Revive Therapeutics Granted FDA Approval For Phase 3 Clinical Trial For Bucillamine In COVID-19 Treatment

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.

FULL DISCLOSURE: Revive Therapeutics is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Revive Therapeutics on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

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