Hyderabad-based Laxai Life Sciences Private Limited, in association with the Council of Scientific & Industrial Research (CSIR), has sought regulatory approval to undertake four-arm randomized controlled phase III clinical trial on July 8.
The clinical trial named MUCOVIN is to be carried out in partnership with Medanta Medicity in Delhi and will include a total of 300 patients in four groups of 75. The trials will be held over 17 to 21 days, including screening and treatment.
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-aminolevulinic acid — and a control arm with the standard of care in COVID-19 patients.
CSIR Director-General Dr. Shekhar C. Mande said 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 patients recover faster.
The partner CSIR institutes in this important clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.
“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”, said Laxai Life Sciences CEO Dr. Ram S. Upadhayaya. “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,” said MD Vamsi Maddipatla.
Specifically, the organisations decided to work for synthesis of drugs being used in the fight against coronavirus with focus on Umifenovir, Remdesivir and a key intermediate of Hydroxy Chloroquine (HCQ). The 'MUCOVIN' clinical trials, if successful, will provide more options for treatment of COVID-19, a CSIR release said.