What will happen if I take part?
If you are happy to take part in this study, a researcher will ask you some simple questions and check your medical history to confirm that you are eligible. If you are eligible, you will be asked to sign and date a consent form for the study. We will then ask you some questions about your medical history and to check you are not already taking any drugs (medications) that Azithromycin should not be taken with and some questions about your health. These questions should take you no more than 10 minutes to answer.
There are no additional tests that you will have as a result of agreeing to take part in this study with one exception. At the time of this information being written, people who come to hospital, where doctors decide not to admit are not routinely having a COVID-19 swab taken to confirm or deny whether the symptoms are as a result of COVID-19, unless there is a reason such as being an essential worker and the need to know whether you are able to return to front line duties. We ask that you agree to having this COVID-19 swab, this is like a big cotton wool bud that is placed into your nose and moved around to remove some cells. Please note that we will not be able to tell you the results of this swab – as not all swabs will be immediately processed due to resources.
As part of standard NHS care, you will have an ECG (an electrical tracing of your heart), blood tests and a chest x-ray, as part of your COVID-19 assessment – we will ask for your permission to review and record these results for the study team.
You will then be randomly allocated to one of the study groups by a computer, i.e. allocation is by chance. You will have an equal chance of being allocated to either group, like the toss of a coin. The computer would put you either into:
- The Azithromycin group – where we would ask you to take Azithromycin for 14 days. We would ask you to take the tablets (or liquid suspension) once a day, about the same time each day – with or without food as you feel able to.
- The current standard care group – where we would not give you any Azithromycin to take.
There is a 50% chance that you will be in either group. For both groups, the doctors will give you the latest current advice – which may include rest, pain relief and advice on when it might be appropriate to return to hospital if needed.
The random allocation is important because this way, we can test the different treatments fairly and nobody can influence into which group you are placed. Your healthcare and research teams will not be able to affect which group you are put into and you will not be able to choose. You should note, that is not in NHS guidelines for you to be given Azithromycin for the symptoms of COVID-19, so if you decide not to participate in this trial, or if you agree and are not allocated the Azithromycin, the team looking after you will not be able to give you a prescription for Azithromycin, as this is the reason for this study to see if the drug does cause a difference.
At some sites, if time and resources permit and you are well enough, they may also ask you if in addition to the above COVID-19 swab whether you would be prepared to give some blood for some extra tests.
These tests are only for the purposes of this study and the results will not be available to your clinical care team and your GP. The samples are to help researchers understand the impact COVID-19 and any drugs you might be given are having on your body. If you agree to give these samples – we would ask you to give up to 40mls of blood (this is the equivalent of 3 tablespoons) and allow the researchers to take a sample of your nose fluid. This would involve a small brush or sponge being inserted and gently rubbed inside the nostril. This takes a few seconds to do and may cause sneezing and/or coughing. Occasionally there may be a little discomfort and rarely minor bleeding. A small piece of paper will be inserted into the nostril to collect nasal fluid (nose). All of these samples are entirely optional – and you can decide to give all or none of them. If you do agree to give samples – if you were to be admitted to hospital within 28 days of randomisation – we might also take 32ml of blood (this is the equivalent of just over 2 tablespoons) and another collection of some nasal fluid if you agree on your consent for to this.
NOTE – TO TAKE PART IN THE STUDY YOU DO NOT NEED TO AGREE TO GIVE ANY SAMPLES – OTHER THAN A COVID-19 NOSE SWAB – EVERYTHING ELSE IS ENTIRELY OPTIONAL.
RISKS & BENEFITS
For those that take part in the study, your NHS care will not change. Your time in the assessment unit you are being seen in will not change – no additional procedures will be undertaken for the purposes of this study.
The information from this study we hope will answer the question of whether Azithromycin is a drug that should be given to or not given to patients who come to hospitals or GP surgeries who do not need to be admitted to hospital. We cannot promise the study will help you directly, but the information we get has the potential to be of benefit to those who start to show COVID-19 symptoms.
People sometimes feel uncomfortable answering certain questions about their health, or may be unable to answer. If you feel uncomfortable at any point, then you do not have to answer the questions.