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

Autor: Vinicius Fontanesi Blum, Sérgio Cimerman, James R Hunter, Paulo Tierno, Acioly Lacerda, Alexandre Soeiro, Florentino Cardoso, Nancy Cristina Bellei, Juliana Maricato, Nathalia Mantovani, Marcella Vassao, Danilo Dias, Juliana Galinskas, Luis Mário Ramos Janini, Joanna Reis Santos-Oliveira, Alda Maria Da-Cruz, Ricardo Sobhie Diaz
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: EClinicalMedicine, Vol 37, Iss , Pp 100981- (2021)
Druh dokumentu: article
ISSN: 2589-5370
DOI: 10.1016/j.eclinm.2021.100981
Popis: 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
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