The British Liver Trust supports campaign to recruit people to take part in COVID-19 treatment clinical trial

Posted on: 27th January 2022

Adults over the age of 50 or with an underlying health condition, including people with liver disease, who test positive for COVID-19 are being urged to sign up for a world-first COVID-19 study which is providing life-saving antivirals to thousands of people.

Along with the government and other charities, including Kidney Care UK, Cystic Fibrosis Trust and Diabetes UK, we at the British Liver Trust are calling on at least 6,000 more participants to come forward for these cutting-edge treatments through the PANORAMIC study. This is so that expert scientists can understand more about how to deploy these treatments in the NHS more widely later in the year – including who would benefit most from receiving antiviral treatments for COVID-19.

Vanessa Hebditch, Director of Policy at the British Liver Trust said : “The introduction of new treatments for COVID-19 for the most vulnerable is an important and welcome development in the tackling of the pandemic.  People with liver disease and liver transplant recipients are among the highest risk from COVID-19 and have less immunity from vaccines so treatments are vital to reduce their risk of hospitalisation should they catch the virus.

“We urge people living with a liver condition to consider signing up for trial to protect themselves and ensure that more people can access these treatments.”

Antivirals are medicines which can be swallowed as a tablet to help treat people with COVID-19 infections to reduce the risk of hospitalisations and death. Molnupiravir, which is currently being deployed through the study, has shown to reduce this for at risk, non-hospitalised adults with mild to moderate COVID-19 by 30% - potentially saving thousands of lives once the drugs are available to the NHS.

Anyone over the age of 50 or between 18 to 49 with an underlying health condition can sign up to the study as soon as they receive a positive PCR or lateral flow test result. They need to be experiencing COVID-19 symptoms that began in the last five days to be eligible to enrol.

Professor Sir Jonathan Van-Tam, Deputy Chief Medical Officer for England, said: “If you’re eligible for PANORAMIC please give some serious consideration to taking part. This will help us decide how to use COVID-19 antiviral drugs for many years to come.”

The UK-wide study, run by the University of Oxford and launched at the start of December 2021, currently has around 4,500 trial participants signed up, but needs thousands more to sign up as soon as possible to gather the data necessary. This will ensure medical experts can learn more about the potential benefits these treatments bring to vaccinated patients, and will help the NHS to develop plans for rolling out the antivirals to further patients later this year.

It is open to anyone living in the UK who meets the following criteria:

  • Have received a PCR positive test for COVID-19 or feel unwell with symptoms of COVID-19 that started in the last five days; and
  • are aged 50 and over, or 18 to 49 years old with an underlying medical condition that can increase the risk of developing severe COVID-19.

While vaccines remain the most important first line of defence against the virus, antivirals are used after someone contracts the virus to slow it down, make symptoms less severe and complications less common.

The antiviral, molnupiravir, that is part of the PANORAMIC trial, was granted approval for use by the Medicines and Healthcare Regulatory Authority (MHRA) in November 2021, and so far no unexpected safety findings have been reported in clinical trials.

The government, through the Antivirals Taskforce, has procured 4.98 million courses of antivirals – including 2.23 million courses of molnupiravir and 2.75 million courses of PF-07321332/ritonavir.

For more information and to sign up to the trial, visit: https://www.panoramictrial.org/  

FAQs

What does participation in PANORAMIC mean?

For people who are eligible, joining the study is simple. If you have COVID-19 symptoms and receive a positive PCR or lateral flow test for COVID-19 you will be contacted by the study team or a local healthcare professional (e.g. a GP or a research nurse) to consider enrolling in the study, or you can sign up yourself at the study website. You can participate in the study regardless of where you live in the UK and we encourage people from all backgrounds and locations to consider enrolling in the study if they are eligible. This is because we want the results from the study to represent everyone in the UK, not just a certain section of the population.

  • If you are selected for the group that receives an antiviral treatment, the medicine will be sent to your home by courier from an online pharmacy. It is very important that you take the treatment every day as directed and provide the feedback requested. Around 10,600 people will need to be recruited per antiviral to generate the data needed, which we want to achieve rapidly. It is therefore crucial that as many eligible patients as possible enrol urgently onto the study as soon as they receive a positive PCR test for COVID-19. The quicker the recruitment target is met for the study, the faster the UK four nations can put in place appropriate plans to make the antivirals available outside of the national study to those who would benefit most from them.

