Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced in a news release it finalized five clinical sites at which its Phase 3 clinical trial, to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19, will be conducted.
"We have made significant progress in advancing the Phase 3 clinical trial since the FDA approval allowed us to proceed with the study, and we are expanding on and engaging with clinical sites in high prevalence COVID-19 infected states, which will enable us to meet our enrollment goals and expedite the potential U.S. Food and Drug Administration approval and commercialization of Bucillamine for the treatment of COVID-19," Revive CEO Michael Frank said in the release.
Enrollment will now begin at these five sites, which are in California, Texas and Florida. Revive also is in the process of finalizing agreements with 10 more sites in other states, including Arizona and Ohio. Enrollment at those additional locations would begin in October. Up to 1,000 patients in all will be enrolled for the study.
Participating patients will be randomized on a 1:1:1 to basis to receive Bucillamine 100 mg, Bucillamine 200 mg or placebo, administered three times a day for up to 14 days.
The company noted that an interim analysis will be "performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and 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 post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports," the company noted.
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