The Council of Scientific & Industrial Research (CSIR), in collaboration with Laxai Life Sciences Pvt Ltd, Hyderabad, has sought regulatory approval to undertake controlled phase III clinical trial using a combination of three different drugs to treat COVID-19 patients, a statement said on Tuesday.
The purpose behind the clinical trial is to rationally combine and repurpose antivirals and determine safety and efficacy of the three combination drugs (Favipiravir+Colchicine, Umifenovir+Colchicine and Nafamostat+5-ALA).
The clinical trial named MUCOVIN, to be carried out in partnership with Medanta Medicity, will include a total of 300 patients in four different groups of 75 each. The trials will be conducted for 17 to 21 days including screening and treatment, the statement said.
Shekhar Mande, director general of the CSIR, said each group of patients will be administered one set of drugs.
This unique combinatorial strategy (antivirals and HDTs) with repurposed drugs having complementary, additive and synergistic roles, has been adopted to increase therapeutic options for COVID-19 treatment and help recover patients faster, he said.
On CSIR’s part, its two institutes — Indian Institute of Chemical Technology, Hyderabad and Indian Institute of Integrative Medicine, Jammu — are part of the exercise.
Ram S Upadhayaya, CEO, Laxai Life Sciences said the study aims to target viral proteins essential for its replication as well as host factors that play a crucial role in the viral life cycle and contribute to the cytokine storm.
Since the outbreak of the COVID-19 pandemic, the CSIR has been repurposing several drugs to check their efficacy for treating the coronavirus patients.