Thank you to everybody for the work that you are doing, these are incredibly tough times and the last 20 months have been unparalleled in our careers as health care professionals. What is coming in the next few months may be even more challenging, therefore the UKKA and renal community COVID-19 Leadership Group has put together this practical summary as we move into this wave of the pandemic. Thank you to all those who are contributing their expertise and time in so many ways.
The information here can be viewed on the UKKA website, and regular updates will be made to the site.
Recent changes and updates since 14th December
Omicron numbers are rising rapidly in London with other areas of the country likely to follow.
Many renal units have developed excellent local guidance but others may also find it helpful to refer to the check list generated by UKKA during the first phase of the pandemic which has now been updated and is available here.
OpenSAFELY data confirming the continuing vulnerability of renal patients to poor outcomes even after two COVID-19 vaccine doses is now published and available here.
The following renal patients who were given a third primary COVID-19 vaccine dose are now entitled to a booster COVID-19 vaccine dose three months after their third primary:
- Transplant patients and those patients whose transplants have failed but who have been on immunosuppression within the last 6 months.
- Nephrology patients receiving equivalent immunosuppression for autoimmune disease.
The central recording system for COVID-19 vaccinations is currently unable to distinguish third primary vaccines which are therefore labelled as boosters. Additionally, a block has been placed in the national digital systems, which prevents anyone using the online line booking systems, to book a booster dose, if your data show you have already received 3 doses in total.
Some eligible renal patients are therefore having problems accessing their fourth vaccine dose. Please could units provide eligible patients with a letter highlighting their entitlement to a fourth COVID-19 vaccine to ensure access – an example of such a letter modified from a template from Imperial is provided here.
The following non-hospitalised renal patients are now entitled to extended therapies if they test positive in the community for COVID-19:
- Renal transplant recipients
- Non-transplant recipients who have received a comparable level of immunosuppression
- Patients with CKD stage 4 or 5 without immunosuppression
Our understanding is that these patients will be identified centrally using lists of clinically extremely vulnerable (CEV) patients which have previously been created. Such patients will be sent a letter explaining their entitlement, and providing them with a PCR testing kit. If they tests positive, they will then be contacted by the local COVID-19 Medicines Delivery Unit (CMDU) to offer treatment.
Many CEV lists are now out of date and although inclusion of the CKD 4 patients in the list of those entitled to extended therapies is welcome, these patients are not currently identified in CEV lists.
Units may therefore wish to:
- Contact their local COVID-19 Medicines Delivery Unit to ensure community cases reported directly to the Renal units can also be given access to newer therapies.
- Provide their local COVID-19 Medicines Delivery Unit with an updated list of all renal CEV patients including those in CKD 4.
- Provide letters to those who have become clinically extremely vulnerable within the last year and to those with CKD 4 to ensure they are aware of their eligibility for newer therapies.
As Omicron becomes the dominant variant sotrovimab (Xevudy) will be available for use as the first line treatment for non-hospitalised patients. Antiviral treatment may be offered to patients in this category where an nMAB is contraindicated or treatment with an nMAB is not possible.
It is possible that renal units may be asked to administer this monoclonal antibody within their dialysis units.
The criteria for eligible non-hospitalised patients will comprise:
- SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) testing within the last 5 days AND
- Onset of symptoms of COVID-19 within the last 5 days AND
- The patient is a member of the ‘highest’ risk group as set out in the policy (all renal transplant recipients, non-transplant patients receiving a comparable level of immunosuppression, all patients (including dialysis patients) with an eGFR less than 30 ml/min/1.73m2)
The following links are for centrally generated letters to patients and clinicians explaining how to access extended therapies:
Letter to patients: Important information about new treatments for coronavirus
Letter to clinicians: Contacting your patients about new COVID-19 treatments
Many renal patients are understandably frightened and confused by the current situation. Many are unaware of their entitlement to extended therapies - our charity partners have therefor prepared excellent information – please see the links at the end of this document.
