The protocol will be implemented at the national health institutes in Mexico VIR-7831 candidate for phase 3 treatment which has the potential to neutralize the virus, kills infected cells and create a protective barrier in the lungs among patients at increased risk of complications from covid-19 due to diabetes, hypertension, obesity and other diseases or over 55 years of age.
This was explained by Sigfrido Rangel, medical director at GSK Mexico MILLENNIUM than the monoclonal antibody against SARS-CoV-2 will prevent patients from being complicated by chronic and degenerative diseases controlled or uncontrolled and reach the degree of intubation due to low oxygen saturation in the blood, a high degree of inflammation and infection in the lungs.
“The monoclonal antibody attacks the SARS-CoV-2 Spike protein and prevents the infection from progressing to and adhering to T cells and everyone around the lung,” he explained.
How does it work?
He biotechnology is injected into a vein for 60 to 90 minutes (during which an antibiotic is administered) and immediately blocks the S protein of SARS-CoV-2 and other receptors that affect the lung. In addition, the monoclonal antibody has the particularity of increasing the patient’s immune response so that those cells that have already been infected can fight the white blood cells.
Monoclonal antibody, developed by GSK and Vir, will be given to people who have been in contact with a positive person or who already have the first symptoms of acquiring covid-19, including new variant detected in Great Britain.
Must administered within 10 days of the first symptoms and thus prevent damage caused by coronavirus by reducing respiratory capacity, saturation levels, inflammation and lung infection, the collapse of other vital organs.
He explained that the effect is not that of a vaccine, which is intended to generate long-term immunity. It is a treatment, like the one given in any consultation, with the benefit that the person receiving the intravenous injection immediately concentrates the active substance in the lungs to block the covid-19 virus, even in other pathogens of the coronavirus family.
It also prevents the virus from replicating and infecting other cells of patients at high risk due to diabetes, hypertension, obesity, kidney disease, whether they are well controlled or not.
“In those 10 days the virus continues to replicate, so it is essential not to exceed this limit in order for there to be a protective response,” he said.
The treatment would be useful for patients such as the president Andrés Manuel López Obrador, who yesterday with signs and symptoms, has high blood pressure, although controlled, “with a single dose will get that protective effect.”
When do the tests start?
Research on VIR-7831 (also known as GSK4182136) has been performed in more than 1.30 outpatients worldwide, and Starting in February, clinical research with Mexican patients will continue with phase 3 after obtaining authorization from Federal Commission for Protection against Health Risks (Cofepris).
“We will recruit outpatients with risk factors and symptoms,” he said.
The phase 3 clinical trial will begin in February and is expected to have results in April and be authorized for treatment in May 2021.
“We are facing a deadly virus. VIR-7831 is an antibody with characteristics that can allow it to prevent hospitalization or death through multiple mechanisms, “added George Scangos, Ph.D., CEO of Vir, a development partner.
The first clinical trials conducted in the United Kingdom and San Francisco, United Statesyes, warns only of minor allergic reactions. It is not administered to minors or pregnant women.
The VIR-7831 clinical development program includes additional studies, possibly involving patients with severely ill intubation to boost their immune system.
The Independent Data Monitoring Committee recommended on 30 September 2020 that the study be continued in phase 3 on the basis of a positive assessment of safety and tolerability data from the initial phase 2 phase, “if successful, VIR-7831 has the potential to advance outpatient treatment of covid-19 ”.
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