| Author | Blum, Vinicius Fontanesi | |
| Author | Cimerman, Sérgio | |
| Author | Hunter, James R. | |
| Author | Tierno, Paulo | |
| Author | Lacerda, Acioly | |
| Author | Soeiro, Alexandre | |
| Author | Cardoso, Florentino | |
| Author | Bellei, Nancy Cristina | |
| Author | Maricato, Juliana | |
| Author | Mantovani, Nathalia | |
| Author | Vassao, Marcela | |
| Author | Dias, Danilo | |
| Author | Gallinskas, Juliana | |
| Author | Janini, Luis Mario Ramos | |
| Author | Oliveira, Joanna Reis Santos | |
| Author | Cruz, Alda Maria da | |
| Author | Diaz, Ricardo Sobhie | |
| Access date | 2021-09-17T10:50:54Z | |
| Available date | 2021-09-17T10:50:54Z | |
| Document date | 2021 | |
| Citation | 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. | pt_BR |
| ISSN | 2589-5370 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/49099 | |
| 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]. | pt_BR |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | open access | |
| Title | Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial | pt_BR |
| Type | Article | |
| DOI | 10.1016/j.eclinm.2021.100981 | pt_BR |
| Abstract | 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). | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Instituto de Infectologia Emilio Ribas. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Hospital Municipal Dr. Francisco Moran (Barueri). Guarulhos, SP, Brasil. | pt_BR |
| Affilliation | SPDM (Guarulhos). Sao Paulo, SP, Brasil | pt_BR |
| Affilliation | INCOR and Beneficiência Portuguesa. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Hospital Vera Cruz. Campinas, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Interdisciplinar de Pesquisa Médicas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil. | pt_BR |
| Subject | COVID-19 | pt_BR |
| Subject | Nitazoxanide | pt_BR |
| Subject | Ensaio clínico controlado randomizado | pt_BR |
| Subject | Marcadores de ativação celular linfócitos | pt_BR |
| Subject | Interleucinas | pt_BR |
| Subject in Spanish | COVID-19 | pt_BR |
| Subject in Spanish | Nitazoxanide | pt_BR |
| Subject in Spanish | Randomized controlled clinical trial | pt_BR |
| Subject in Spanish | Lymphocytes cell activation markers | pt_BR |
| Subject in Spanish | Interleukins | pt_BR |