Renal units are likely to be contacted by a large number of patients looking for clarification – please alert all clinical and administrative staff in your unit to this possibility and ensure that all staff have a basic understanding or know how to refer onto to those with expertise. Please see later detailed section about advice to patients.
Background
The Omicron COVID-19 variant is a major concern. At the time of writing the number of individuals with the variant in the UK is increasing exponentially. Omicron is becoming the dominant variant in the UK and there will be a sustained wave of COVID-19.
We anticipate that clinical services will again have to care for large numbers of patients with COVID-19. It is not yet known if Omicron causes as severe disease as the delta variant.
Vaccination
Current JCVI guidance is that immunocompromised people can receive a third primary dose now, as they may not have made a full response to the first two doses. Three months after the third dose they can receive a booster dose which will be their fourth. People with kidney disease but not on immunosuppressants can only receive three doses at the moment. We have again appealed this guidance (see below).
We know that individuals with kidney disease who are unvaccinated, particularly those receiving kidney replacement therapy, have a very high risk of death if infected with COVID-19. We know that vaccination is highly protective against COVID-19 and that third/booster vaccination provides substantial additional protection.
We therefore need to continue to encourage those who are vaccine hesitant to reconsider vaccination.
Vaccination stimulates antibody production less effectively in dialysis and transplant patients, and the antibodies generated are less effective at neutralising Omicron than other variants. However, there is encouraging evidence that three doses of vaccine offer substantial protection against severe disease and death, even amongst individuals with kidney disease. Vaccines to provide enhanced protection against Omicron are in development.
Whilst vaccination is protective for individuals with kidney disease, even double vaccinated individuals with kidney disease may be at far higher risk of serious outcomes when infected with COVID-19 than individuals without kidney disease. Despite this, many patients who are eligible for a third vaccination are still reporting that they have not been vaccinated. What patients are reporting is confirmed by the data: people with CKD are no more likely to have had a third dose than those without, and 25% of people aged 16-69 with CKD are yet to have a third dose.
This further reinforces the importance of ensuring that all patients are able to access third/booster vaccines.
Based on evolving data that will soon be in the public domain, and what is known from studies of antibody levels, the UKKA have asked JCVI to recommend that all patients requiring dialysis and all patients with CKD stage 4 and 5 not requiring dialysis, and who do not currently fulfil criteria for a third primary vaccine, have their booster vaccine re-designated as a third vaccine. We had previously asked JCVI to recommend third vaccines for dialysis patients and have now extended this to those other groups. We have provided JCVI with strong evidence.
If JCVI supports this recommendation, patients in these groups who have received a third vaccine would then become eligible for a fourth vaccine (a booster vaccine).
Influenza vaccine
More people are likely to get flu this winter as fewer people will have built up natural immunity to it during the COVID-19 pandemic. Data show that it is safe to have the COVID-19 vaccine and flu jab at the same time. People with kidney disease are also at high risk from flu and eligible for these vaccines now.
Treatments
As you know, therapies for COVID-19 are expanding. Your hospitals will have treatment pathways in place for patients who are hospitalised with COVID-19. Please see the comment below in respect of Ronapreve, which does not appear effective against Omicron. It is therefore important to confirm with your local laboratory that they can identify the COVID variant for all infections in a timely manner as this will affect recommended treatment pathways.
For non-hospitalised patients, the NHS has now published a commissioning policy for monoclonal antibodies and antivirals, which becomes effective on 16th December. The policy focuses on high-risk patients who may derive greater benefit than standard risk patients.
The eligibility criteria comprise a positive PCR test within the last 72 hours, onset of symptoms of COVID-19 within the last 7 days, and a member of a highest risk group.
The highest risk group includes individuals with kidney disease comprising renal transplant recipients; non-transplant recipients who have received a comparable level of immunosuppression; and patients with CKD stage 4 or 5 without immunosuppression.
