The disadvantage in taking part in this study may be the risk of having the side-effects from Evusheld and/or the COVID-19 booster vaccine.
Evusheld has been given to 10,000 participants, a number of which had compromised immune systems, as part of other studies and is considered to be safe. Similar to other monoclonal antibodies and to other medications, there is a risk that the drug may have side effects. These may be mild or severe and may occur within hours or days after the injection. Symptoms may include joint pain and swelling, fainting, dizziness, hives or rash. It may also cause redness, itching, tenderness, or a rash where the injection is given.
As with all the COVID-19 vaccines, there is a there is a small risk of rare serious side effects, such as an allergic reaction. These may be related to the immune system or to the nervous system. Severe allergic reactions to vaccines and mono-clonal antibodies are rare (approximately 1 per million vaccine doses, unknown in Evusheld).
Serious allergic reactions may include anaphylaxis. Anaphylaxis is a life-threatening allergic reaction, which would be diagnosed by a doctor. The initial symptoms may include difficulty in breathing, swelling of the lips, a drop in blood pressure and a rash. After receiving the study drug you will be monitored for any immediate signs or symptoms of an allergic reaction. Without immediate medical treatment this condition can be fatal. In case of this unlikely event, medication for treating allergic reactions is available and the researchers are appropriately trained in the management of anaphylaxis.
Serious cardiac adverse events have happened, but were not common, in people who received Evusheld and also in people who did not receive Evusheld in the clinical trial studying pre-exposure prophylaxis for prevention of COVID-19. In people with risk factors for cardiac events (including a history of heart attack), more people who received Evusheld experienced serious cardiac events than people who did not receive Evusheld. It is not known if these events are related to Evusheld or underlying medical conditions.
Participants may also experience low platelets (cells that help the blood to clot) which can lead to bleeding in the mouth, gums, bruising, nose bleeds, and pinpoint red spots on the skin.
These are not all the possible side effects of Evusheld. Not a lot of people have been given Evusheld. Evusheld is still being studied so it is possible that all of the risks are not known at this time.
The potential impact of Evusheld on other medicinal products (including any COVID-19 vaccine) is not known. There is a possibility that receiving the study drug prior to vaccination may result in the COVID-19 vaccine being less effective up to nine months to one year or more or may cause the vaccine to have other currently unknown side effects. Studies thus far have indicated that it is unlikely that Evusheld will impact on the COVID-19 vaccines.
Participants will be asked to attend the clinic a total of seven times (including the baseline visit) throughout the study so that we can assess how they are and collect blood samples. This may increase the risk of contracting COVID infection. The clinical care team will do their best to limit the exposure to potential infections during the hospital visits.
Obtaining blood samples may sometimes cause pain at the site where the blood is drawn from bruising, occasional light-headedness, and fainting, which is relatively rare.
You should not donate blood during the trial or take part in other studies that involve blood sampling or the administration of drugs or vaccines, including trials testing other preventive interventions for COVID-19.
Participation in this study means that, unless the study team specifically advise otherwise, you will not be able to receive any of the approved NHS COVID-19 vaccines for three months after receiving your booster vaccine on this study as this may affect the results of the study.
Because the effects of Evusheld on an unborn child or infant are not yet known, pregnant or breast feeding women are not eligible for the trial. If you are able to become pregnant you must be willing to practice continuous effective contraception during the study for up to three months following your dose of Evusheld. Your study doctor can discuss acceptable birth control methods with you. It is suggested, that male participants should use a condom from day 1 and continue through 3 months after receiving the study drug.
If you are male, by signing this consent form, you agree to avoid getting your partner pregnant and you agree not to donate sperm while you are in the study and for up to three months after the last dose of Evusheld.
If during the treatment period, or for up to three months after Evusheld, you learn that you are pregnant or your female partner becomes pregnant, you must tell your study doctor immediately. During your study visits, the study doctor may ask you for more information about any pregnancy to see if there are any effects of the study medication on unborn children. If you are male and report a pregnancy of your female partner, the study doctor will ask to speak to your partner, if she agrees to this.