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paroxysm of CoV2019 - an approved BLAZE
5 July 2021
The Eli Lilly and Company, USA healthcare provider has conducted a randomized, double-blind, placebo-controlled clinical trial studying the bamlanivimab (a.k.a LY-CoV555 or LY3819253) and etesevimab (a.k.a LY-CoV016 or LY3832479) monoclonal antibodies, administered together for the treatment of patients with mild to moderate COVID-19. The updates on this regard can be verified at the NIH Gov. Identifier: NCT04427501 (clinicaltrial.gov) and on covid19.lilly.com, updated May 2021.
Monoclonal antibodies are immune system proteins that are created in the lab. Antibodies are produced naturally by your body and help the immune system recognize the covid virus, and mark them for destruction. Like your body’s own antibodies, monoclonal antibodies (MAb) recognize specific targets and MAb based therapies are called monotherapy.
LY-CoV555, a potent antibody that is against the spike protein was derived from the plasma of a COVID-19 patient. The antibody then was developed by Eli Lilly as MAb after its discovery by researchers at the Vaccine research centre of the National Institute of Allergy and Infectious diseases. Its protection against SARS-CoV-2 has been reported in non-human primates. In October 2020 a paper published at the NEJM.org (PMID:33113295) by a team of researchers, the BLAZE-1 investigators have reported the safety precautions, adverse events and viral load reduction in patients compared to the placebo group in which a total of 467 patients participated in the study. The trial groups were divided into three categories each receiving 700mg, 2800mg and 7000mg of LY-CoV555 and 150 receiving placebo. On the 29th day of intravenous injection of the MAb, only 1.6% of patients were hospitalized under the LY-CoV555 group whereas 6.3% of patients were hospitalised under the placebo group, stating the safety and progressive action of the MAb. By February 2021, FDA approved the emergency use of bamlanivimab (LY-CoV555) 700mg and it's cocktail combined with etesevimab (LY-CoV016) 1400mg, (PMID: 33655250) to treat mild to severe COVID19 patients aged 12 and above.
By June 2021, Eli Lilly, India has received the restricted emergency use of its monoclonal drug cocktail with bamlanivimab 700 mg and etesevimab 1400 mg. In May Lilly’s other drug cocktail of Baricitinib and Remdesivir was approved by central drugs standard control organisation to treat suspected or confirmed COVID-19 patients.
Another monoclonal antibody cocktail is Regeneron's REGN-COV2 antibody, now partnered with ROCHE for mass production. One other is Zydus Cadila, the very first Indian pharmaceutical company to get approval for its antibody clinal trial. Alongside the sequence surveillance of COVID virus and RT PCR viral load detection helping the medicos in better diagnosis, the repurposed drugs like 2DG or be it remdesiver, or considering the mono-immuno-therapy are giving good hopes in treating COVID patients and prevents their hospitalization.
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