It’s a big day for Revive Therapeutics (CSE: RVV) (OTC: RVVTF). The company announced this morning that the US Food and Drug Administration has approved the company’s application for a Phase 3 Clinical Trial for the study of utilizing Bucillamine in the treatment of patients with mild-moderate COVID-19.
The Phase 3 clinical trial will see a randomized, double-blind, placebo-controlled confirmatory study conducted to evaluate the safety and efficacy of Bucillamine in the treatment of the infectious disease. The clinical study, entitled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19,” will see up to 1,000 patients enrolled for testing.
Under the study, patients will be randomized 1:1:1 initially to test the efficacy of two different dosages of Bucillamine in the treatment of COVID-19, with one group being subject to a placebo. Dosages will be administered for a period of up to 14 days, with the objective being to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 among the three groups.
Efficacy of Bucillamine under the study will be analyzed based on a number of factors, including clinical outcome, disease severity, supplemental oxygen use, and progression of the disease among those whom receive the drug and those of whom receive a placebo.
After 210 patients have been studied for a period of 28 days, the study will then select the better performing dosage of Bucillamine and study it on on 2:1 basis with that of a placebo to further study the efficacy of the drug.
The company intends to execute on the Phase 3 clinical trial in an “expeditious manner.” Full scientific rationale for the use of Bucillamine in the treatment of infectious diseases such as COVID-19 can be found here.
Revive Therapeutics last traded at $0.24 on the CSE.
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