About the study
ELVIS COVID-19 Study Full Information
Taking part in the ELVIS COVID-19 study
COVID-19 has spread worldwide rapidly and is now a pandemic. It has been seen to cause mild to moderate illness in most people but it can cause serious illness and death, particularly in the elderly, those with long-term illness or a weakened immune system.
The ELVIS-COVID-19 study is to find out if rinsing the nose (nasal washout) and gargling with salt water (hypertonic saline) helps people with COVID-19 symptoms get better faster. Early results from a study in people with the common cold has found that doing this may help to shorten the length of time people have the cold. However, we do not know if this will be seen in those with suspected or confirmed COVID-19. This study will help us find out if nasal washouts and gargling with salty water are helpful for COVID-19 as well.
As we wait for people to have a vaccine, we need a safe and effective treatment that can be used by anyone, from the comfort of their own home. Our previous studies have shown that chloride ions supplied via salt (NaCl) have an antiviral effect that works across a number of virus types. From this data, it is suggested that nasal washout and gargling with salt water may have a role to play in lessening symptoms and the length of the COVID-19 illness.
We are asking adults in the UK with COVID-19 symptoms (who may or may not have had COVID-19 confirmed) to take part in a study where they will be asked to either carry out nasal washouts and gargle with salt water at home (salt water intervention group) or to continue to follow NHS guidance on managing COVID-19 symptoms (control group).
Participants in both groups will complete daily diaries, reporting their symptoms online until they feel well or for a maximum of 14 days, whichever happens first. We will compare the data from the group that carried out the nasal washout and gargling to the group that did not to see if there are any differences. This will then give us the answers we need to understand if nasal washout and gargling with salt water lessens the symptoms and length of COVID-19 illness and potentially roll this out to help others.
We are looking for adults (18 and over) with suspected/confirmed COVID-19 symptoms. Your symptoms must have started within the last 48 hours and should include at least one of the following:
- Recent onset of a new continuous cough
- Recent onset of a high temperature
- Recent loss of sense of smell or taste
If you have had a swab taken to confirm COVID-19 and it was positive you can still take part as long as your symptoms started within the last 48 hours and you have not been advised to go to hospital.
We can only allow one person per household to take part in the study at any one time.
You cannot take part if you:
- Are 17 or younger
- Started feeling unwell more than 48 hours ago
- Do not have access to the internet or are unable to use the internet/email
- Are unable to consent online
- Are pregnant
- Have a weakened immune system (e.g. as a result of immunosuppressant medicine or treatment, or if you have a condition that means you have a high risk of getting infections. For more information please visit the NHS website.
- Are unable to perform nasal washout and gargling with salt water
- Are taking part in another medical trial
- Do not have access to a supply of salt (you will need max 250g of salt over the 14 days)
- Have had a negative COVID-19 swab result for the present symptoms
- Have been advised to be admitted to hospital for suspected/confirmed COVID-19
- Are living in the same household as someone who is already taking part in this study.
Please read the Participant Information Sheet for more information on the study.
If you are unsure that you meet the study conditions and would like to speak to someone please contact the team
If you are interested in taking part in the study if you develop symptoms at some point in the near future you can ask to receive weekly email reminders about the study. You can stop these reminders at any time.
The study is all online and everything we ask you to do will be done at home with items you already have (salt, water and a bowl to mix and use the salt water solution).
If you decide to take part, you will be asked to sign an online consent form, however, you are free to withdraw from the study at any time, without giving a reason. Whether you take part in the study or not will have no effect on the healthcare you receive and you should always seek medical advice as normal if your symptoms get worse.
You can see a diagram of how the study works above.
When you click on the 'Sign up to participate' link you will be asked some questions to make sure you meet the conditions to take part. You will then be asked to sign a consent form online and provide your name and e-mail address so that we can keep in touch with you and send you study information.
You will receive an email to confirm that you have consented to take part in the study, with a link to the final part of the registration process.
At the final step of registration, you will be asked to fill in a short survey that will ask about your COVID-19 symptoms, your date of birth, sex, address and your GP details. These are needed so we can tell your GP that you are taking part in the study.
When you 'submit' this survey online you will then be randomly placed into one of two groups. You have 50/50 chance to be in either of these groups. You will be sent an email telling you which group you are in, with a link to a website page which will explain exactly what to do next.
Group 1: Salt water (intervention) group
If you are placed in the salt water (intervention) group, you will be asked to carry out nasal washout and gargle with salt water up to 12 times a day for 14 days or until you feel well, whichver happens first. You will be sent an email with links to instructions and videos on how to prepare and use the salt water.
Group 2: Control group
If you are placed in the control group, you will be asked to continue with your normal health care and to not do the nasal washout or gargle with salt water.
Both groups will be advised to continue to follow the UK Government advice on personal and household hygiene.
Both groups will be asked to complete online daily diaries every morning for 14 days or until you feel well, whichever happens first. Links to these diaries will be sent to you via email every day. We ask you to complete this as soon as possible each morning. You will receive an automatic e-mail reminder to complete your daily diary later in the day. If you have already completed your daily diary when the reminder arrives, please just ignore or delete it.
If you opt in to receive reminder messages by SMS you may receive an SMS message to your mobile phone as a prompt to complete a daily diary if for some reason you miss one.
The diaries will ask you about your symptoms within the last 24 hours and to compare this to the day before. Each diary should take about 10 minutes to complete.
End of illness survey
When you feel well or on day 14 (whichever happens first), you will be asked to complete another short survey that will ask a few questions on what you did during the study and if other people in your household started to have any COVID-19 symptoms.
If you have no other people in your household this will be the end of your participation in the study.
Day 14 - household survey
If you have anyone else living in your household you will be emailed again on day 14 and be asked to complete a final short survey to find out if anyone in your household started having COVID-19 symptoms after you became well.
We don't currently offer any testing opportunities, but if antibody testing becomes available, we may contact you about providing a sample for testing. This is entirely optional and you can agree to this or not when you sign up. You can also withdraw from this later if you change your mind. This will not affect the healthcare that you receive from the NHS.
If you have any questions about how the study works please contact the team
A recent pilot trial (small study to help design a larger one) showed that hypertonic saline (salt water) nasal washout and gargling reduces the length of coronavirus upper respiratory tract infection by an average of two-and-a-half days. It was found that epithelial cells (cells on the surfaces of your body, such as your skin, organs and throat lining and inside your nose) can create an antiviral effect by producing hypochlorous acid (HOCl) from chloride ions (which are in salt). HOCl is the active ingredient in bleach. Epithelial cells therefore have this natural antiviral immune mechanism to clear viral infections.
As COVID-19 is a new strain of coronavirus we do not know if nasal washout and gargling salt water will have the same effect as previously seen in other strains. If you take part in this trial and are asked to carry out the nasal washout and gargling you may or may not get a direct benefit, your symptoms may or may not get better quicker and other people in your household may or may not be protected from being infected. These are the questions we are going to look at in this study.
If you are thinking of taking part in our study, but would like a bit more information, or you’d like someone to help you as you fill in the forms, please contact the team