COVID medicine delivery unit (CMDU) service

Treatments are available for those the NHS considers at highest risk of developing severe COVID-19. 

The test to treatment pathway for the CMDU service will now be based primarily on lateral flow device (LFD) tests, supplied by UKSHA to the highest-risk patients which should be used if an individual eligible for COVID treatments experiences COVID symptoms.

Digitally identifiable, eligible patients will receive a letter from NHS England and NHS Improvement to inform them of the change and remind them about treatments with an initial supply of 7 LFD tests in the post.

Patients who have not been identified digitally or captured on national datasets, may be written to separately by their consultant. The national letter below may be utilised.

Anyone who does not receive their test kit, or needs further test kits, should order them or by calling 119. 

It remains essential that patients report their test results (negative or positive)  or by calling 119 to assist in digital identification, timely access to treatment and wider surveillance. Results of privately bought tests cannot be registered.

Detailed information for patients 

All relevant documentation can be found here 

What are they?

WHAT are they?

Neutralising Monoclonal Antibodies (nMABs)

nMABS are synthetic monoclonal antibodies that bind to the spike protein of the Covid virus, which prevents entry into the host cell and replication.

The nMAB which will be in use:

  • Xevudy (sotrovimab) - symptom onset within 5 days 1stline option (along with Paxlovid -see below)

Antiviral

Antiviral medications inhibit viral replication and prevent progression of infection.

  • Paxlovid (PF-07321332: nirmatrelvir + ritonavir) = 1st line option(along with nMAB above) (symptom onset within 5 days)
  • Remdesivir 2nd line antiviral (symptom onset within 7 days)
  • Molnupiravir 3rd line antiviral (symptom onset within 5 days)

Where will they be used?

A CMDU Service has been set up within Camborne and Redruth Community Hospital.

A clinical assessment team associated with the CDMU, will screen and review patients for their suitability for specialist COVID treatments. They will then refer patients to the appropriate pharmacist for further screening. Once this has been actioned, some patients will be offered the opportunity to attend a clinic at Camborne Redruth Hospital, where they can administer the nMAB via an intravenous infusion for the treatment of COVID-19 if most appropriate choice for the patient.

Eligibility

Patients will be identified as high risk at the point of a positive Lateral Flow or PCR test and be sent an email and/or SMS text to inform them of this.

If they are eligible for treatment, the admin team at the CMDU will arrange for the patient to come in for the infusion, or a course of antivirals will be sent to the patient.

Patient who are assessed as not eligible will be informed of this by the CMDU triage service and offered remote monitoring via Oximetry@home.

Eligibility criteria

Non-hospitalised patients are eligible if:

  • Lateral Flow or PCR positive covid test result
  • Symptomatic AND onset of symptoms of COVID-19 within last 5 to 7 days.
  • AND a member of a highest risk group (see below).

Eligibility exclusion criteria

Patients are not eligible if they meet any of:

  • Require hospitalisation or a new need for supplemental oxygen.
  • Children <40kg
  • Children <12 years of age
  • Known hypersensitivity reaction to the active substance or any of the excipients

Eligible conditions (highest risk group)

Determined by an independent advisory group commissioned by the Dept of Health and Social Care. This list is copied from the commissioning policy:

  • All patients with Down’s syndrome 
  • Patients with a solid cancer
    • Active metastatic cancer and active solid cancers (at any stage)
    • Patients receiving chemotherapy within the last 3 months
    • Patients receiving group B or C chemotherapy 3-12 months prior (see appendix 3 of interim clinical commissioning policy)
    • Patients receiving radiotherapy within the last 6 months
  • Patients with a haematological diseases and stem cell transplant recipients
    • Allogeneic haematopoietic stem cell transplant (HSCT) recipients in the last 12 months or active graft vs host disease (GVHD) regardless of time from transplant (including HSCT for non-malignant diseases)
    • Autologous HSCT recipients in the last 12 months (including HSCT for non-malignant diseases)
    • Individuals with haematological malignancies who have
      • received chimaeric antigen receptor (CAR)-T cell therapy in the last 24 months, or
      • radiotherapy in the last 6 months
    • Individuals with haematological malignancies receiving systemic anti-cancer treatment (SACT) within the last 12 months except patients with chronic phase chronic myeloid leukaemia (CML) in molecular response or first or second line tyrosine kinase inhibitors (TKI)
    • All patients with myeloma (excluding MGUS) or chronic B-cell lymphoproliferative disorders (e.g. chronic lymphocytic leukaemia, follicular lymphoma) or myelodysplastic syndrome (MDS) who do not fit the criteria above
    • All patients with sickle cell disease
    • Individuals with non-malignant haematological disorder (e.g. aplastic anaemia or paroxysmal nocturnal haemoglobinuria) receiving B-cell depleting systemic treatment (e.g. anti-CD20, anti-thymocyte globulin [ATG] and alemtzumab) within the last 12 months
  • Patients with renal disease
    • Renal transplant recipients (including those with failed transplants within the past 12 months), particularly those who:
      • Received B cell depleting therapy within the past 12 months (including alemtuzumab, rituximab [anti-CD20], anti-thymocyte globulin)
      • Have an additional substantial risk factor which would in isolation make them eligible for nMABs or oral antivirals
      • Not been vaccinated prior to transplantation
    • Non-transplant patients who have received a comparable level of immunosuppression
    • Patients with chronic kidney stage (CKD) 4 or 5 (an eGFR less than 30 ml/min/1.73m2) without immunosuppression
  • Patients with liver disease
    • Patients with cirrhosis Child’s-Pugh class B and C (decompensated liver disease).
    • Patients with a liver transplant
    • Liver patients on immune suppressive therapy (including patients with and without liver cirrhosis)
    • Patients with cirrhosis Child’s-Pugh class A who are not on immune suppressive therapy (compensated liver disease)
  • Patients with immune mediated inflammatory disorders (IMID)
    • IMID treated with rituximab or other B cell depleting therapy in the last 12 months
    • IMID with active/unstable disease on corticosteroids, cyclophosphamide, tacrolimus, cyclosporin or mycophenolate.
    • IMID with stable disease on either corticosteroids, cyclophosphamide, tacrolimus, cyclosporin or mycophenolate.
    • IMID patients with active/unstable disease including those on biological monotherapy and on combination biologicals with thiopurine or methotrexate
  • Immune deficiencies
    • Common variable immunodeficiency (CVID)
    • Undefined primary antibody deficiency on immunoglobulin (or eligible for Ig)
    • Hyper-IgM syndromes
    • Good’s syndrome (thymoma plus B-cell deficiency)
    • Severe Combined Immunodeficiency (SCID)
    • Autoimmune polyglandular syndromes/autoimmune polyendocrinopathy, candidiasis, ectodermal dystrophy (APECED syndrome)
    • Primary immunodeficiency associated with impaired type I interferon signalling
    • X-linked agammaglobulinaemia (and other primary agammaglobulinaemias)
    • Any patient with a secondary immunodeficiency receiving, or eligible for, immunoglobulin replacement therapy
  • HIV/AIDS
    • Patients with high levels of immune suppression, have uncontrolled/untreated HIV (high viral load) or present acutely with an AIDS defining diagnosis
    • On treatment for HIV with CD4 < 350 cells/mm3 and stable on HIV treatment or CD4 > 350 cells/ mm3 and additional risk factors (e.g. age, diabetes, obesity, cardiovascular, liver or renal disease, homeless, those with alcohol-dependence)
  • Solid organ transplant recipients
    • All recipients of solid organ transplants not otherwise specified above
  • Rare neurological conditions
    • Multiple sclerosis
    • Motor neurone disease
    • Myasthenia gravis
    • Huntington’s disease

