ELVIS COVID-19 [COVID-19]
Research type
Research Study
Full title
Hypertonic saline nasal irrigation and gargling with hypertonic saline for suspected or confirmed COVID-19: pragmatic web-based Bayesian adaptive randomised controlled trial (ELVIS COVID-19)
IRAS ID
282692
Contact name
Aziz Sheikh
Contact email
Sponsor organisation
The University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
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.\nThe 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.\nAfter 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.\nParticipants 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.\nThis 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.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0056
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion