SEC asks Bharat Serums to revise phase I/II trial protocols for equine antiserum to treat COVID-19
The SEC has recommended grant of permission to conduct the clinical trial provided the company submits the revised clinical trial protocol to CDSCO
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has asked Mumbai-based Bharat Serums and Vaccines to revise the clinical trial protocol of phase I/II of its equine antiserum for the treatment of COVID-19.
The SEC has recommended for grant of permission to conduct the clinical trial after the company submits revised clinical trial protocol to CDSCO for approval with the following amendments:
1. In inclusion criteria, the definitions of the moderate patient should include SpO2 between 90 per cent to 93 per cent. And the respiratory rate should be >24 per minute, heart rate should be up to 120 per minute.
2. The WHO progression scale mentioned in the exclusion criteria should be deleted.
3. The viral clearance should be the secondary endpoint.
4. The sample size in Phase I should not be less than 30 patients.
5. The firm should present the results of Phase I study before proceeding to Phase II study.
6. The safety data should be evaluated by the Data and Safety Monitoring Board (DSMB) constituted for the study.
This year in March, the company initiated communications with the ICMR and other regulatory agencies in India to explore the possibility of co-development, fast-tracking some of the approvals that are required for initiating R&D activities, review and approval processes for pre-clinical and clinical development, etc., pertaining to the antiserum.
Thereafter, the development activities of the project including procurement of antigens required for immunisation of horses were initiated in June. Initially, the company enrolled nine equines for this project and additional equines dedicated to this project were recruited based on process scale-up requirements.
The company did not respond till the time story was filed, however, sources indicate that they intend to submit the information by month-end.