India to carry out its Phase III trial of a COVID-19 drug--MUCOVIN ? Is Modi eyeing for an announcement on India's Independence day

India's premier Research Institute (CSIR) in collaboration with Laxai Life Sciences would be carrying out a four-arm randomized controlled Phase III clinical trial of MUCOVIN drug-using combinations of antiviral and host-directed therapies.

The clinical trial would be carried out in partnership with Medanta Medicity that would include a total of 300 patients in four different groups of 75 patients in the trial. It would be carried out for 17 to 21 days including screening and treatment.

The hurriedness shown by the CSIR indicates that they have been asked from the “Top’ to come up with some 'definite solution' on COVID 19 on or before August 15—if not vaccine at least a drug for COVID patients.

MUCOVIN is a unique combinatorial strategy (antivirals and HDTs) with repurposed drugs having complementary, additive and the synergistic role. The drug has been adopted to increase therapeutic options for Covid-19 treatment and help recover patients faster, claims the CSIR DG, Dr Shekhar C. Mande.

Earlier there were two vaccines going for Phase I & II trial—one COVAXIN developed by Bharat Biotech and second  ZyCov-D Vaccine developed by Zydus Cadila. However, when it was criticized world over by scientists that it is not possible on or before August 15, CSIR appears to have opted for Phase III trial of MUCOVIN drug targeting it to be over in 21 days maximum.

Council of Scientific & Industrial Research (CSIR—A premier Indian Government science research Institute) in collaboration with Laxai Life Sciences Pvt. Ltd. Hyderabad has sought regulatory approval to undertake a four-arm randomized controlled phase III clinical trial.

The design principle of the study is to rationally combine and repurpose antivirals (viral-entry and replication inhibitors) and host-directed therapies (HDTs) addressing the disease-spread and pathology simultaneously and to determine the safety and efficacy of the three combination drugs (Favipiravir+Colchicine, Umifenovir+Colchicine and Nafamostat+5-ALA) and a control arm with the standard of care in COVID-19 patients.

The clinical trial named MUCOVIN, to be carried out in the partnership with Medanta Medicity will include a total of 300 patients in four different groups of 75 patients in the trials to be carried for 17 to 21 days including screening and treatment.

Dr Shekhar C. Mande, DG, CSIR highlighted that this unique combinatorial strategy (antivirals and HDTs) with repurposed drugs having a complementary, additive and synergistic role, has been adopted to increase therapeutic options for Covid-19 treatment and help recover patients faster. The partner CSIR institutes in this important clinical trial are the CSIR-Indian Institute of Chemical Technology, Hyderabad and CSIR-Indian Institute of Integrative Medicine, Jammu.

Dr Ram S. Upadhayaya CEO, Laxai Life Sciences stated that “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”. Mr Vamsi Maddipatla, MD of Laxai Life Sciences add “The co-sponsorship of this study by Laxai Life Sciences highlights the company’s commitment to bringing life-saving therapies in the service of humanity”.

BY Vijay Thakur, Special Representative, The Statesman, vijaythakurx@gmail.com