Revive Therapeutics submits Phase 3 trial protocol of possible COVID-19 drug Bucillamine to the Institutional Review Board

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) announced a key step forward ahead of its Phase 3 clinical trial of Bucillamine, a potential coronavirus treatment for patients with mild-to-moderate forms of COVID-19. The firm said Wednesday it had submitted the trial protocol for independent review by the Institutional Review Board (IRB) for approval. 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. READ: Revive Therapeutics Ltd broadens Phase 3 coronavirus trial of Bucillamine to Asia-Pacific and Canada 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. Michael Frank, Revive’s CEO, told investors that the company is continuing to make strong progress in its Phase 3 clinical trial. “(With) the submission of the Phase 3 study protocol to Advarra, a premier IRB services company in North America, for review and approval, it will enable us to select key clinical sites in the US and proceed with site initiation visits to allow for the selected US clinical locations to enroll patients,” Frank said in a statement. The company said it hopes to have patients enrolled by September. Contact Angela at angela@proactiveinvestors.com Follow her on Twitter @AHarmantas