Revive Therapeutics Inc (CSE:RVV) (OTC:RCCTF) told investors Wednesday that the company is finalizing agreements and aligning resources to initiate a Phase 3 clinical trial of its drug Bucillamine as a treatment for the coronavirus (COVID-19) in September.
The company received approval from the US Food and Drug Administration (FDA) last week to move forward with a trial evaluating the safety and efficacy of the drug in patients with mild-to-moderate COVID-19.
Revive said it plans to engage as many as 10 clinical trial sites in the US and will evaluate potential locations in states including Arizona, California, Florida and Texas.
READ: Revive Therapeutics gets FDA approval to start Phase 3 of possible COVID-19 treatment Bucillamine
The company is also working to secure agreements with vendors regarding project management, medical monitoring, data management and clinical packaging.
“With the FDA approval of the Phase 3 clinical study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, our team and partners are working diligently to align our resources and expertise that will fast-track the Phase 3 study,” CEO Michael Frank said in a statement.
The Phase 3 trial will enroll up to 1,000 patients that will be randomized 1:1:1 to receive either 100 mg or 200 mg of Bucillamine three times a day or a placebo for up to 14 days. The primary endpoint is the rates of hospitalization and death after four weeks of treatment.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board (DSMB) after 210 patients have been treated and followed up after the for weeks, after which researchers will select the better performing Bucillamine dose. Patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same four-week threshold.
The firm cautioned shareholders that it is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 at this time.
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