The full eligibility criteria for the study can be found via the following link:
Patients with a diagnosis of haematological malignancies and receiving one the following treatments:
a. Cohort 1a - Patients receiving active therapy with immunosuppressive or immunomodulating agents including:
ImiD drugs (thalidomide, lenalidomide, pomalidomide or equivalent) in myeloma and other plasma cell dyscrasias
b. Cohort 1b - Patients receiving aggressive therapy expected to cause temporary ablation of immune function including:
Patients with kidney disease who fall into one of the following groups:
Patients with liver cirrhosis, autoimmune liver disease and liver transplant.
If you are eligible for the study, you will be asked to attend clinic to receive Evusheld. To take part in the study, you will need to:
If you decide to take part in the study, you will be asked to sign the consent form and your General Practitioner will be notified of your participation. The treatment you are receiving for your current health condition will not be affected by your participation in the study and will continue as intended by your treating doctor. Your study doctor will monitor your safety and well-being throughout the study.
If you agree to take part in this study, you must come to the hospital at the times agreed with your study doctor as the information we will collect at these appointments are critical for answering the question of the study.
You will be asked to attend the clinic to provide blood samples 7 times over the space of one year to check the levels of Evusheld and to examine your immune responses against COVID-19. You will be compensated for your time.
Telephone call from your treating team who will ask you about how you are feeling and if you have had any side effects.
You will be asked to attend the clinic for follow up visits so that we can check how you are, to check on your symptoms and to provide further blood samples. These will be scheduled at56, 112, 180, 273 and 364 days post injection to check the levels of Evusheld and to examine your immune responses against COVID-19. At these visits, you may be asked to complete a questionnaire and a PCR swab for COVID-19.
If you become symptomatic for COVID-19 during the study you must take a lateral flow test and self-report the result to the study team. In this eventuality, you will be asked questions about the severity of your symptoms and will be required to take a nasal swab at home, and return this in the freepost packaging to the laboratory for PCR testing. The materials and instructions for collecting, packaging and posting swabs will be provided to you as part of the study.
You are encouraged to keep a supply of lateral flow tests at home whilst you are on the study. We advise you to regularly order via the NHS website: www.gov.uk/order-coronavirus-rapid-lateral-flow-tests
You will be asked to complete questionnaires at four timepoints throughout the study (Days 0, 112, 180 and 364 days after the Evusheld injection). The questionnaire should take about 10-15 minutes to complete.
The questionnaires ask about your household, behaviour changes due to the COVID-19 pandemic and your general health and wellbeing. Your unique trial number will be collected, in addition to your partial date of birth (mm/yyyy), when completing the questionnaires to link your trial data. The collection of partial date of birth on these questionnaires is as an extra cross check to ensure that the correct data is being collected for the correct participant and will not be used for any other reason.