Mumbai-based Bharat Serums and Vaccines (BSV) will conduct clinical trials on 160 volunteers to study the safety and efficacy of a potential treatment using equine antibody for hospitalised Covid-19 patients. The recruitment of clinical trial volunteers is going on in 11 sites across the country. The company’s effort to find a new method to treat Covid-19 patients comes at a time when India is in the midst of a third wave of infection.
“BSV has developed Equine Covid-19 antiserum from horse serum for the use in Covid-19 infection. The indication proposed is to provide passive immunization to the Covid-19 infected patient thereby reducing the viral load and prevention of disease progression. Clinical phase 1 and phase 2 studies have been planned to be conducted. The phase 1 study will be conducted on two dosages to find the safety and tolerability in patients. Based on the results of phase 1 study the phase 2 shall be initiated,” says the description of the trial in the US National Institute of Health’s clinical trial registry.
Sanjiv Navangul, managing director and CEO of BSV, says the equine antibody can be broadly classified as a treatment vaccine as it is meant to be administered to hospitalised Covid-19 patients.
The disclosure made by BSV in the Clinical Trials Registry of India (CTRI) indicates that the sites identified for conducting clinical trials are Aster Prime Hospital (Hyderabad), Medanta (Gurgaon), Jehangir Hospital and Vishwaraj Hospital (Pune), Hindusthan Hospital (Coimbatore), KLES Hospital (Belgaum), NKP Salve Institute (Nagpur), Victoria Hospital and BGS Global Institute (Bengaluru), Vinaya Hospital (Mangalore) and Amrita Institute (Ernakulam).
“Covid is not going to vanish in thin air. It might sustain in different forms and variants a little longer. Knowing that what you need is something to be given as antibody which neutralizes the Covid-19 infection in the hospital immediately. It is therefore like a treatment vaccine. Not many have tried this route, we hear some studies are being done in Brazil, and the results are good, but these are early stage studies. We want the Phase I and II to be over. If it works it will become a global story (in Covid-19 treatment),” Navangul says.
BSV is a 50-year-old privately held company that operates in niche segments like assisted reproductive technology, critical care, emergency medicine, neurology, nephrology, hematology and urology. Navangul claims BSV to be a market leader in equine products, and a dominant player in women’s health hormones used for infertility treatment.