What does the trial involve?

  • If interested, you will be asked some brief  questions online or on the telephone to check you are suitable, and provide informed consent to take part.
  • You can nominate a ‘study partner’ (family, friend, carer) to help you with the study.
  • Your GP, or a study nurse or doctor, will telephone you to make sure it is safe for you to be in the study, and to check your consent.
  • You will either receive Usual Care NHS care, or Usual Care plus an antiviral treatment, which can be delivered to you. The study will use a computer programme to decide, based on chance,  whether you will get the antiviral treatment we are testing in additional to the care you would normally receive.  This process of deciding which group you will be allocated to is completely automated and the trial team cannot alter this.
  • If allocated to an antiviral treatment plus Usual Care, you will receive a trial pack containing: an information booklet, a medication card detailing how the medication should be administered, precautions and safety guidance, medication appendix providing further information about the treatment (available prior to randomisation as part of the PIS), emergency contact card, antiviral treatment, pregnancy test (only for women of child-bearing potential)
  • Those randomised to Usual Care without the antiviral treatment will receive an information booklet via email or post.
  • Women who could possibly become pregnant  will be asked to confirm they are not pregnant (a pregnancy test will be delivered with the trial pack). If pregnant, they will be asked to return the study drug and withdraw from the trial. No one who is pregnant or breastfeeding should join the study or take a study treatment.
  • Taking part in the study will involve answering a few questions online each day for 28 days through the PANORAMIC website, or receive a phone call from the trial team on days 7, 14 and 28 to speak about your symptoms.
  • The trial team will also contact you at 3 and 6 months after you started the trial, where we will ask you about ant long-term COVID-19 symptoms.
  • You may withdraw from the trial at any stage by simply contacting the trial team.

How do you sign up?

  • You may be contacted by a member of the clinical team in a general practice that has been set up to deliver the PANORAMIC trial.  They will ask you question about your interesting of joining the study, explain the study to you, and check whether this trial is suitable for you, and help you participate in the study.
  • Or you can join the study directly by filling out the screening form linked below to check if you are eligible.

Case studies

Pippa Erskine, double lung transplant recipient who lives with Cystic Fibrosis, accessed antivirals after testing positive for COVID-19 at the start of January. Pippa said: 

“Even after three vaccines, testing positive for COVID-19 after avoiding the virus for more than 18 months was worrying. Knowing antivirals would help ease my symptoms and help prevent potential complications was a huge relief.

“With restrictions easing, it’s so important that those vulnerable to COVID-19 have the best possible chance of staying protected against the virus and, most importantly, staying out of hospital. Antivirals are essential to this.

“I’d urge anyone eligible for the trial to put themselves forward to help make antivirals more widely available, and to protect themselves and others.”

Mr Harkishan Mistry, age 58, is General Secretary of Bradford Hindu Council:

“After testing positive for COVID-19 last Monday on a lateral flow, a friend recommended I look into the antivirals trial. As I’m over 50 and was experiencing symptoms such as sore throat, headache, and achiness, I was eligible and was selected to receive the antiviral treatment by Monday afternoon.

“The whole process was so simple – a courier delivered the capsules the next morning and I began taking the course straight away. While I’m still testing positive and remain in isolation, my symptoms eased daily and I feel much better.

“I’d really recommend anyone who’s eligible for the trial to sign up – why would you not if we can help others and ease pressure on the NHS.”

Hazel, a pharmacist from Whitley Bay, got COVID-19 early in January and so signed up to the trial immediately to help find antiviral medicines to treat the virus. Hazel said: 

“I enrolled online when I got COVID-19 and the process was really simple. I got a call from a nurse right away who took me through everything and since then I’ve just had to keep a short online daily diary which takes less than a minute to do.

“The process really couldn’t be simpler, and it’s so exciting to be part of this world leading effort to find a treatment for COVID-19.

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