Author | Rocco, Patricia R. M. | |
Author | Silva, Pedro L. | |
Author | Cruz, Fernanda F. | |
Author | M. Junior, Marco Antonio C. | |
Author | Tierno, Paulo F. G. M. M. | |
Author | Moura, Marcos A. | |
Author | Oliveira, Luís Frederico G. de | |
Author | Lima, Cristiano C. | |
Author | Santos, Ezequiel A. dos | |
Author | F. Junior, Walter | |
Author | Fernandes, Ana Paula S. M. | |
Author | Franchini, Kleber G. | |
Author | Magri, Erick | |
Author | Moraes, Nara F. de | |
Author | Gonçalves, José Mário J. | |
Author | Carbonieri, Melanie N. | |
Author | Santos, Ivonise S. dos | |
Author | Paes, Natália F. | |
Author | Maciel, Paula V. M. | |
Author | Rocha, Raissa P. | |
Author | Carvalho, Alex F. de | |
Author | Alves, Pedro Augusto | |
Author | Modena, José Luiz P. | |
Author | Cordeiro, Artur T. | |
Author | Trivella, Daniela B. B. | |
Author | Marques, Rafael E. | |
Author | Luiz, Ronir R. | |
Author | Pelosi, Paolo | |
Author | Silva, Jose Roberto Lapa e | |
Access date | 2022-03-17T16:49:55Z | |
Available date | 2022-03-17T16:49:55Z | |
Document date | 2021 | |
Citation | ROCCO, Patrícia R. M. et al. Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial. The European Respiratory Journal, p. 1-67, 2020. | pt_BR |
ISSN | 0903-1936 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/51724 | |
Abstract in Portuguese | Nitazoxanide is widely available and exerts broad-spectrum antiviral activity in vitro. However, there is no evidence of its impact on SARS-CoV-2 infection. In a multicenter, randomised, double-blind, placebo-controlled trial, adult patients presenting up to 3 days after onset of Covid-19 symptoms (dry cough, fever, and/or fatigue) were enrolled. After confirmation of SARS-CoV2 infection by RT-PCR on a nasopharyngeal swab, patients were randomised 1:1 to receive either nitazoxanide (500 mg) or placebo, TID, for 5 days. The primary outcome was complete resolution of symptoms. Secondary outcomes were viral load, laboratory tests, serum biomarkers of inflammation, and hospitalisation rate. Adverse events were also assessed. From June 8 to August 20, 2020, 1575 patients were screened. Of these, 392 (198 placebo, 194 nitazoxanide) were analysed. Median time from symptom onset to first dose of study drug was 5 (4–5) days. At the 5-day study visit, symptom resolution did not differ between the nitazoxanide and placebo arms. Swabs collected were negative for SARS-CoV-2 in 29.9% of patients in the nitazoxanide arm versus 18.2% in the placebo arm (p=0.009). Viral load was also reduced after nitazoxanide compared to placebo (p=0.006). The percent viral load reduction from onset to end of therapy was higher with nitazoxanide (55%) than placebo (45%) (p=0.013). Other secondary outcomes were not significantly different. No serious adverse events were observed. In patients with mild Covid-19, symptom resolution did not differ between nitazoxanide and placebo groups after 5 days of therapy. However, early nitazoxanide therapy was safe and reduced viral load significantly. | pt_BR |
Language | eng | pt_BR |
Publisher | European Respiratory Society | pt_BR |
Previous version | https://www.arca.fiocruz.br/handle/icict/46293 | pt_BR |
Rights | open access | pt_BR |
Title | Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial | pt_BR |
Type | Article | pt_BR |
DOI | 10.1183/13993003.03725-2020 | |
Affilliation | Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil. | pt_BR |
Affilliation | Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil. | pt_BR |
Affilliation | Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil. | pt_BR |
Affilliation | Hospital Municipal de Emergências Albert Sabin. São Caetano, SP, Brazil. | pt_BR |
Affilliation | Hospital Municipal de Barueri Dr Francisco Moran. Barueri, SP, Brazil. | pt_BR |
Affilliation | Hospital e Maternidade Therezinha de Jesus. Juiz de Fora, MG, Brazil. | pt_BR |
Affilliation | Hospital Santa Casa de Misericórdia de Sorocaba. Sorocaba, SP, Brazil. | pt_BR |
Affilliation | Secretaria de Estado de Saúde do Distrito Federal, Brasília, DF, Brazil. | pt_BR |
Affilliation | Secretaria Municipal de Saúde de Bauru. Bauru, SP, Brazil. | pt_BR |
Affilliation | Secretaria Municipal de Saúde de Guarulhos. Guarulhos, SP, Brazil. | pt_BR |
Affilliation | Universidade Federal de Minas Gerais.Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil. | pt_BR |
Affilliation | Brazilian National Biosciences Laboratory and Brazilian Center for Energy and Materials Research. Campinas, SP, Brazil. | pt_BR |
Affilliation | Hospital Municipal de Emergências Albert Sabin. São Caetano, SP, Brazil. | pt_BR |
Affilliation | Hospital Municipal de Barueri Dr Francisco Moran. Barueri, SP, Brazil. | pt_BR |
Affilliation | Hospital e Maternidade Therezinha de Jesus. Juiz de Fora, MG, Brazil. | pt_BR |
Affilliation | Hospital Santa Casa de Misericórdia de Sorocaba. Sorocaba, SP, Brazil. | pt_BR |
Affilliation | Secretaria de Estado de Saúde do Distrito Federal, Brasília. DF, Brazil. | pt_BR |
Affilliation | Secretaria Municipal de Saúde de Bauru. Bauru, SP, Brazil. | pt_BR |
Affilliation | Secretaria Municipal de Saúde de Guarulhos. Guarulhos, SP, Brazil. | pt_BR |
Affilliation | Centro de Tecnologia de Vacinas. Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brazil. | pt_BR |
Affilliation | Centro de Tecnologia de Vacinas. Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brazil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil. | pt_BR |
Affilliation | State University of Campinas. Campinas, SP, Brazil. | pt_BR |
Affilliation | Brazilian National Biosciences Laboratory and Brazilian Center for Energy and Materials Research. Campinas, SP, Brazil. | pt_BR |
Affilliation | Brazilian National Biosciences Laboratory and Brazilian Center for Energy and Materials Research. Campinas, SP, Brazil. | pt_BR |
Affilliation | Brazilian National Biosciences Laboratory and Brazilian Center for Energy and Materials Research. Campinas, SP, Brazil. | pt_BR |
Affilliation | Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil. | pt_BR |
Affilliation | State University of Campinas. Campinas, SP, Brazil. | pt_BR |
Affilliation | Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil. | pt_BR |
Subject | SARS-CoV-2 | pt_BR |
Subject | COVID-19 | pt_BR |
Subject | Drugs | pt_BR |
Subject | Nitazoxanide | pt_BR |