Romark to seek EUA for antiviral compound to treat COVID-19

14 April 2021
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Privately-held Romark Laboratories has announced initial results from a Phase III trial of its oral investigational antiviral compound NT-300 (nitazoxanide extended-release tablets, 300mg) as a treatment for people aged 12 and older with COVID-19.

In the analysis of the primary endpoint for all evaluable patients, median time to sustained response was similar for subjects treated with NT-300 compared with placebo, at approximately 13 days. The median time to sustained response for a sub-group of evaluable patients with mild disease was reduced by 3.1 days with NT-300.

However, in looking at a key secondary endpoint, NT-300 reduced progression to severe disease in all evaluable patients by 85% compared with placebo. Only one person in the treatment arm progressed to severe COVID-19 disease.

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