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COVID-19: Subject Expert Committee seeks DCGI's nod to use hepatitis injection for phase III clinical trial

So far, Thymosin @-1 injection 1.6 mg has been used in the treatment of chronic hepatitis B.

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COVID-19: Subject Expert Committee seeks DCGI's nod to use hepatitis injection for phase III clinical trial
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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.

It is important to note that in the absence of a potential drug or vaccine against coronavirus infection, scientists and pharma experts around the world are conducting clinical trials to evaluate the efficacy of a medicine to combat the coronavirus pandemic.

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