The protocol will be conducted at the National Health Institutes of Mexico Candidate treatment VIR-7831 phase 3 which has the potential to neutralize the virus, kill infected cells and make one protective barrier in the lungs of patients at high risk of complications from covid-19 due to diabetes, hypertension, obesity, and other diseases, or are older than 55 years.
Sigfrido Rangel, medical director of GSK Mexico, explained MILLENNIUM than the monoclonal antibody against SARS-CoV-2 it will prevent patients from being complicated by chronic and degenerative diseases controlled or uncontrolled, and achieve the degree of intubation due to the 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 and attaching to T cells and all those around the lungs,” he explained.
How does it work?
He biotech is injected into the vein for 60 to 90 minutes (time an antibiotic is given) and immediately blocks the S protein from SARS-CoV-2 and other receptors that damage the lungs. In addition, the monoclonal antibody has the special feature of increasing the patient’s immune response, so that it can fight with its white blood cells those cells that have already been infected.
The monoclonal antibody, developed by GSK and Vir company, is provided to people who have been in contact with a positive person or who already have the first symptoms of getting Covid-19, including the new variant detected in the UK.
It must be give within a maximum of 10 days after the first symptoms thereby avoiding the damage caused by the coronavirus by reducing respiratory capacity, satiety levels, inflammation and lung infections, collapsing the rest of the vital organs.
He explained that the effect is not that of a vaccine designed to generate long-lasting immunity. It is a treatment, such as that given in each consultation, with the advantage that the person receiving the injection by the intravenous route immediately concentrates the active substance in the lungs to block the covid-19 virus, even for other pathogens. of the coronavirus family. .
It also prevents the virus from multiplying and infecting other cells of patients at high risk due to diabetes, hypertension, obesity, kidney disease, regardless of whether they are well controlled or not.
“In those 10 days, the virus continues to multiply, so it is essential not to exceed that limit to have a protective response,” he said.
The treatment would be helpful to patients like the president Andrés Manuel López Obrador, who showed signs and symptoms yesterday, has hypertension, although under control, “with a single dose they will achieve that protective effect.”
When do the tests start?
Research on VIR-7831 (also known as GSK4182136) has been conducted in more than 1.30 outpatient participants worldwide and, Starting in February, the Phase 3 clinical trial will continue with Mexican patients after obtaining permission from the Federal Commission for the Protection against Sanitary Risks (Cofepris).
“We are going to recruit outpatients with risk factors and symptoms,” he said.
The Phase 3 clinical trial was expected to commence in February with results expected in April and the treatment approval in May 2021.
‘We are facing a deadly virus. VIR-7831 is an antibody with features that can prevent hospitalization or death through multiple mechanisms, ”added George Scangos, Ph.D., Vir CEO, development partner.
The first clinical studies conducted in the United Kingdom and San Francisco, United Statesyes, they only warn of minor allergic reactions. It is not given to minors or pregnant women.
The VIR-7831 clinical development program includes additional studies involving potentially critically ill intubated patients to boost their immune systems.
The Independent Data Surveillance Commission recommended on September 30, 2020 that the investigation proceed to Phase 3 based on a positive assessment of the early phase 2 safety and tolerability data, “If successful, the VIR -7831 has the potential to progress. to book the outpatient treatment of Covid-19 ”.
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The fact is, you don’t have to worry.
The fact is, you don’t have to worry.
The fact is, you don’t have to worry.