Antibody treatment given to Trump could be vital in fighting Covid-19 this winter in UK 

The antibody treatment used to treat Donald Trump for Covid-19 last October is set to become a vital part of the UK’s Covid-19 strategy this winter. The treatment became available on the UK’s health service in September, and a phase 11/111 trial conducted by Roche has recently shown that the drug reduces viral load within 7 days.

When Donald Trump was confirmed to have tested positive for Covid-19 last October, the medical team of then-US President made a decision which raised numerous eyebrows among doctors, scientists and in the media.

Rather than prescribing one of the more prevalent emergency treatments, such as the steroid dexamethasone or remdesivir to treat the President, Trump’s medical team opted to give him an experimental antibody therapy named Ronapreve (or REGEN-COV in the U.S.), then newly-developed by the U.S. biotechnology company Regeneron Pharmaceuticals with Swiss healthcare company Roche.

In what became his most-liked Tweet ever, garnering more than 1.5 million likes, Trump announced that he would be beginning the “quarantine and recovery process immediately.” In mid-October, just two weeks after Trump tested positive, his physician Dr. Sean Conley released a message stating that Trump “is no longer considered a transmission risk to others.”

Within days, Trump had returned to his relentless campaign trail much to the astonishment of onlookers who were keen to know the source of his phenomenal recovery.

“I walked in, I didn’t feel good. A short 24 hours later, I was feeling great, I wanted to get out of the hospital, and that’s what I want for everybody. I want everybody to be given the same treatment as your President because I feel great,” former President Trump said after receiving the treatment.

The 75-year-old’s speedy recovery left many asking what treatment did the president receive in 10 days to go from requiring supplemental oxygen to no longer being infectious, according to his physician.

 

RONAPREVE AUTHORISED FOR USE IN THE UK

Fast-forward 12 months and now Ronapreve has become the first neutralising antibody medicine specifically designed to treat Covid-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.

The UK follows Japan, who were the first country to approve Ronapreve as a treatment for Covid-19 in July.
In a statement on the 20th July, the pharmaceutical giant said that the antibody combination had already been authorised for emergency or temporary use in a number of countries and regions, including the European Union, the United States, India, Switzerland and Canada.

In Europe, Ronapreve is currently not authorised in patients who are hospitalised due to COVID-19 infection. Earlier this year, the European Medicines Agency (EMA)’s medicine committee (CHMP) issued a scientific opinion supporting the use of Ronapreve as a treatment option for non-hospitalised patients with confirmed COVID-19.
Now that it has been made available for patients on the NHS, it is expected to be a vital component in the UK’s approach to fighting Covid-19 this winter.

Its rollout is initially targeted at those who have not mounted an antibody response against Covid-19 who are either aged 50 or over, or are aged 12 to 49 and are considered to be immunocompromised.

The Department for Health and Social Care in the UK stated that the treatment has the potential to benefit thousands of COVID patients.

“We have secured a brand new treatment for our most vulnerable patients in hospitals across the UK and I am thrilled it will be saving lives from as early as next week,” Health Secretary Sajid Javid proclaimed mid September.

“The UK is leading the world in identifying and rolling out life-saving medicines, particularly for COVID-19, and we will continue our vital work to find the best treatments available to save lives and protect the NHS,” he added.

From the 23rd September, Trusts in Northern Ireland became able to access Ronapreve for eligible patients with guidance issued to clinicians to support them to prescribe the treatment as soon as possible. The NI Executive described Ronapreve as “a new innovative treatment” that combines two Neutralising monoclonal antibodies (nMABs) Casirivimab and Imdevimab.

Northern Ireland’s Chief Medical Officer Professor Sir Michael McBride said:

“The availability of Ronapreve will help us significantly as we continue to move through this pandemic. It will initially be targeted at those in hospital aged 50 and over, or are aged 12 to 49 and are considered to be immunocompromised, and have not mounted an antibody response against COVID-19. This will include individuals who are immunocompromised, such as patients with certain cancer or autoimmune diseases.”

The drug, which is given either by injection or infusion, consists of two artificially generated antibodies – known as monoclonal antibodies – which are designed to imitate the body’s natural immune response by binding to sites on the Sars-CoV-2 preventing it from invading cells and replicating.

This approach works in a similar way to convalescent plasma therapy, an emergency treatment which was used early on in the pandemic, in which antibodies from the blood of people who had recovered from the virus were given to other patients to boost their immunity.

However, monoclonal antibodies are more effective and have fewer side effects since they are designed to bind solely to the coronavirus rather than other cells in the body.

 

PHASE II/III TRIAL

Last week, Roche announced positive results from a Phase II/III study investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19, complimenting previous findings.

The trial has evidenced that Ronapreve significantly reduced viral load within 7 days of treatment in seronegative patients and those who required low-flow or no supplemental oxygen.

The European Pharmaceutical Review (EPR) reported Thursday that: “The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in seronegative patients and who required low-flow or no supplemental oxygen.

“The Phase II/III, randomised, double-blind, placebo-controlled trial evaluated Ronapreve in hospitalised adult patients with COVID-19. Of the 1,197 patients included in the efficacy analysis, 530 entered the trial with no supplemental oxygen and 667 were on low-flow oxygen. The safety analysis included results from all patients in the efficacy analysis plus additional patients from earlier stages of the clinical program who were on low-flow oxygen at baseline.

“Patients were randomised 1:1:1 to receive a one-time infusion of Ronapreve 8,000mg, Ronapreve 2,400mg or placebo. All patients entering the trial were hospitalised with laboratory-confirmed COVID-19, and all received other background standard-of-care as required including corticosteroids (75 percent) and remdesivir (55 percent).”

On average, those included in the efficacy analysis had experienced Covid-19 symptoms for 6 days before entering the trial, and 43 percent were seronegative. In the trial, no serious or dose-dependent safety signals in Ronapreve treated patients were observed. In a safety analysis involving 2,007 patients, serious adverse events occured in 21 per cent of Ronapreve patients and 26 per cent of placebo patients.

The effectiveness and safety of the drug has been studied across multiple Phase III clinical trials carried out in non-hospitalised and hospitalised Covid-19 patients, and in the preventative setting.

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