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0 0.5 1 1.5 2+ Mortality 67% Improvement Relative Risk Ventilation 62% Severity scores 20% no CI Hospitalization time 56% Viral clearance 90% Nitazoxanide  Blum et al.  LATE TREATMENT  DB RCT Is late treatment with nitazoxanide beneficial for COVID-19? Double-blind RCT 50 patients in Brazil (May - September 2020) Shorter hospitalization (p=0.021) and improved viral clearance (p=0.035) Blum et al., EClinicalMedicine, January 2021 Favors nitazoxanide Favors control

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

Blum et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100981 (date from preprint), NCT04348409
Jan 2021  
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RCT with 25 nitazoxanide patients and 25 control patients, showing improved virological and clinical outcomes with treatment.
Authors also perform an in vitro study in Vero E6 cells showing 90% inhibition with 0.5µM, with no cytotoxicity. NCT04348409 (history).
risk of death, 66.7% lower, RR 0.33, p = 0.25, treatment 2 of 25 (8.0%), control 6 of 25 (24.0%), NNT 6.3.
risk of mechanical ventilation, 62.5% lower, RR 0.38, p = 0.17, treatment 3 of 25 (12.0%), control 8 of 25 (32.0%), NNT 5.0.
relative severity scores, 20.2% better, RR 0.80, treatment 25, control 25.
hospitalization time, 55.7% lower, relative time 0.44, p = 0.02, treatment 25, control 25.
risk of no viral clearance, 89.8% lower, RR 0.10, p = 0.03, treatment 0 of 23 (0.0%), control 4 of 19 (21.1%), NNT 4.8, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 21.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Blum et al., 22 Jan 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 17 authors, study period 20 May, 2020 - 21 September, 2020, trial NCT04348409 (history).
This PaperNitazoxanideAll
Nitazoxanide superiority to placebo to treat moderate COVID-19 – A Pilot prove of concept randomized double-blind clinical trial.
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
eClinicalMedicine, doi:10.1016/j.eclinm.2021.100981
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 20 th , 2020, to September 21 st , 2020 ( 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 outcomes, 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.
Declaration of Competing Interest VB exerts activities of clinical research at FQM Farmoquímica, sponsor of the study. AL reports grants from FQM, during the conduct of the study; personal fees from Daiicho Sankyo Brasil, Pfizer, Mantecorp Ind ustria Química e Farmacêutica, Libs Farmacêutica, Sanofi-Aventis; grants, personal fees and non-financial support from Janssen Pharmaceutical; personal fees and non-financial support from Cristalia Produtos Químicos e Farmacêuticos; grants and personal fees from Eli Lilly; grants from H. Lundbeck A/S, Servier Laboratories, Hoffman-La Roche, Forum Pharmaceuticals, Biophytis, Ganentech, Cellavita, Celltrion (outside the submitted work). JG, DD, JH, and NM report personal fees from FMQ during the conduct of the study. SC reports grants from FQM during the conduct of the study; grants from MERCK SHARP & DOME, NOVARTIS, ROCHE, ABBVIE, GILEAD, and PFIZER (outside the submitted work). Other authors do not have any conflict of interest to declare. Supplementary materials Supplementary material associated with this article can be found in the online version at doi:10.1016/j.eclinm.2021.100981.
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Late treatment
is less effective
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