CSIR seeks regulatory nod for clinical trials using combination of antivirals and HDTs against COVID-19
It is to determine safety and efficacy of 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 Council of Scientific & Industrial Research (CSIR), in collaboration with Laxai Life Sciences Hyderabad, has sought regulatory approval to undertake four-arm randomised 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 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 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”.
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”.
This clinical trial, if successful, will provide more options for treatment of COVID-19.