EVUSHELD PHASE II. A unique opportunity

[BooBoo39]

I have recently attended Clatterbridge Hospital in Liverpool to participate in the latest Evusheld trial. The trial will take one year to complete and will require further visits throughout that time.

Evusheld does not depend on a healthy immune system to generate protective immunity. And while approved by the MHRA, the UK Government delayed buying the prophylactic monoclonal antibody treatment EVUSHELD saying that it was unsure about its effectiveness against Omicron.

The RAPID-PROTECTION study is investigating COVID-19 vaccinations in combination with Evusheld.

Evusheld is a combination of two long-acting antibodies that bind to the spike protein on the outside of the SARS-CoV2 virus and prevents the virus from entering human cells.

Although Evusheld is known to be effective against the Omicron variant, it is not yet known how long this protection lasts.

This Phase II clinical trial will assess Evusheld when combined with the Pfizer BioNTech and Moderna COVID-19 vaccines in immunocompromised individuals.

The RAPID-PROTECTION study will test the level of immune protection that the treatment offers to vulnerable patients, and whether this protection can be improved by a repeat COVID-19 vaccination.

Emerging real world data and scientific modelling suggests that increasing the dose of Evusheld from 300mg to 600mg should give further protection against COVID-19 as it continues to evolve. The higher dose of Evusheld (600mg) was found to be well tolerated and comparable to the lower dose of Evusheld (300mg). This study will help improve our understanding of Evusheld and how well it works against emerging COVID-19 variants in immunocompromised people.

Whilst at Clatterbridge I had benchmark bloods taken prior to my treatment a full medical and then received four separate injections to combine the antibodies to make up my 600mg Evusheld.

I felt no stiffness/soreness after the injections and have suffered no side effects. I now await my allocated Covid vaccine of Pfizer or Moderna in two weeks.

It is comforting to know that the scientists who brought us Oxford AstraZeneca and set free the majority of the world are still working tirelessly to set free the forgotten immunocompromised.

I feel very lucky to be accepted onto this trial as I firmly believe Evusheld will be a lifeline to the thousands of people like myself still shielding from coronavirus.

Thank you for reading and i will update further as the trial continues

[Varp]

Great news you were accepted for this. Will look forward to your future updates.

Take care

[BooBoo39 Volunteer in reply to Varp]

Thank you

[GPAC]

Sounds like an interesting study. I wonder how they will know if it is the Evusheld or the vaccine that is working to produce neutralizing antibodies to covid? Look forward to your updates and good luck.

[BooBoo39 Volunteer in reply to GPAC]

Hi GPAC

Thank you for your interest

Throughout the trial i will be returning to Liverpool from Scotland to be regularly assessed medically. This will include bloods that will be shared with several labs and the Oxford Labs.

At every stage the bloods are looked at to assess the T-cells in preventing Covid and how the bodies anti-bodies respond at every stage of the trial. Including the life of Evusheld and its reaction to a covid vaccine.

It is my understanding that the two monoclonal antibodies tixagevimab and cilgavimab when combined (Evusheld)work together to create a deterrent/prophylactic to Covid so stopping the virus entering the bodies cells. By doing this the bodies natural antibodies are not required to create an immune response. The efficacy from previous research shows that Evusheld is around 77% first analysis to 83% mean analysis in reducing the risk of developing symptomatic Covid compared to placebo over the previous research time period.

The two monoclonal antibodies are already succesfully used in the treatment of known Covid cases to lessen the severity of viral burden and limited inflammation in the lungs across all variants reducing the need for intensive care and ventilators.

Evusheld has the potential to provide long-lasting protection to vulnerable populations such as the immunocompromised who are unable to mount an adequate response to a covid vaccine. This is an important step forward in ongoing efforts to realise important preventative measures for people at higher risk of hospitalization and complications from Covid.

They also want to understand if the effect of the preventative/ pre-exposure prophylactic 'Evusheld' is enhanced by a Covid vaccine or vice versa and/or hopefully extend their effective life span.

Thus moving forward making it a more beneficial financial proposition for a Government to purchase and roll out to the immunosuppressed.

