In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced it is preparing to launch the Phase 3 clinical trial of Bucillamine for mild to moderate COVID-19 in September 2020, now that it has U.S. Food and Drug Administration approval to proceed.
"Our team and partners are working diligently to align our resources and expertise that will fast-track the Phase 3 study," Revive's CEO Michael Frank said in the release.
The Ontario, Canada-based company expects to recruit up to 10 U.S. sites to participate in the study and open the Phase 3 clinical trial for patient screening in Q3-2020. Revive and its clinical trial partners will begin evaluating potential clinical sites and clinical investigators in states with major COVID-10 outbreaks, such as California, Arizona, Texas and Florida.
Revive also is currently finalizing vendor agreements for project management, medical monitoring, data management and clinical packaging, all in relation to carrying out the study at various locations.
The company stated that the "Phase 3 confirmatory clinical study titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo."
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