Upper Respiratory Tract InfectionsNCT04382131
Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)
A study testing NaCl Solution in people with Upper Respiratory Tract Infections and Virus, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Respiratory Tract Infections, Virus, COVID
- What is being tested?
- NaCl Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2020to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Onset of illness>48 hours
- Inability to consent
- Pregnancy
- Immunosuppression
- Inability to perform HSNIG
- Those taking part in another interventional medical trial
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Upper Respiratory Tract Infections, Virus, COVID, Virus Shedding, Virus Diseases
- Being tested
- NaCl Solution
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl SolutionOther
NaCl Solution prepared by participants at home using water and salt
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline nasal irrigation and gargling | Experimental | 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. Receives: Other: NaCl Solution |
| Standard Care | No intervention | Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resolution of Symptoms as Defined by the Single Question 'How Unwell do You Feel Today'.
Time until participant reports well
Measured: Maximum of 14 days
Secondary outcomes (12)
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). Participants asked 'How unwell do you feel today?' on this scale
Measured: 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)
Measured: 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)
Measured: 1-14 days or until the participant reports that they are well
Contacting Healthcare (NHS 24, OOH, GP)
Number of participants who contacted healthcare services during the study period
Measured: 1-14 days or until the participant reports that they are well
Participants Needing GP Appointments
Number of participants and frequency of contacts
Measured: 1-14 days or until the participant reports that they are well
Participants Attending Hospital
Number of participants
Measured: 1-14 days or until the participant reports that they are well
Length of Stay in Hospital if Admitted
Number of days
Measured: 1-14 days or until the participant reports that they are well
Number of Participants Reporting Over the Counter Medication Use
Number of participants
Measured: 1-14 days or until the participant reports that they are well
Change in Transmission to Household Contacts
Number of participants who reported transmission to other members of their household the study period
Measured: 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
Measured: 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'
Measured: 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
Measured: 1-14 days or until the participant reports that they are well
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start23 Jun 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: Halted prematurely due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aziz Sheikh, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382131
- Sponsor's protocol ID
- AC20042
- Status last verified
- Mar 2026
- First submitted
- 8 May 2020
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04382131
- Acronym / sponsor ID
- AC20042
- Conditions
- Upper Respiratory Tract Infections, Virus, COVID, Virus Shedding, Virus Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely due to slow recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline nasal irrigation and gargling | Experimental | Other: NaCl SolutionParticipants 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. |
| Standard Care | No intervention | –Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥18 years)
- Those living within the UK
- Those self-isolating at home within 48 hours of the start of the illness with:
- Provision of informed consent
Key exclusion criteria (11 listed)
- Onset of illness>48 hours
- Inability to consent
- Pregnancy
- Immunosuppression
- Inability to perform HSNIG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaCl SolutionNaCl Solution prepared by participants at home using water and salt | Other | Hypertonic saline nasal irrigation and gargling |
Primary outcome
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
12 secondary outcomes
Severity of All Symptoms
Time frame: 1-14 days or until the participant reports that they are well
The Length of Time for Individual Symptoms to Resolve
Time frame: 1-14 days or until the participant reports that they are well
Severity of Individual Symptoms
Time frame: 1-14 days or until the participant reports that they are well
Contacting Healthcare (NHS 24, OOH, GP)
Time frame: 1-14 days or until the participant reports that they are well
Participants Needing GP Appointments
Time frame: 1-14 days or until the participant reports that they are well
Participants Attending Hospital
Time frame: 1-14 days or until the participant reports that they are well
Length of Stay in Hospital if Admitted
Time frame: 1-14 days or until the participant reports that they are well
Number of Participants Reporting Over the Counter Medication Use
Time frame: 1-14 days or until the participant reports that they are well
Change in Transmission to Household Contacts
Time frame: 1-14 days or until the participant reports that they are well
Number of Participants Reporting Side Effects of Nasal Irrigation
Time frame: 1-14 days or until the participant reports that they are well
Types and Severity of Side Effects Reported
Time frame: 1-14 days or until the participant reports that they are well
Cost of Over the Counter Medication Used
Time frame: 1-14 days or until the participant reports that they are well
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziz Sheikh principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaCl Solution in people with Upper Respiratory Tract Infections and Virus, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of Symptoms as Defined by the Single Question 'How Unwell do You Feel Today'. (time frame: Maximum of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.