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

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.

Study Overview

• Status: Unknown
• Conditions: Virus Diseases; COVID; Upper Respiratory Tract Infections; Virus; Virus Shedding
• Intervention / Treatment: Other: NaCl Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 405
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aziz Sheikh; Phone Number: 01316514151; Email: aziz.sheikh@ed.ac.uk
• Study Contact Backup: Name: Emma Ward; Phone Number: 01316519910; Email: ELVIS-COVID19@ed.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • NHS Lothian
    • Contact: Kenny Scott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hypertonic saline nasal irrigation and gargling; 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; NaCl Solution prepared by participants at home using water and salt
NO_INTERVENTION: Standard Care; 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?

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

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Aziz Sheikh, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2020
• Primary Completion (ANTICIPATED): October 31, 2020
• Study Completion (ANTICIPATED): October 31, 2020

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (ACTUAL): May 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Virus Diseases; Respiratory Tract Infections
• Other Study ID Numbers: AC20042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No