Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced in a news release it received a green light from the U.S. Food and Drug Administration to conduct a Phase 3 clinical trial of Bucillamine in patients with mild to moderate COVID-19.
"The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally," said Michael Frank, Revive's CEO. "We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner."
The study will evaluate the safety and efficacy of Bucillamine. Up to 1,000 patients will be randomized on a 1:1:1 basis to receive Bucillamine 100 milligrams three times a day, Bucillamine 200 milligrams three times a day or a placebo three times a day, for up to 14 days.
The primary endpoint, the company noted, is the proportion of patients whose clinical outcome is hospitalization or death after the time of their first dose. Efficacy will be determined by comparing various elements between patients receiving Bucillamine and patients receiving a placebo. Those elements will include clinical outcome, disease severity using the National Institute of Allergy and Infectious Diseases' eight-category COVID ordinal scale, supplemental oxygen use and COVID-19 progression.
Safety will be assessed through adverse events reported before treatment and those during and immediately after treatment, along with certain lab test results, vital signs and peripheral oxygen saturation levels.
After 210 patients are treated and followed for 28 days afterward, an independent data and safety monitoring board will conduct an interim analysis. The board will determine which dose had better results, after which patients will be randomized 2:1 to that Bucillamine dose or to a placebo.
Additional interim analyses will occur after 400, 600 and 800 patients have been followed for 28 days post treatment.
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