Plasma therapy may not have shown any benefit during recent trials, but the Indian Council for Medical Research (ICMR), the country’s biological research regulator, has received approval from the national drug controller to conduct a clinical trial. on animal derived antibodies against Sars-Cov. -2, the virus that causes coronavirus disease (Covid-19), for the treatment of patients.
Antibodies from animals, or sera derived from animals, are also called antisera. The ICMR will conduct clinical trials on horse-derived antibodies.
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ICMR together with Hyderabad-based Biological E. Limited have developed highly purified antisera to treat Covid-19 patients.
“We have developed equine sera and developed a horse serum with Biological E, which can also be considered. We have completed some studies in equine sera, where we have a predictive dose of antibodies in an ampoule, which is a small sealed glass capsule that contains the dose that can be injected. We are awaiting an authorization for a clinical trial with horse sera, ”said Dr. Balram Bhargava, CEO of ICMR, on Tuesday at the Covid-19 information meeting of the Union Ministry of Health and Family Welfare (MoH & FW) .
Previously, it has been tested with equine sera to treat various viral and bacterial infections such as rabies, hepatitis B, vaccinia virus, tetanus, botulism, and diphtheria.
“Although plasma recovered from Covid-19 patients could serve a similar purpose, the antibody profile, efficacy and concentration vary from patient to patient. As a result, it becomes an unreliable clinical tool for managing Covid-19 patients, ”ICMR said earlier in a statement.
“Achievable standardization through the equine serum-based treatment modality stands out as another notable public health initiative endorsed by the ICMR in the time of Covid-19,” he added.
The ICMR study on determining the efficacy of plasma therapy in treating Covid-19 patients was conducted on 464 patients in 39 hospitals in India, with at least 350 physicians participating in the study.
“… And it clearly showed no benefit in reducing mortality in moderate to severe cases of Covid-19. It also did not stop the progression of the disease from moderate to severe. This was well established. This publication has been reviewed and accepted as a full article in the British Medical Journal, one of the most prestigious journals in the world. At the moment, a preprint has been published, but the full article will be published soon, ”said Dr. Bhargava.
“However, on the trail of that, we have developed equine sera to be used in the treatment of Covid-19,” he added.
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