COVID Clinical Trial
Official title:
Hypertonic Saline Nasal Irrigation and Gargling for Suspected or Confirmed COVID-19: Pragmatic Web-based Bayesian Adaptive Randomised Controlled Trial (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.
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