Interactions

Interactions

Further detail on interactions for nMABs or antivirals with other medication(s) can be found in the individual SPC.

Further information can also be found on the University of Liverpool COVID-19 drug interaction checker

Referrals

You may come across some high-risk patients who have slipped through the net, or if the local CMDU has not contacted the patient within 24 hours of receipt of the result, they will be asked to contact either the GP practice or NHS 111 or specialist hospital clinician. You can refer to the Covid Medicines Delivery Unit (CMDU) via the routes below:

The CMDU service referral form has now been added to EMIS. Please send via eRS or email as below.  A Word version of the referral form is also available.

For the minority of clinicians unable to refer patients via the EMIS referral form e.g. specialist hospital clinicians please use the Word version or email as detailed below.

Via e-RS

Infectious diseases - BNSSG Covid-19 (nMABS) Delivery Unit (CMDU). Send these referrals direct and not via the Referral Service

  • Send with the date of the most recent positive Lateral Flow or PCR test please remind patient to register lateral flow test result or call 119
  • Date of symptoms start (if known)
  • List of all patient medications/allergies
  • Include medical condition making patient eligible for CMDU
  • Make sure patient contact details are included (a telephone number is essential)
  • Hospital and ward if in Mental Health hospital

Weekend Referrals

NHS111, Out of Hours and colleagues working within BNSSG

Adults

Please note over the weekend period the CMDU service is not avalible. The service is then reinstated on a Monday morning with. Therefore, patients referred over the weekend are all screened on a Monday morning. Please can you advise patients that may present over the weekend to expect a phone call from a clinician on the Monday and to contact their regular GP if they haven’t heard from a clinician by the Monday afternoon. This is applicable to adult patients only.  

Mental Capacity

In rare cases where patients lack capacity it may be necessary for the service to seek help from the patient’s GP. The time critical nature of the treatment means decisions need to be made on the day or within 24 hours for the majority of cases. The CMDU clinician may contact the practice – initially by phone and then by sending details to the email address the practice provides – with details of the eligibility criteria and treatments available. They will ask the GP whether the patient meets the criteria and if so – on balance – whether treatment is likely to be in the patients bests interest. For example, would traveling to hospital for a day case infusion be unduly distressing, would they accept an IV cannula, would they take a large capsule twice a day.

Screeners will make every effort to make this decision independently and the patient’s GPs will be asked to support only in exceptional circumstances.

Panoramic clinical study

The Panoramic study is looking at the use of oral anti-viral treatment for patients with recently acquired COVID infection. Please see the attached Information on Panoramic Study looking at oral anti-viral treatment for COVID patients for further details and how patients can sign up.

Additional information

What are the side effects? 

For a list of side effects please refer to individual summary of product characteristics below

Effectiveness of the nMABs or antivirals

Effectiveness of the nMABs or antivirals

Drug

 

Hospital admission rate – control

Hospital admission rate – treatment

Number Needed to Treat

Relative risk reduction

Sotrovimab1

6%

1.0%

20

 85%

Molnupiravir2

9.7%

6.8%

35

 30%

Paxlovid3

7%

0.8%

16

89%

 

Summaries of Product Characteristics:

  1. SPC/Xevudy
  2. SPC/Lagevrio
  3. SPC/Paxlovid  Patient information leaflet Paxlovid 

National Letter sent to high-risk patients for preparation

Email/SMS/text sent to high-risk patients following positive COVID test from Monday 20 Dec 2021

Learning events

It is important that any near miss or incident is reported on Datix

As these medications are MHRA black triangle drugs, all adverse reactions occurring in individuals of any age after administration should be reported to the MHRA using the specific Coronavirus Yellow Card Scheme. https://coronavirus-yellowcard.mhra.gov.uk/