The Health Secretary urged the public to sign-up to world-first study for antivirals if they test positive for COVID-19 … reports Asian Lite News. Recruitment drive backed by charities including Kidney Care UK, Cystic Fibrosis Trust, Diabetes UK and the British Liver Trust as antivirals help protect most vulnerable from hospital
At least 6,000 more participants needed as soon as possible so the life-saving treatments can be rolled out more widely. People can sign up here: panoramictrial.org/
Adults over the age of 50 or with an underlying health condition 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.
The government and leading charities, including Kidney Care UK, Cystic Fibrosis Trust, Diabetes UK and 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.
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.
Health and Social Care Secretary Sajid Javid said: “The vaccines are critical as a first line of defence, but antivirals form a vital part of our approach as we learn to live with COVID by preventing the most vulnerable from being hospitalised.
“If you’re eligible, please step forward for the PANORAMIC trial and play your part in a vital mission – helping us to learn more about medicines which could save thousands of lives.”
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.
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.”
Eddie Gray, Chair of the Antivirals Taskforce, said: “Antivirals are a hugely important addition to our response to COVID-19 and we have secured access to two important products for NHS patients.
“Getting people enrolled onto this study is vital, not just in protecting the most vulnerable now, but in ensuring we can deploy these medicines more widely as soon as possible.”
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.”
David Ramsden, chief executive of Cystic Fibrosis Trust, said: “It is vital for that we continue to focus on the development and evaluation of new treatments for COVID-19. This is a really important study and we would encourage all eligible people with cystic fibrosis to get involved.”
Fiona Loud, Policy Director at Kidney Care UK, said: “We welcome the development and provision of antiviral treatments for people who are vulnerable to COVID-19. This trial is one of the ways to make them more widely available so we would like to encourage everyone who is eligible, including those with kidney disease, to take part in this study. While we continue to encourage people to take up the offer of vaccinations, antiviral treatments are going to be a vital tool to give more protection to people who are most at risk from COVID-19, including those with kidney disease.”
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.”
For more information and to sign up to the trial, visit: https://www.panoramictrial.org/
Background on antivirals
- The two antivirals we have secured are molnupiravir (also called Lagevrio) made by Merck, Sharp and Dohme (MSD), and PF-07321332 (also called Paxlovid) made by Pfizer, which is Pfizer’s novel antiviral taken alongside another drug, ritonavir. Both molnupiravir and PF-07321332 have completed clinical trials whereby participants were randomly selected to receive either the antiviral or a placebo. Results from molnupiravir trials show a roughly 30% relative reduction in the rate of hospitalisation in those who received the antiviral compared to the placebo. Results from a company-run clinical trial of PF-07321332 also look positive, suggesting an 89% reduction in the risk of hospitalisation compared to placebo.
- Further details on the deployment of PF-07321332 will be set out in due course.
- Based on trial data showing that molnupiravir is safe and effective, the medicines regulator, the MHRA has recently licensed molnupiravir for treatment of COVID-19. The MHRA would not approve a treatment unless it meets their high standards of quality, safety and effectiveness. As molnupiravir has been approved by the MHRA, it is the first antiviral treatment for COVID-19 to be made available to UK patients. PF-07321332 is not currently approved by the MHRA for use in the UK.
Eligibility for PANORAMIC
The national study is open to people who meet all the following criteria:
- Have received a PCR or lateral flow positive test for COVID-19.
- Feel unwell with symptoms of COVID-19 that started in the last 5 days; and
- Are aged 50+, or 18-49 years old with an underlying medical condition that can increase chance of having severe COVID-19:
- Chronic respiratory disease (including chronic obstructive pulmonary disease (COPD), cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication)
- Chronic heart or vascular disease
- Chronic kidney disease
- Chronic liver disease
- Chronic neurological disease (including dementia, stroke, epilepsy)
- Severe and profound learning disability
- Down’s syndrome
- Diabetes mellitus
- Immunosuppression due to disease or treatment (e.g. sickle cell, HIV, cancer, chemotherapy)
- Solid organ, bone marrow, or stem cell transplant recipients
- Morbid obesity (BMI >35)
- Severe mental illness
- Care home resident
- Considered by recruiting clinician to be clinically vulnerable
Description of what participation in PANORAMIC means
- 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.