Dr David Mummery is a member of Hammersmith and Fulham LMC and Clinical Speciality Lead for Primary Care, North West London Clinical Research Network. He writes here about why practice participation in the PANORAMIC study is important.
PANORAMIC stands for: The Platform Adaptive Trial of Novel antiviRals for eArly treatment of COVID-19 In the Community
Launching on 9 December 2021, the trial is looking at and testing antiviral medications for treating Covid-19 in the community, as promoted by the antivirals task force. Molnupiravir was recently approved by the MHRA as the first oral antiviral agent for Covid-19, and is the first antiviral agent to be trialled on the PANORAMIC platform.
The PANORAMIC trial is a huge collaboration between health agencies and academics across the UK wide trial. The focus of PANORAMIC is whether the novel agents reduce hospitalisation and mortality, and the candidate drugs have been identified by the Antiviral Task Force. There is also a virology sub-study to identify the rates of viral clearance, and the potential for development of viral resistance.
The study is necessary to build evidence regarding certain aspects of oral antiviral agents use, including:
- the effectiveness in a largely vaccinated population
- post exposure prophylaxis
Patient participation and method of study
- Participant is able and willing to provide informed consent, or their legal representative is willing to provide informed consent (for care home residents only).
- Symptoms attributable to COVID-19 started within the past 5 days and ongoing.
- A positive PCR SARS-CoV-2 test within the past 7 days. A positive lateral flow test in a symptomatic person qualifies for randomisation. Inclusion in the main analysis will be dependent on the positive PCR test (following the positive lateral flow).
- Aged ≥50 years OR aged 18-49 years with any known underlying chronic health condition considered to make them clinically vulnerable (as defined in the protocol): this includes many chronic medical conditions, so significant numbers in the 18-49 group will be eligible. A full list of pre-existing conditions is available here, these largely correspond to the ‘shielding’ criteria used earlier in the pandemic.
- Patient currently admitted to hospital.
- Previous randomisation in the PANORAMIC trial.
- Currently participating in a clinical trial of a therapeutic agent for acute COVID-19.
- Participation in an investigational COVID-19 vaccine trial within previous 28 days.
- Additional exclusions specific to each intervention arm, if any, as listed in the Intervention Specific Appendices (ISA’s) of currently open trial arms
- Oral antivirals with initial safety and efficacy data from phase 2/ smaller phase 3 trials: Molnupiravir is the first agent.
- Standard of care/usual care.
- Hospitalisation and death and secondary outcomes including: recovery, costs, safety, viral load and resistance.
The aim is to have two models for recruitment:
- PANORAMIC hubs. GP Practices are set up as regional hubs, and potential participants can be referred in by “spoke” practices. Databases are searched for potential participants. Medication is stored and dispensed by hubs. Follow up is by the study team, online, telephone and there is routine collected data extract.
- Central Recruitment: UK wide access through website, clinicians, 111, care homes and self-referral by patients themselves. The medicine will be couriered to the patient’s home and there will be a central eligibility check using the summary care record from patient and GP. Follow up is as for the Hub model.
The PANORAMIC study is running alongside the other Covid-19 monoclonal antibody (nMab) treatments that are given to highly vulnerable individuals by the Covid-19 Medicine Delivery Units (CMDUs) in hospitals. Patients in the very highly vulnerable groups are usually contacted by the CMDU if they become Covid -19 positive or can sometimes be referred by their GP via ERS, depending on your local guidance. If an individual does have an nMab treatment they can still be eligible for the PANORAMIC study, so please still inform them about the study. The CMDUs can give out Molnupiravir, but for primary care patients the way to access the Molnupiravir is through PANORAMIC.
You may have a “hub and spoke” system set up in your region, which you are aware of, or it may be easier for GPs in your area to recruit via the “central” recruitment system. In practice this is very little work for GPs and GP surgeries.
Essentially look through your lists of positive Covid-19 tests that come back to your practice each day and then text them a template text message as below, if they are eligible. The patient can then self-enrol via the PANORAMIC website, and there will be nothing else for the GP to do.
Also, you can text the message to them if you speak to or see patients that are also opportunistically eligible for the study. An example of a text message that can be sent is as below.
- Consider sending a templated text using suggested wording such as:
- “We have been informed that you have recently tested positive for COVID-19. You may be eligible to participate in a trial of anti-viral medication. If you would like to be considered for the trial you can enrol on the website panoramictrial.org. Treatment needs to be started as soon as possible after the positive test so if you wish to be part of the trial, then do not delay enrolment.”
It is hard to over-emphasise how important this study is not only for studying the effectiveness of these novel antiviral agents, in the community against Covid-19, but for possibly how the whole nature of the pandemic progresses over the next months and years, especially with the new Omicron variant that has become predominant in recent months.
It is important to also state that the antiviral medications for primary care will only be available to patients via the PANORAMIC platform.
This is a chance for primary care and primary care research to show what it can do, and how important general practice is to combating the ongoing Covid-19 pandemic.
Please, if possible, distribute information about the PANORAMIC study to your colleagues, practices, PCNs, Federations and other GP networks that you are involved in.