Mumbai: Council of Scientific & Industrial Research (CSIR), in collaboration with Laxai Life Sciences Pvt. Ltd. Hyderabad, has sought regulatory approval to undertake four-arm randomized controlled phase III clinical trial.
The design principle of the study is to rationally combine and re purpose antivirals (viral-entry and replication inhibitors) and host-directed therapies (HDTs) addressing the disease-spread and pathology simultaneously and to determine 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 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 crucial role in the viral life cycle and contribute to the cytokine storm”. Mr. Vamsi Maddipatla, MD of Laxai Life Sciences adds “The co-sponsorship of this study by Laxai Life Sciences highlights the company’s commitment in bringing life-saving therapies in the service of humanity”.
These clinical trials add to the several contributions CSIR has made during the pandemic and if the trial is successful, it will provide more options for treatment of COVID-19.