Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2021 |
| Outros Autores: | , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/49099 |
Resumo: | Inclui: Corrigendum to “Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial.” [EClinicalMedicine 37 (2021) 100981]. |
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Blum, Vinicius FontanesiCimerman, SérgioHunter, James R.Tierno, PauloLacerda, AciolySoeiro, AlexandreCardoso, FlorentinoBellei, Nancy CristinaMaricato, JulianaMantovani, NathaliaVassao, MarcelaDias, DaniloGallinskas, JulianaJanini, Luis Mario RamosOliveira, Joanna Reis SantosCruz, Alda Maria daDiaz, Ricardo Sobhie2021-09-17T10:50:54Z2021-09-17T10:50:54Z2021BLUM, Vinicius Fontanesi et al. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine, v.37, 100981, p. 1-10, June 2021.2589-5370https://www.arca.fiocruz.br/handle/icict/4909910.1016/j.eclinm.2021.100981Inclui: Corrigendum to “Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial.” [EClinicalMedicine 37 (2021) 100981].Universidade Federal de São Paulo. São Paulo, SP, Brasil.Instituto de Infectologia Emilio Ribas. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Hospital Municipal Dr. Francisco Moran (Barueri). Guarulhos, SP, Brasil.SPDM (Guarulhos). Sao Paulo, SP, BrasilINCOR and Beneficiência Portuguesa. São Paulo, SP, Brasil.Hospital Vera Cruz. Campinas, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Interdisciplinar de Pesquisa Médicas. Rio de Janeiro, RJ, Brasil.Universidade Federal de São Paulo. São Paulo, SP, Brasil.Background: The absence of specific antivirals to treat COVID-19 leads to the repositioning of candidates’ drugs. Nitazoxanide (NTZ) has a broad antiviral effect. Methods: This was a randomized, double-blind pilot clinical trial comparing NTZ 600 mg BID versus Placebo for seven days among 50 individuals (25 each arm) with SARS-COV-2 RT-PCR+ (PCR) that were hospitalized with mild respiratory insufficiency from May 20th, 2020, to September 21st, 2020 (ClinicalTrials.gov NCT04348409). Clinical and virologic endpoints and inflammatory biomarkers were evaluated. A five-point scale for disease severity (SSD) was used. Findings: Two patients died in the NTZ arm compared to 6 in the placebo arm (p = 0.564). NTZ was superior to placebo when considering SSD (p < 0001), the mean time for hospital discharge (6.6 vs. 14 days, p = 0.021), and negative PCR at day 21 (p = 0.035), whereas the placebo group presented more adverse events (p = 0.04). Among adverse events likely related to the study drug, 14 were detected in the NTZ group and 22 in placebo (p = 0.24). Among the 30 adverse events unlikely related, 21 occurred in the placebo group (p = 0.04). A decrease from baseline was higher in the NTZ group for D-Dimer (p = 0.001), US-RCP (p < 0.002), TNF (p < 0.038), IL-6 (p < 0.001), IL-8 (p = 0.014), HLA DR. on CD4+ T lymphocytes (p < 0.05), CD38 in CD4+ and CD8+ T (both p < 0.05), and CD38 and HLA-DR. on CD4+ (p < 0.01) Interpretation: Compared to placebo in clinical and virologic outcomes and improvement of inflammatory out comes, the superiority of NTZ warrants further investigation of this drug for moderate COVID-19 in larger clinical trials. A higher incidence of adverse events in the placebo arm might be attributed to COVID-19 related symptoms. Funding: This study was supported by Farmoquimica (FQM), Brazil. Laboratory testing was partially sup ported by a grant from CNPq, Brazil (RD).engElsevierNitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleCOVID-19NitazoxanideEnsaio clínico controlado randomizadoMarcadores de ativação celular linfócitosInterleucinasCOVID-19NitazoxanideRandomized controlled clinical trialLymphocytes cell activation markersInterleukinsinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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| dc.title.pt_BR.fl_str_mv |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| title |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| spellingShingle |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial Blum, Vinicius Fontanesi COVID-19 Nitazoxanide Ensaio clínico controlado randomizado Marcadores de ativação celular linfócitos Interleucinas COVID-19 Nitazoxanide Randomized controlled clinical trial Lymphocytes cell activation markers Interleukins |
| title_short |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| title_full |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| title_fullStr |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| title_full_unstemmed |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| title_sort |
Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial |
| author |
Blum, Vinicius Fontanesi |
| author_facet |
Blum, Vinicius Fontanesi Cimerman, Sérgio Hunter, James R. Tierno, Paulo Lacerda, Acioly Soeiro, Alexandre Cardoso, Florentino Bellei, Nancy Cristina Maricato, Juliana Mantovani, Nathalia Vassao, Marcela Dias, Danilo Gallinskas, Juliana Janini, Luis Mario Ramos Oliveira, Joanna Reis Santos Cruz, Alda Maria da Diaz, Ricardo Sobhie |
| author_role |
author |
| author2 |
Cimerman, Sérgio Hunter, James R. Tierno, Paulo Lacerda, Acioly Soeiro, Alexandre Cardoso, Florentino Bellei, Nancy Cristina Maricato, Juliana Mantovani, Nathalia Vassao, Marcela Dias, Danilo Gallinskas, Juliana Janini, Luis Mario Ramos Oliveira, Joanna Reis Santos Cruz, Alda Maria da Diaz, Ricardo Sobhie |
| author2_role |
author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Blum, Vinicius Fontanesi Cimerman, Sérgio Hunter, James R. Tierno, Paulo Lacerda, Acioly Soeiro, Alexandre Cardoso, Florentino Bellei, Nancy Cristina Maricato, Juliana Mantovani, Nathalia Vassao, Marcela Dias, Danilo Gallinskas, Juliana Janini, Luis Mario Ramos Oliveira, Joanna Reis Santos Cruz, Alda Maria da Diaz, Ricardo Sobhie |
| dc.subject.en.pt_BR.fl_str_mv |
COVID-19 Nitazoxanide Ensaio clínico controlado randomizado Marcadores de ativação celular linfócitos Interleucinas |
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COVID-19 Nitazoxanide Ensaio clínico controlado randomizado Marcadores de ativação celular linfócitos Interleucinas COVID-19 Nitazoxanide Randomized controlled clinical trial Lymphocytes cell activation markers Interleukins |
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COVID-19 Nitazoxanide Randomized controlled clinical trial Lymphocytes cell activation markers Interleukins |
| description |
Inclui: Corrigendum to “Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial.” [EClinicalMedicine 37 (2021) 100981]. |
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2021 |
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2021-09-17T10:50:54Z |
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2021-09-17T10:50:54Z |
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2021 |
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BLUM, Vinicius Fontanesi et al. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine, v.37, 100981, p. 1-10, June 2021. |
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10.1016/j.eclinm.2021.100981 |
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BLUM, Vinicius Fontanesi et al. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine, v.37, 100981, p. 1-10, June 2021. 2589-5370 10.1016/j.eclinm.2021.100981 |
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