Nitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial

dc.creatorBlum, Vinicius Fontanesi
dc.creatorCimerman, Sérgio
dc.creatorHunter, James R.
dc.creatorTierno, Paulo
dc.creatorLacerda, Acioly
dc.creatorSoeiro, Alexandre
dc.creatorCardoso, Florentino
dc.creatorBellei, Nancy Cristina
dc.creatorMaricato, Juliana
dc.creatorMantovani, Nathalia
dc.creatorVassao, Marcela
dc.creatorDias, Danilo
dc.creatorGallinskas, Juliana
dc.creatorJanini, Luis Mario Ramos
dc.creatorOliveira, Joanna Reis Santos
dc.creatorCruz, Alda Maria da
dc.creatorDiaz, Ricardo Sobhie
dc.date2021-09-17T10:50:54Z
dc.date2021-09-17T10:50:54Z
dc.date2021
dc.date.accessioned2023-09-26T23:03:30Z
dc.date.available2023-09-26T23:03:30Z
dc.identifierBLUM, 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.identifier2589-5370
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/49099
dc.identifier10.1016/j.eclinm.2021.100981
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8886353
dc.descriptionInclui: 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.descriptionBackground: 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.formatapplication/pdf
dc.formatapplication/pdf
dc.languageeng
dc.publisherElsevier
dc.rightsopen access
dc.subjectCOVID-19
dc.subjectNitazoxanide
dc.subjectEnsaio clínico controlado randomizado
dc.subjectMarcadores de ativação celular linfócitos
dc.subjectInterleucinas
dc.subjectCOVID-19
dc.subjectNitazoxanide
dc.subjectRandomized controlled clinical trial
dc.subjectLymphocytes cell activation markers
dc.subjectInterleukins
dc.titleNitazoxanide superiority to placebo to treat moderate COVID-19 A Pilot prove of concept randomized double-blind clinical trial
dc.typeArticle


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