This morning Revive Therapeutics Ltd (CSE: RVV, OTV: RVVTF), announced they have selected five clinical sites in Florida, Texas and California for enrollment of patients for their Phase 3 clinical study to use Bucillamine as a treatment for COVID-19 patients. They also stated they are finalizing agreements with an additional ten clinical sites in these states including Arizona and Ohio. They expect patient enrollments for the ten additional sites to begin in October.
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 FDA approval and commercialization of Bucillamine for the treatment of COVID-19.”
Michael Frank, Revive’s Chief Executive Officer
The Phase 3 clinical trial will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day, Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
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