This information may change, but our current understanding is that in England each integrated care system (ICS) will provide a COVID Medicines Delivery Unit (CMDU) to ensure provision of treatment. It is anticipated that specialist services will work with their CMDU to support the set- up. We have no clarity yet for the devolved nations.
One major challenge is that Ronapreve is not effective against Omicron. Sotrovimab appears effective against Omicron but is not yet available. The first availability of Sotrovimab for kidney patients will be for transplant patients and patients receiving immunosuppression in the PROTECT_V platform trial STOP-IT study. It is anticipated that this study will open for recruitment in the next few weeks. We do not yet have information on when Sotrovimab will become available in mainstream practice.
A 5-day course of Molnupiravir is recommended for patients within 5 days of onset of symptoms if Ronapreve is contraindicated or ‘not recommended’; the guidance acknowledges that Ronapreve may prove ineffective against Omicron, so we anticipate that Molnupiravir will become, by default, first line treatment.
It is not yet clear whether Molnupiravir will be prescribed in primary care, secondary care, or by CMDUs.
The recommended use of Molnupiravir in advanced CKD goes beyond the existing trial data (patients with eGFR<30 ml/min/1.73 m2 were excluded from the MOVe-OUT trial), but the drug is not excreted in urine, and the potential benefits are considered to outweigh the risks: however, it is anticipated that urgent pharmacokinetic and mandated post-authorisation surveillance studies will be announced.
In-centre haemodialysis (ICHD)
The KQuIP COVID-19 haemodialysis patient safety working group has made recommendations on best practice to minimise the risk of transmission which can be accessed here.
There is variation in implementation of these guidelines across the UK. The group also recommend:
- Ensuring that all dialysis patients have now had their booster vaccines
- Patients should continue to wear a fluid resistant surgical facemask type 11R
- Maintain social distancing of >2 metres
- Provision of COVID-safe transport
- Weekly SARS-CoV-2 PCR test for all patients to facilitate early detection and isolation of asymptomatic cases.
NHS renal units should work collaboratively with their private dialysis providers to facilitate the above actions.
Communication with patients
There has been coordination across the renal community between professional and patient groups to ensure consistent communication. Patient communication can be accessed here. People with kidney disease are being alerted to the fact that they remain at much higher risk than most other people in the general population, particularly if they have advanced CKD or are on immunosuppression, even after two doses of vaccine.
Advice is changing on a day-to-day basis and this is confusing for patients. Outside of reminding patients of current statutory guidance on mask wearing, social distancing, working from home, we recommend the following principles:
1. Based on previous waves, recommendations on limiting social mixing have been made relatively late and this may have exposed more high-risk patients. Consequently, a patient may want to make personalised decisions now based on their individualised risk and there may be a range of options open to them.
Measures which may help them include:
- limiting the number of people they mix with over the festive season
- ensuring that all their household contacts have received three doses of COVID-19 vaccines as soon as possible
- asking any social contacts to perform a lateral flow test before meeting
- undertaking regular PCR tests themselves to ensure any infections are identified early, so that they may be given access to additional therapies where indicated
2. Emphasise the central importance of vaccination in protecting patients and help ensure that individual patients can access third and booster vaccines
3. Ensure that patients within the high-risk groups identified for prioritisation for treatment of COVID-19 are aware that community treatments will be available to them for community acquired COVID-19.
4. Speak to their employers about risk assessments and mitigations if they are unable to work from home.
5. Remind patients of the importance of having a flu jab and other protections such as handwashing, mask wearing, avoiding busy places, and keeping windows open when mixing with others, if possible. The importance of social distancing and (where relevant) working from home should be emphasised.
6. Patients may be feeling particularly anxious with new uncertainties so directing them to support services locally or online, such as Mindfulness, Kidney Care UK or the National Kidney Federation
For more information:
UK Kidney Association COVID-19 information for professionals and patients
Kidney Care UK COVID-19 information for patients
The National Kidney Federation COVID-19 information for patients