[GPAC in reply to BooBoo39]

I think this is a great study and I am glad you taking part in it. However, are you certain about the statement below, especially that you mention lessening viral burden and limiting inflammation in the lungs across ALL variants?

"The two monoclonal antibodies are already succesfully used in the treatment of known Covid cases to lessen the severity of viral burden and limited inflammation in the lungs across all variants reducing the need for intensive care and ventilators."

If the above is true why would the FDA remove the EUA for evusheld? See here: fda.gov/drugs/drug-safety-a...

And this reference from the FDA from the above link. "FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5."

Maybe the FDA is waiting for the additional data from the study that you are enrolled in?

If you have some info on this that would clarify the above I would be really interested in seeing it, if you can share.

Good luck with the study, and good for you for getting involved in this very important research.

[BooBoo39 Volunteer in reply to GPAC]

Dear GPAC

Thank you for your kind wishes for my involvement in the trial .

As you have mentioned EUA ( Emergency Use Authorization) and FDA ( US Food & Drug Administration) in your post i am assuming that you are presently residing in the US.

I would like to emphasize the trial currently taking place in the UK is using EVUSHELD II .

Currently i believe the FDA in the US has withdrawn its licence for the use of EVUSHELD I because of its lessening effectiveness to some new variants.

However concerning your question re the quote below

"The two monoclonal antibodies are already succesfully used in the treatment of known Covid cases to lessen the severity of viral burden and limited inflammation in the lungs across all variants reducing the need for intensive care and ventilators."

This statement as it reads concerns the proven studies in the UK of the two monoclonal antibodies in their treatment as anti-virals on actual happening Covid cases. As an anti-viral treatment it is still very effective.

As mentioned before Evusheld is a Pre-Exposure Prophylaxis Treatment to prevent Covid .

The trial currently taking place in the UK using EVUSHELD II and its combined effect with selected Covid Vaccines to increase its efficacy and longevity to new & existing variants

Obviously licensing from one country to another has different guidelines and you will have read possibly on other posts how disappointing it was for the UK when Evusheld I was rolled out to 32 countries but not passed for general use by our licensing body (NICE) only for private use costing in some instances in excess of £3000.

From it's release to the rest of the world 18 months have lapsed in this time and without the benefit of Evusheld the immunosuppressed of the UK are still fully or partly shielding as they were in March 2020 as this frightening deadly Covid pandemic began.

Hopefully at the end of this trial there will be a successful conclusion as regards UK general licensing towards Evusheld II.

I cannot comment as regards the FDA in the US or other licensing bodies as regards their decision at that time.

Just to say that a Pre-Exposure Prophylaxis drug cannot come soon enough for the forgotten cohort of immunosuppressed in the UK.

[GPAC in reply to BooBoo39]

Thanks for clarifying that you are in the evusheld 2.0 trial, I must have missed that part somewhere, but all the more interesting. I am in Canada and we did have access to evusheld 1.0, 300 and then 600, but it was painfully slow to rollout through the Canadian bureaucracy! I am also aware of UK evusheld situation which is disappointing to say the least. I really hope that the UK will get it right with evusheld 2.0, and that your contribution leads to that ultimate success in the UK, but for the rest of us too! I will be following your updates with interest.

[BooBoo39 Volunteer in reply to GPAC]

Hi GPAC

Yes let's hope we get a positive outcome at the end of this trial. It would make such a difference to everyone physically and mentally. I do not think the majority of people understand the self imposed restrictions affecting the immunosuppressed and how it affects the daily lives of not just the individual but everyone they are close to as well.

[Poshcards]

Good to know somebody is still looking into this drug x

[BooBoo39 Volunteer in reply to Poshcards]

I know its good news and brilliant the medics and scientists are fighting for a return to some normality for us. But they also need us guys to keep 'banging on doors' and keep the battle cry strong. Because the rest of the population may think we're the forgotten cohort and feel they have the upper hand because we cannot actively gather in great crowds to protest but we can shout as loud as the next person and write to MP's , the press, radio let's use media in a good way. we need to put pressure on the system. This is our battle and it's quite clear no one is going to fight it for us.