Romark presents clinical trial outcome of COVID-19 treatment tablet

U.S.-based Romark Laboratories has revealed Phase 3 clinical trial results of its investigational new drug (IND) candidate, nitazoxanide extended-release tablets (NT-300), against placebo as a treatment for moderate COVID-19.

The multicenter, randomized, double-blind trial included 1,092 candidates aged 12 years and above with respiratory symptoms consistent with COVID-19. These candidates were administered at outpatient centers across the U.S. within 72 hours of showing symptoms and were treated either with two NT-300 tablets or placebo two times a day for five consecutive days.

The efficacy analyses was focused on 379 participants who had lab-confirmed COVID-19 infection at baseline. In the analysis, treatment with NT-300 was associated with an 85% reduction in the progression to severe COVID illness.

However, only one candidate subjected to NT-300 showed progression to severe COVID-19 disease. According to CDC criteria focused on the subgroup at high risk of severe illness, precisely 7/126 of placebo-treated candidates experienced severe illness compared to 1/112 of NT-300-treated subjects.

Jean-François Rossignol, M.D., Ph.D., Chief Medical and Scientific Officer, Romark, mentioned that in view of the enormous toll of the COVID-19 pandemic and the continuing public health risk, the company is delighted to present these clinical trial outcomes that show a compelling reduction in progression to severe COVID-19 with early NT-300 treatment.

In par with vaccines and treatments for acute illness, there is an urgent unmet need for oral treatments that can be administered outside of a hospital setting to reduce disease progression. Results attained from this trial are comparatively favorably with therapeutics that have received Emergency Use Authorization at hospitals on patients with high risk of developing severe COVID-19.

Source claim that following the recently attained outcomes, Romark is seeking to work with the U.S. FDA (Food and Drug Administration) for attain an Emergency Use Authorization (EUA) for NT-300.

Source Credit: https://www.prnewswire.com/news-releases/romark-announces-initial-results-of-phase-3-clinical-trial-of-nt-300-tablets-for-the-treatment-of-covid-19-301268321.html