In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced that it got approval from an independent investigational review board to proceed with its expanded access protocol for the compassionate use of Bucillamine, in hospitalized patients with severe COVID-19.
Revive's expanded access program, which is covered by the U.S. Food and Drug Administration's compassionate use provision, gives qualifying patients access to Bucillamine through their physicians.
Participating inpatients will be administered Bucillamine 200 milligrams orally three times a day for up to 14 days and will be monitored during that period for side effects and drug safety and efficacy. Subsequently, a study nurse will conduct two safety assessments with the participants, at 14 and 42 weeks post completion of treatment.
Revive is carrying out this program as a complement to its Phase 3 COVID-19 trial in the U.S., for which enrollment should begin this month.
"The expanded access protocol (EAP) serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19, and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine," Revive CEO Michael Frank explained in the release.
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