 7. No serious adverse events were observed. CONCLUSIONS: Nitazoxanide, compared with placebo, did not prevent admission to the intensive care unit for patients hospitalized with COVID-19 pneumonia. CLINICAL TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (REBEC) RBR88bs9x; ClinicalTrials.gov, NCT04561219. Frontiers Media S.A. 2022-04-13 /pmc/articles/PMC9043450/ /pubmed/35492335 http://dx.doi.org/10.3389/fmed.2022.844728 Text en Copyright © 2022 Rocco, Silva, Cruz, Tierno, Rabello, Junior, Haag, de Ávila, da Silva, Mamede, Buchele, Barbosa, Cabral, Junqueira, Araújo-Filho, da Costa, Alvarenga, Moura, Carajeleascow, de Oliveira, Silva, Soares, Fernandes, Fonseca, Camargos, Reis, Franchini, Luiz, Morais, Sverdloff, Martins, Felix, Mattos-Silva, Nogueira, Caldeira, Pelosi and Lapa-e-Silva. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Rocco, Patricia R. M. Silva, Pedro L. Cruz, Fernanda F. Tierno, Paulo F. G. M. M. Rabello, Eucir Junior, Jéfiton Cordeiro Haag, Firmino de Ávila, Renata E. da Silva, Joana D. G. Mamede, Mariana M. S. Buchele, Konrad S. Barbosa, Luiz C. V. Cabral, Anna C. Junqueira, Antônio A. F. Araújo-Filho, João A. da Costa, Lucianna A. T. J. Alvarenga, Pedro P. M. Moura, Alexandre S. Carajeleascow, Ricardo de Oliveira, Mirella C. Silva, Roberta G. F. Soares, Cynthia R. P. Fernandes, Ana Paula S. M. Fonseca, Flavio Guimarães Camargos, Vidyleison Neves Reis, Julia de Souza Franchini, Kleber G. Luiz, Ronir R. Morais, Sirlei Sverdloff, Carlos Martins, Camila Marinelli Felix, Nathane S. Mattos-Silva, Paula Nogueira, Caroline M. B. Caldeira, Dayene A. F. Pelosi, Paolo Lapa-e-Silva, José R. Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
title | Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
title_full | Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
title_fullStr | Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
title_full_unstemmed | Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
title_short | Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial |
title_sort | nitazoxanide in patients hospitalized with covid-19 pneumonia: a multicentre, randomized, double-blind, placebo-controlled trial |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9043450/ https://www.ncbi.nlm.nih.gov/pubmed/35492335 http://dx.doi.org/10.3389/fmed.2022.844728 |
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