Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS), in a news release announced that "the company's Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 received approval from the independent Institutional Review Board (IRB) at Advarra, a premier IRB services company in North America."
Revive Therapeutics' CEO Michael Frank stated, "With the IRB approval of the Phase 3 study protocol for COVID-19, we can recruit U.S. clinical sites efficiently, allowing us to move forward with providing Bucillamine to patients under our IND that was approved by the FDA last month."
The firm explained that IRBs are FDA registered constituted groups that operate under FDA regulations and are officially designated to review and monitor biomedical research involving human subjects. An IRB holds the authority to approve, require modifications or disapprove research and the primary purpose of an IRB review is to assure from start to finish that appropriate steps are taken during clinical trials to protect the rights and welfare of participating subjects.
The company stated it plans to enroll up to 1,000 patients it its Phase 3 multi-center double-blind clinical trial of Bucillamine in Patients with Mild-Moderate COVID-19. Patients in the study will be randomized to receive either 100 mg or 200 mg of Bucillamine or placebo three times per day for 14 days. The firm advised that the study's primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy versus those receiving a placebo.
The company advised that an independent data and safety monitoring board (DSMB) will perform an interim analysis after 210 patients have been treated and followed up for 28 days after randomization. After that period, the dosage level which demonstrated the best results will be chosen and randomized at a 2:1 ratio versus placebo. The DSMB will closely monitor the data and will perform additional interim analyses after 400, 600, and 800 patients complete their respective 28-day treatments.
Revive Therapeutics stated that it is specifically not making claims of any kind that its product has the ability to cure or eliminate COVID-19 (SARS-2 Coronavirus).
The company discussed the scientific basis behind the use of Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) for COVID-19 treatment and noted that "preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells."[NLINSERT]
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