Revive Therapeutics wins Institutional Review Board approval for its Phase 3 trial protocol to evaluate Bucillamine in COVID-19 patients

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) announced Monday that its Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-to-moderate COVID-19 received approval from the independent Institutional Review Board at Advarra, a premier IRB services company in North America. “With the IRB approval of the Phase 3 study protocol for COVID-19, we can recruit US clinical sites efficiently, allowing us to move forward with providing Bucillamine to patients under our Investigational New Drug (IND) application that was approved by the FDA last month,” said Revive CEO Michael Frank in a statement.  An IRB operates under US Food and Drug Administration regulations and is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. READ: Revive Therapeutics submits Phase 3 trial protocol of possible COVID-19 drug Bucillamine to the Institutional Review Board In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. The purpose of IRB review is to assure, both in advance and by periodic review, those appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.  Phase 3 of the global study will look at up to 1,000 patients that will be randomized 1:1:1 to receive 100 milligrams (mg) of Bucillamine, 200 mg or a placebo three times a day for up to 14 days, in order to evaluate the safety and efficacy of the drug. Toronto-based Revive also said it is exploring the possibility of treating COVID-19 patients with Bucillamine under the US Food and Drug Administration’s Expanded Access Program, also known as the Compassionate Use Program, allowing patients to receive an investigational drug for a serious disease or condition. Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham