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

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04382131
• Other study ID #: AC20042
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: July 2020
• Source: University of Edinburgh
• Contact: Aziz Sheikh
• Phone: 01316514151
• Email: aziz.sheikh[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Respiratory Tract Infections
• Upper Respiratory Tract Infections
• Virus
• Virus Diseases
• Virus Shedding

Intervention

Other:
• NaCl Solution
NaCl Solution prepared by participants at home using water and salt

Locations

Country	Name	City	State
United Kingdom	NHS Lothian	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Participants needing GP appointments	Number of participants and frequency of contacts	1-14 days or until the participant reports that they are well
Secondary	Participants attending hospital	Number of participants	1-14 days or until the participant reports that they are well
Secondary	Length of stay in hospital if admitted	Number of days	1-14 days or until the participant reports that they are well
Secondary	Number of participants reporting over the counter medication use	Number of participants	1-14 days or until the participant reports that they are well
Secondary	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
Secondary	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
Secondary	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
Secondary	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