Mexico continues nitazoxanide research against COVID-19
The Lancet recently published a study demonstrating the efficacy of nitazoxanide (NTZ) in treating patients with moderate COVID-19. The objective was to evaluate the efficacy of NTZ compared to placebo in a group of patients with moderate COVID-19 disease. Patients with a compatible clinical picture and positive RT-PCR for SARS-COV-2 in nasal and oropharyngeal swabs were selected.
The double-blind, randomized, proof-of-concept pilot trial compared nitazoxanide versus placebo for seven days among 50 patients with SARS-COV-2 RT-PCR + (PCR) who were hospitalized with mild respiratory failure from May 20 to September 21, 2020.
Clinical and virological endpoints and inflammatory biomarkers were evaluated, obtaining a reduction in viral load and thereby decreasing hospitalization time due to clinical improvement. A faster negative PCR test for SARS-CoV-2 and positive impact on inflammatory markers were also documented.
Similarly, the nitazoxanide-treated group was superior when outcomes such as a decrease in disease symptoms, oxygen clearance, and hospital discharge were assessed.
These results allow further exploration of the benefits and antiviral effects of nitazoxanide for COVID-19. It was initially developed for the treatment of protozoal disease. The antiviral properties of nitazoxanide and its metabolite - tizoxanide - have generated increasing interest in recent years due to its demonstrated ability to act as a broad-spectrum antiviral agent through multiple mechanisms. Also, as an inclusion to be considered as an effective agent against COVID-19.
And is that in the absence of specific antivirals to treat COVID-19, this research leads to the redirection of candidate drugs, such as nitazoxanide (NTZ). By demonstrating a broad antiviral effect, it is suggested within research protocols around COVID-19 in different dosing regimens in search of proving to be a suitable antiviral drug.
Mexico awaits approval
In this regard, there are proposals to use NTZ as the only drug or in combination with other antivirals in countries such as the United States. Currently in studies for FDA approval, Argentina, Mexico, Egypt, and Nigeria. Since in various experimental models it is postulated that the combination of more than one drug is necessary to increase the potency of antiviral treatment. In this context, NTZ may have antiviral activity in more than one step of the SARS-COV-2 replication cycle.
As references prior to this investigation, the literature was searched using the terms "SARS-CoV-2 or coronavirus or COVID-19, or virus" and "Nitazoxanide ". We found in vitro and some clinical trials showing evidence of its antiviral effect against a variety of viruses. Among them, influenza, respiratory syncytial virus, Ebola, norovirus, rotavirus, adenovirus, coronavirus, chikungunya virus, hepatitis B virus. This situation refers to the broad antiviral spectrum of NTZ already known years ago.
Six hospitals participate in nitazoxanide study
The group of investigators who conducted this study noted confidence in the favorable clinical and laboratory results. They report feeling motivated to continue with a phase 3 study for moderate to severe COVID-19. It should be noted that this was a multicenter study with the participation of six hospitals in the State of São Paulo, Brazil, and was supported by the Roemmers Pharmaceutical Group of Argentina, which is represented in Mexico by Siegfried Rhein, a pharmaceutical company that has the innovative nitazoxanide in its product portfolio.
The study protocol, as well as all data files concerning the results, as well as the programs to process the files, are deposited in a publicly available repository in the GitLab system for this clinical trial: https://gitlab.com/jameshunterbr/ntz-clinical-trial