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

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ClinicalTrials.gov Identifier: NCT04382131
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Virus COVID Virus Shedding Virus Diseases Other: NaCl Solution Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'. [ Time Frame: Maximum of 14 days ]
    Time until participant reports well


Secondary Outcome Measures :
  1. Severity of all symptoms [ Time Frame: 1-14 days or until the participant reports that they are well ]
    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)

  2. The length of time for individual symptoms to resolve [ Time Frame: 1-14 days or until the participant reports that they are well ]
    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)

  3. Severity of individual symptoms [ Time Frame: 1-14 days or until the participant reports that they are well ]
    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)

  4. Contacting healthcare (NHS 24, OOH, GP) [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of participants and frequency of contacts

  5. Participants needing GP appointments [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of participants and frequency of contacts

  6. Participants attending hospital [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of participants

  7. Length of stay in hospital if admitted [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of days

  8. Number of participants reporting over the counter medication use [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of participants

  9. Reduction in transmission to household contacts [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of people within participant's household who develop symptoms

  10. Number of participants reporting side effects of nasal irrigation [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Number of participants in intervention arm reporting side effects

  11. Types and severity of side effects reported [ Time Frame: 1-14 days or until the participant reports that they are well ]
    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'

  12. Cost of over the counter medication used [ Time Frame: 1-14 days or until the participant reports that they are well ]
    Estimated cost requested when participant states over the counter medication used


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382131


Contacts
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Contact: Aziz Sheikh 01316514151 aziz.sheikh@ed.ac.uk
Contact: Emma Ward 01316519910 ELVIS-COVID19@ed.ac.uk

Locations
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United Kingdom
NHS Lothian Recruiting
Edinburgh, United Kingdom
Contact: Kenny Scott         
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Aziz Sheikh University of Edinburgh
More Information
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT04382131    
Other Study ID Numbers: AC20042
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Virus Diseases
Infection
Respiratory Tract Diseases