Clinical trial NCT04382131: Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Respiratory Tract Infections
Virus
COVID
Virus Shedding
Virus Diseases
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. Participants from Scotland will be self-recruiting via web based system which will randomise in a 1:1 ratio to perform HSNIG or not.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'.
timeFrame: Maximum of 14 days
Secondary outcomes:
measure: Severity of all symptoms
timeFrame: 1-14 days or until the participant reports that they are well
measure: The length of time for individual symptoms to resolve
timeFrame: 1-14 days or until the participant reports that they are well
measure: Severity of individual symptoms
timeFrame: 1-14 days or until the participant reports that they are well
measure: Contacting healthcare (NHS 24, OOH, GP)
timeFrame: 1-14 days or until the participant reports that they are well
measure: Participants needing GP appointments
timeFrame: 1-14 days or until the participant reports that they are well
measure: Participants attending hospital
timeFrame: 1-14 days or until the participant reports that they are well
measure: Length of stay in hospital if admitted
timeFrame: 1-14 days or until the participant reports that they are well
measure: Number of participants reporting over the counter medication use
timeFrame: 1-14 days or until the participant reports that they are well
measure: Reduction in transmission to household contacts
timeFrame: 1-14 days or until the participant reports that they are well
measure: Number of participants reporting side effects of nasal irrigation
timeFrame: 1-14 days or until the participant reports that they are well
measure: Types and severity of side effects reported
timeFrame: 1-14 days or until the participant reports that they are well
measure: Cost of over the counter medication used
timeFrame: 1-14 days or until the participant reports that they are well
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: University of Edinburgh
name: Aziz Sheikh
role: PRINCIPAL_INVESTIGATOR
References: