The protocol will be carried out in national health institutes in Mexico Phase 3 of the candidate treatment VIR-7831 which has the potential to neutralize the virus, kill infected cells and create one protective barrier in the lungs of patients at high risk of complications from covid-19 due to diabetes, hypertension, obesity and other pathologies, or who are over 55 years of age.
Sigfrido Rangel, medical director of GSK Mexico, explained to MILLENNIUM than the monoclonal antibody against SARS-CoV-2 it will prevent patients from getting complicated by having chronic and degenerative diseases controlled or uncontrolled, and reach the degree of intubation due to low oxygen saturation in the blood, 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 and attaching to the T cells and all those surrounding the lung,” he explained.
How it works?
the biotech is injected into the vein for 60 to 90 minutes (Time at which an antibiotic is supplied) and immediately blocks SARS-CoV-2 protein S and other receptors that injure the lung. In addition, the monoclonal antibody has the particularity of elevating the patient’s immune response so that it can fight with its white blood cells those cells that were already infected.
The monoclonal antibody, developed by GSK and the company Vir, It will be supplied to people who have been in contact with a positive person or who already have the first symptoms of having acquired covid-19, including new variant detected in the UK.
It is due supply within a maximum of 10 days of having the first symptoms and thereby prevent the damage caused by the coronavirus by decreasing respiratory capacity, saturation levels, inflammation and lung infection, the collapse of the rest of the vital organs.
He detailed that the effect is not that of a vaccine, which aims to generate long-term immunity. It is a treatment, as given in all consultations, with the benefit that the person on receiving the intravenous injection immediately the active substance is concentrated in the lung to block covid-19 virus. , even to other pathogens of the coronavirus family.
Also, it prevents the virus from replicating and infecting other high-risk patient cells from having diabetes, hypertension, obesity, kidney disease, regardless of whether or not they are well controlled.
“In these 10 days the virus continues to replicate so it is essential not to exceed this limit so that there is a protective response,” he said.
The treatment would be helpful for patients like the president Andrés Manuel López workr, who yesterday with signs and symptoms, has hypertension although controlled, “with a single dose will achieve this protective effect.”
When do the tests start?
Research on VIR-7831 (also known as GSK4182136) has been conducted in more than 1,309 outpatients worldwide and, from February, it will continue its Phase 3 clinical research with Mexican patients after obtaining permission from the Federal Commission for Protection against Health Risks (COFEPRIS).
“We are going to recruit outpatients with risk factors and symptoms,” he pointed out.
The Phase 3 clinical trial would start in February, and results are expected in April and treatment authorization will be available in May 2021.
“We are once a deadly virus. VIR-7831 is an antibody with characteristics that can prevent hospitalization or death through multiple mechanisms,” added George Scangos, Ph.D., executive director of Vir, partner in the development.
the first clinical studies conducted in the United Kingdom and San Francisco, United Statess, only warn of minor allergic reactions. It is not being supplied to minors or pregnant women.
The VIR-7831 clinical development program includes other additional trials that will possibly include severe intubated patients to boost their immune system.
The Independent Data Monitoring Committee recommended on 30 September 2020 that the study be continued in phase 3 based on a positive assessment of the safety and tolerability data of the initial phase 2 phase, “if you have Successfully, VIR-7831 has the potential to advance the outpatient treatment of covid-19 “.
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