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Revive Therapeutics is set to expand the Phase III clinical trial of Bucillamine as a potential treatment for mild to moderate Covid-19 in Asia-Pacific Countries (APAC) and Canada.
Earlier this month, the company received approval from the US Food and Drug Administration (FDA) to conduct a Phase III trial of the drug in this indication.
The Phase III study is intended to assess Bucillamine’s safety and efficacy.
Revive Therapeutics CEO Michael Frank said: “With the approval from the FDA to conduct the Phase III clinical trial in Covid-19 and our progress that we have made to date, we are now establishing plans to complement and support our initiatives in the US to include clinical sites in APAC and Canada.”
Participant enrolment and dosing in the Phase III study is scheduled to start next month.
The company and its clinical trial partners are exploring potential sites and clinical investigators in the US, APAC and Canada.
Up to 1,000 patients will be enrolled during the Phase III trial. Participants will be given Bucillamine 100mg or 200mg three times a day or placebo TID for up to 14 days.
The primary objective is the frequency of hospitalisation or death, while the primary endpoint is the proportion of patients reaching a composite endpoint of hospitalsation or death from the time of first dose to day 28 after randomisation.
Efficacy will be determined as clinical outcome, disease severity with the eight-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of the disease.
The safety assessment will be based on pre-treatment adverse events, treatment-emergent adverse events, laboratory values, vital signs, and peripheral oxygen saturation.
An Independent Data and Safety Monitoring Board (DSMB) will conduct an interim analysis after treatment of 210 patients and their follow-up for 28 days following randomisation.