dc.creator | Blum, Vinicius Fontanesi | |
dc.creator | Cimerman, Sérgio | |
dc.creator | Hunter, James R. | |
dc.creator | Tierno, Paulo | |
dc.creator | Lacerda, Acioly | |
dc.creator | Soeiro, Alexandre | |
dc.creator | Cardoso, Florentino | |
dc.creator | Bellei, Nancy Cristina | |
dc.creator | Maricato, Juliana | |
dc.creator | Mantovani, Nathalia | |
dc.creator | Vassao, Marcela | |
dc.creator | Dias, Danilo | |
dc.creator | Gallinskas, Juliana | |
dc.creator | Janini, Luis Mario Ramos | |
dc.creator | Oliveira, Joanna Reis Santos | |
dc.creator | Cruz, Alda Maria da | |
dc.creator | Diaz, Ricardo Sobhie | |
dc.date | 2021-09-17T10:50:54Z | |
dc.date | 2021-09-17T10:50:54Z | |
dc.date | 2021 | |
dc.date.accessioned | 2023-09-26T23:03:30Z | |
dc.date.available | 2023-09-26T23:03:30Z | |
dc.identifier | 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. | |
dc.identifier | 2589-5370 | |
dc.identifier | https://www.arca.fiocruz.br/handle/icict/49099 | |
dc.identifier | 10.1016/j.eclinm.2021.100981 | |
dc.identifier.uri | https://repositorioslatinoamericanos.uchile.cl/handle/2250/8886353 | |
dc.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]. | |
dc.description | 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). | |
dc.format | application/pdf | |
dc.format | application/pdf | |
dc.language | eng | |
dc.publisher | Elsevier | |
dc.rights | open access | |
dc.subject | COVID-19 | |
dc.subject | Nitazoxanide | |
dc.subject | Ensaio clínico controlado randomizado | |
dc.subject | Marcadores de ativação celular linfócitos | |
dc.subject | Interleucinas | |
dc.subject | COVID-19 | |
dc.subject | Nitazoxanide | |
dc.subject | Randomized controlled clinical trial | |
dc.subject | Lymphocytes cell activation markers | |
dc.subject | Interleukins | |
dc.title | Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial | |
dc.type | Article | |