Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Upper Respiratory Tract Infections, Virus, COVID, Virus Shedding, Virus Diseases

Intervention / Treatment
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* Other: NaCl Solution


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic saline nasal irrigation and gargling<br>Participants in the intervention arm will be asked to perform hypertonic saline nasal irrigation and gargling up to 12 times daily for a maximum of 14 days or until they report that they feel well. | Other: NaCl Solution<br>* NaCl Solution prepared by participants at home using water and salt<br>|
| No Intervention: Standard Care<br>Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'. | Time until participant reports well | Maximum of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of all symptoms | Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe) | 1-14 days or until the participant reports that they are well | 
| The length of time for individual symptoms to resolve | Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe) | 1-14 days or until the participant reports that they are well | 
| Severity of individual symptoms | Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe) | 1-14 days or until the participant reports that they are well | 
| Contacting healthcare (NHS 24, OOH, GP) | Number of participants and frequency of contacts | 1-14 days or until the participant reports that they are well | 
| Participants needing GP appointments | Number of participants and frequency of contacts | 1-14 days or until the participant reports that they are well | 
| Participants attending hospital | Number of participants | 1-14 days or until the participant reports that they are well | 
| Length of stay in hospital if admitted | Number of days | 1-14 days or until the participant reports that they are well | 
| Number of participants reporting over the counter medication use | Number of participants | 1-14 days or until the participant reports that they are well | 
| Reduction in transmission to household contacts | Number of people within participant's household who develop symptoms | 1-14 days or until the participant reports that they are well | 
| Number of participants reporting side effects of nasal irrigation | Number of participants in intervention arm reporting side effects | 1-14 days or until the participant reports that they are well | 
| Types and severity of side effects reported | Participants asked if they have experienced common side effects or other and to rate the severity on a 7 point scale of 'Did not have this side effect' to 'severe' | 1-14 days or until the participant reports that they are well | 
| Cost of over the counter medication used | Estimated cost requested when participant states over the counter medication used | 1-14 days or until the participant reports that they are well |