DCGI gives nod to start phase-1 human trials of equine ‘antisera’ to treat COVID-19

DCGI gives nod to start phase-1 human trials of equine ‘antisera’ to treat COVID-19

The Drugs Controller General of India (DCGI) has given nod for initiating the phase-1 human clinical trial for a new “antisera” as a potential treatment for COVID-19, announced the Indian Council of Medical Research (ICMR), officials.

The antisera was developed by ICMR in collaboration with a bio-pharmaceutical firm Biological E Limited via injecting inactivated SARS-CoV-2 virus in horses.

“With Biological E Limited we have developed a horse ‘antisera’ and we have just got clearance for conducting clinical trials for that,” ICMR Director-General Dr Balram Bhargava said at a press briefing.

Antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections.

Although plasma recovered from patients experiencing COVID-19 could serve a similar purpose, the profile of antibodies, their efficacy and concentration keep varying from one patient to another and therefore, make it an unreliable clinical tool for patient management,” said the ICMR.

“Standardisation achievable through equine sera based treatment modality thus stands out as yet another remarkable public health initiative supported by ICMR in the time of COVID-19,” it said.

The pre-print version of the study regarding the development of the equine antisera has been posted on the Research Square platform.

“The study provides evidence of the potential of generating highly purified F(ab’)2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralisation activity,” the study paper said.

“Further, in-vivo testing for efficacy of this indigenously developed, the cost-effective product will pave the way to clinical evaluation. Additionally, being a donor independent method, this may prove as an efficient alternative to convalescent plasma for treatment of COVID-19 patients,” it said.

As part of the study, 10 healthy horses were immunised with inactivated SARS-CoV-2 and after 21 days of immunisation, plasma samples were tested. The results of the plasma samples indicated the presence of SARS-CoV-2 specific IgG antibodies as detected in ELISA with neutralising capacity.