About the study
ELVIS COVID-19 Study Full Information
COVID-19 has spread worldwide radily and is now a pandemic. There is no cure for it yet. 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 prolonged illness or a weakened immune system.
The ELVIS-COVID-19 study is to find out if nasal washout and gargling with salt water (hypertonic saline) helps individuals with COVID-19 get better faster. Preliminary data from those with the common cold has found that nasal washouts and gargling with salty water may be helpful in reducing the length of the illness. We do not however know if this same benefit will also 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 in COVID-19.
In the absence of a suitable vaccine, we need a safe and effective treatment that can be used globally. Our previous studies have shown that chloride ions supplied via salt (NaCl) has 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 reducing symptoms and the duration of the COVID-19 illness.
We are asking adults in the UK with COVID-19 symptoms or a confirmed case of COVID-19 to take part in a randomised controlled trial in which they will be asked to either perform nasal washout and gargling with salt water at home or to continue to follow NHS guidance on managing COVID-19 symptoms. Participants in both groups will complete daily diaries documenting their symptoms online until they feel well or for a maximum of 14 days. We will compare the data from the group that performed the nasal washout and gargling to the group that did not to see if there are any differences. This will then give us answers we need to understand if this reduces the symptoms and duration of COVID-19 and potentially roll this out to help others.
We are looking for adults (18 and over) that are self-isolating at home due to 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 also 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 fulfil any of the below:
- You are 17 or younger
- Onset of illness is more than 48 hours
- No access to the internet or unable to use the internet/email
- Unable to consent online
- 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.
- Unable to perform nasal washout and gargling with salty water
- Those taking part in another medical trial
- Those without access to a supply of salt (you will need max 250g of salt over the 14 days)
- Those who have had a negative COVID-19 swab result for the present symptoms
- Those with suspected/confirmed COVID-19 in whom hospital admission is recommended
- Those living in a household with another person currently participating in this study
Please read the Participant Information Sheet for more information on the study.
The study is all online and everything we ask you to do will be done at home with items you already have at home.
If you decide to take part, you will be asked to electronically sign a consent form, however, you are free to withdraw at any time, without giving a reason. Whether you take part or not, it will have no effect on the healthcare you receive and you should always seek medical advice as normal if your symptoms get worse.
When you click to register for the study, you will be asked a few questions to make sure you fit the criteria to take part. You will then be asked to sign a consent form online to then be randomly assigned into one of two groups. You have 50/50 chance to be in either of these groups and the allocation is random. You will be sent emails with further information detailing which group you have been allocated to. If you are in the intervention group, you will be asked to perform the nasal washout and gargling with salty water up to 12 times a day for 14 days or until you feel well and you will be sent an email including links to instructions and videos on how to prepare and perform this. If you are in the control group, you will be asked to continue with your normal health care and to not do the nasal washout or gargling.
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. Links to these diaries will be sent to you via email every morning. We ask you to complete this as soon as possible in the morning. The diaries will ask you about your symptoms within the last 24 hours and to compare this to the day before. Each diary should not take longer than 10 minutes to complete.
When you feel well or on day 14 (whichever comes first), you will be asked to complete another form which 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 became well earlier, on day 14, you will be asked if anyone in your household started having COVID-19 symptoms after you became well.
If antibody testing becomes available, we may contact you about providing a sample for testing. This is optional and you can consent to this or not during the consent process. You can also withdraw from this later if you would like without affecting your healthcare. As the situation surrounding antibody testing is unclear at the moment we will give you more detail on this when we can.
A recent pilot trial (small study to help design a larger one) indicated that hypertonic saline (salty water) nasal washout and gargling reduces the duration 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 salty 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 investigate through this study.