The Subject Expert Committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) has recommended that the country`s top drug regulator grant permission for phase 3 clinical trial using Thymosin @-1 injection 1.6 mg on moderate to severe COVID-19 patients, said a senior health ministry official on Wednesday. The senior government official said: "Domestic pharma giant Gufic Bioscience has submitted its application to DCGI for its permission to use Thymosin @-1 injection 1.6 mg on coronavirus patients. Our subject experts committee reviewed it thoroughly and further recommended to the Drugs Controller General of India (DGCI) for its consideration." So far, Thymosin @-1 injection 1.6 mg has been used in the treatment of chronic hepatitis B. The study title presented to the drug regulator says that an open label, multi-center two arm (standard control) randomised, phase 3 clinical study is needed to evaluate the effectiveness and safety of Thymosin @-1 injection 1.6 mg as on add on treatment to existing standard care treatment in moderate to severe COVID-19 patients.

Source: dna August 19, 2020 08:26 UTC