Revive Therapeutics Ltd (CSE:RVV) (OTC:RVVTF) has selected five sites in Florida, Texas and California where it will begin enrolling patients for a Phase 3 trial of its drug Bucillamine in patient with mild-to-moderate cases of the coronavirus (COVID-19).
The company has finalized agreements with five clinical sites and is working out the details with an additional 10 sites in those states, as well as in Arizona and Ohio. Patient enrollment is expected to begin in October, the company said.
The Phase 3 trial will enroll as many as 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg, Bucillamine 200 mg or a placebo three times a day for up to 14 days.
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The plan is to compare the frequency of hospitalization or death in patients receiving Bucillamine with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death after four weeks.
“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,” CEO Michael Frank said in a statement.
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 company said. 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.
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