Dr. Reddy’s Laboratories and Global Response Aid (GRA) have announced the termination of the Avigan Trial Study on moderate to severe Covid-19 patients in a hospital setting in Kuwait.
It was one among the studies in the overall clinical programme of the antiviral drug Avigan in asymptomatic to severe Covid-19 in both the out-patient and in-patient settings.
The latest development follows data from the Kuwait CVD-04-CD-001 study on moderate to severe Covid-19 hospitalised patients.
The trial failed to demonstrate statistically significant difference for the primary endpoint (time to sustained hypoxia resolution) for Avigan as compared with placebo.
Dr. Reddy’s noted that the full data analysis on 353 participants will be available by the end of next month.
Apart from his cohort, a subgroup analysis was carried out on 181 patients in the low-risk category.
It showed that a three-day earlier for time to hospital discharge was noted in the Avigan group versus eight days in the placebo group, thereby meeting secondary endpoint.
The subgroup analysis data hints at the potential of drugs like Avigan being effective in early treatment initiation in Covid-19 patients and not in late-stage hospital treatment for moderate and severe cases.
Dr. Reddy’s noted that Phase III PRESECO study of patients with mild to moderate Covid-19 symptoms in outpatient setting will continue in North America.
It is being conducted by the company in collaboration with Appili Therapeutics and GRA.
The study will analyse the efficacy of Avigan as an early treatment for Covid-19 patients with mild to moderate symptoms, to alleviate symptoms and preventing disease progression before needing hospitalisations or intensive interventions.
Earlier, Dr. Reddy’s announced plans to conduct a Phase III clinical trial of the Covid-19 vaccine, Sputnik V, after it received approval from the Drugs Control General of India (DCGI).