Revive Files IND Application With FDA For Phase 3 Clinical Study For COVID-19 Treatment
Revive Therapeutics (CSE: RVV) announced after the bell today that it has officially filed its investigational new drug (IND) application to the US FDA for its Phase 3 confirmatory study. The study will focus on utilizing bucillamine as a potential treatment for COVID-19 and other infectious diseases.
Once the application is accepted, Revive will conduct a placebo-controlled study which will be both randomized and be double-blind in patients with mild to moderate COVID-19. The study is currently estimated to take place in the third quarter of 2020. The study is said to consist of up to 800 patients, with will see patients receive either 100 mg of Bucillamine three times a day, 200 mg three times a day, or a placebo three times a day for up to a 14 day period.
The objective of the study will be to measure the effects of Bucillamine in terms of frequency of hospitalization and mortality in these patients between the three dosages. Efficacy will be measured based on clinical outcome, severity of the disease, supplemental oxygen use, and progression of the disease based on dosage received. Analysis will be performed on the first 210 patients treated and followed up on for a total of 28 days after the first dose is administered. The best performing dosage will then be used on a 2:1 basis with a placebo for the remainder of the study, with further analysis occurring at every 100 person interval through to 700.
Full scientific rationale for the use of Bucillamine in the treatment of infectious diseases such as COVID-19 can be found here. Further details on the phase 3 study to be conducted by Revive Therapeutics can be found in the news release published by the company, found here.
Revive Therapeutics last traded at $0.29 on the CSE.
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