Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)
Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)
ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel
 group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard
 care in participants with clinically suspected or confirmed COVID-19 being managed at home.
COVID-19, a recently identified disease, has spread worldwide rapidly and is now a pandemic.
 There is no cure for it yet. Though it causes mild to moderate illness in most people, it can
 cause serious illness and death, particularly in the elderly, those with chronic illness or a
 weakened immune system.

 The ELVIS COVID-19 study is to find out if nasal washout (i.e. irrigation) 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. This trial will help us find out
 if the same treatment is helpful in improving COVID-19 symptoms and preventing the spread of
 the disease.

 After self-consenting online, participants will be randomised into one of two study groups.
 The control group will be given standard personal, household hygiene and social distancing
 advice. The intervention group will be taught using online videos how to prepare and perform
 hypertonic saline nasal irrigation and gargling (HSNIG) up to 12 times daily in addition to
 standard advice.

 Participants in both the intervention and control groups will complete an online daily diary
 first thing in the morning, which will be sent to them via an email link. The diaries will be
 completed every day until the participant reports they are well or for a maximum of 14 days
 or participant withdrawal.This study will look for participants across Scotland, who are 18
 years old or older and who are self-isolating with confirmed or suspected COVID-19, with
 symptoms that have developed no more than 48 hours before consent to the study. The study is
 conducted online and everything we ask participants to do will be done at home with items
 they will already have.
Inclusion Criteria:

 -  Adults (≥18 years)

 -  Those living within the UK

 -  Those self-isolating at home within 48 hours of the start of the illness with:

 1. Clinical symptoms suggestive of COVID-19 (i.e. those who have at least one of the
 following symptoms: recent onset of (i) new continuous cough and/or (ii) high
 temperature) and/or (iii) loss of, or change in, sense of smell or taste
 (anosmia) OR

 2. Those with virologically confirmed SARS-CoV-2 infection and clinical symptoms
 indicative of COVID-19 (as detailed in (a) above).

 -  Provision of informed consent

 Exclusion Criteria:

 -  Onset of illness>48 hours

 -  Inability to consent

 -  Pregnancy

 -  Immunosuppression

 -  Inability to perform HSNIG

 -  Those taking part in another interventional medical trial

 -  Those without access to a supply of salt

 -  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 who do not have access to email/internet

 -  Those living in a household with another person currently participating in this study