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Halted prematurely due to slow recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Care | No Intervention | Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaCl Solution | Other | NaCl Solution prepared by participants at home using water and salt |
|
| 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 |
| 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). Participants asked 'How unwell do you feel today?' on this scale | 1-14 days or until the participant reports that they are well |
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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:
Provision of informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aziz Sheikh | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Lothian | Edinburgh | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. NaCl Solution: NaCl Solution prepared by participants at home using water and salt |
| FG001 | Standard Care | Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. NaCl Solution: NaCl Solution prepared by participants at home using water and salt |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Resolution of Symptoms as Defined by the Single Question 'How Unwell do You Feel Today'. | Time until participant reports well | information provided by 8 HSNIG and 3 standard care | Posted | Mean | Standard Deviation | days | Maximum of 14 days |
|
study start up to 14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. NaCl Solution: NaCl Solution prepared by participants at home using water and salt |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling tired, Shortness of breath, General feeling of discomfort or unease (malaise), Nausea,Chills | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Evans | Edinburgh Clinical Research Facility | - | e.evans@ed.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2020 | Feb 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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. Participants from Scotland will be self-recruiting via web based system which will randomise in a 1:1 ratio to perform HSNIG or not.
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| 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 who contacted healthcare services during the study period | 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 |
| Change in Transmission to Household Contacts | Number of participants who reported transmission to other members of their household the study period | 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 |
| Standard Care |
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | incomplete information provided by participants | Mean | Standard Deviation | meters |
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| Weight | incomplete information provided by participants | Mean | Standard Deviation | kg |
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| Smoke | incomplete information provided by participants | Count of Participants | Participants |
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| 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). Participants asked 'How unwell do you feel today?' on this scale | Information provided by 8 HSNIG and 3 standard care Data collected until participants answer '0' then question not asked again on later days. | Posted | Mean | Standard Deviation | units on a scale | 1-14 days or until the participant reports that they are well |
|
|
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| 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) | Not Posted | 1-14 days or until the participant reports that they are well | Participants |
| 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) | Not Posted | 1-14 days or until the participant reports that they are well | Participants |
| Secondary | Contacting Healthcare (NHS 24, OOH, GP) | Number of participants who contacted healthcare services during the study period | Posted | Count of Participants | Participants | 1-14 days or until the participant reports that they are well |
|
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| Secondary | Participants Needing GP Appointments | Number of participants and frequency of contacts | Posted | Count of Participants | Participants | 1-14 days or until the participant reports that they are well |
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| Secondary | Participants Attending Hospital | Number of participants | Posted | Count of Participants | Participants | 1-14 days or until the participant reports that they are well |
|
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| Secondary | Length of Stay in Hospital if Admitted | Number of days | Not Posted | 1-14 days or until the participant reports that they are well | Participants |
| Secondary | Number of Participants Reporting Over the Counter Medication Use | Number of participants | Posted | Count of Participants | Participants | 1-14 days or until the participant reports that they are well |
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| Secondary | Change in Transmission to Household Contacts | Number of participants who reported transmission to other members of their household the study period | Posted | Count of Participants | Participants | 1-14 days or until the participant reports that they are well |
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| Secondary | Number of Participants Reporting Side Effects of Nasal Irrigation | Number of participants in intervention arm reporting side effects | NA to Standard Care Group | Posted | Count of Participants | Participants | 1-14 days or until the participant reports that they are well |
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| 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' | Not Posted | 1-14 days or until the participant reports that they are well | Participants |
| Secondary | Cost of Over the Counter Medication Used | Estimated cost requested when participant states over the counter medication used | Not Posted | 1-14 days or until the participant reports that they are well | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Standard Care | Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene. | 0 | 7 | 0 | 7 | 0 | 7 |
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