COVID medicine delivery unit service

What are they?

Neutralising monoclonal antibodies 

Neutralising monoclonal antibodies (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 first line option along with Paxlovid (see below)

Antiviral

Antiviral medications inhibit viral replication and prevent progression of infection.

• Paxlovid (PF-07321332: nirmatrelvir + ritonavir) = first line option(along with nMAB above) (symptom onset within 5 days)
• Remdesivir second line antiviral (symptom onset within 7 days)
• Molnupiravir third line antiviral (symptom onset within 5 days)

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. Other patients may be offered oral medication to treat their COVID-19 diagnosis.

 

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 at Home.

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)

Patients are not eligible if they meet any of:

• require hospitalisation or a new need for supplemental oxygen
• children less than 40 kg
• Children less than 12 years of age
• known hypersensitivity reaction to the active substance or any of the excipients

Determined by an independent advisory group commissioned by the Department of Health and Social Care:

• al 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 to 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
    • 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 (such as 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 (such as aplastic anaemia or paroxysmal nocturnal haemoglobinuria) receiving B-cell depleting systemic treatment (such as 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 or 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 or 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 or autoimmune polyendocrinopathy, candidiasis, ectodermal dystrophy (APECED syndrome)
  • primary immunodeficiency associated with impaired type I interferon signalling
  • x-linked agammaglobulinaemia (and other primary agammaglobulinaemia)
  • any patient with a secondary immunodeficiency receiving, or eligible for, immunoglobulin replacement therapy
• HIV or AIDS:
  • patients with high levels of immune suppression, have uncontrolled or untreated HIV (high viral load) or present acutely with an AIDS defining diagnosis
  • on treatment for HIV with CD4 with less than 350 cells/mm3 and stable on HIV treatment or CD4 more than 350 cells/ mm3 and additional risk factors (such as 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

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.

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

Via e-RS

Infectious diseases CMDU-CFT. 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 and allergies.
• Include medical condition making patient eligible for CMDU.
• Make sure patient contact details are included (a telephone number is essential).

Weekend referrals

Adults

Over the weekend period the CMDU service is not available. The service is then reinstated on a Monday morning with. Therefore, patients referred over the weekend are all screened on a Monday morning.

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 have not 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.

The panoramic study is looking at the use of oral anti-viral treatment for patients with recently acquired COVID infection. Read information on the panoramic study looking at oral anti-viral treatment for COVID patients for further details and how patients can sign up.

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

Drug	Hospital admission rate: control	Hospital admission rate: treatment	Number needed to treat	Relative risk reduction
Sotrovimab	6%	1.0%	20	85%
Molnupiravir	9.7%	6.8%	35	30%
Paxlovid	7%	0.8%	16	89%

Summaries of product characteristics:

1. SPC/Xevudy
2. SPC/Lagevrio
3. SPC/Paxlovid, read the Paxloid patient information leaflet 

A national letter has been sent to high-risk patients for preparation.

An email, SMS and text has been sent to high-risk patients following positive COVID test were sent out from Monday 20 December 2021.

Learning events

It is important that any near miss or incident is reported on the relevent Trust incident system.  

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 COVID-19 yellow card scheme.