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Dr Reddy’s Laboratories Ltd and Global Response Aid FZCO (GRA) announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting.
The hospitalised patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical programme for Avigan, spanning the spectrum of asymptomatic to severe cases of COVID in both outpatient and in-patient setting. The Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America by Dr Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, shall continue.
The data from the Kuwait CVD-04-CD-001 study involving moderate-severe COVID 19 hospitalised patients did not show statistically significant difference for the primary endpoint (ie time to sustained hypoxia resolution) for Avigan vs Placebo (7 days vs 8 days; p= >0.05). The full data analysis on 353 subjects would be available by the end of February 2021.
Dr Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, shall continue the Phase 3 pivotal study [PRESECO] being conducted in North America in an out-patient setting. The PRESECO study aims to determine the efficacy of Avigan as an early treatment for COVID-19 patients with mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalisations or other intensive interventions. Additional observational studies to evaluate the efficacy of Avigan as part of early treatment in COVID 19 patients are also initiated.
Avigan® is a trademark of FUJIFILM Toyama Chemical Co, Ltd.
