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Trial Outcomes & Findings for Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19) (NCT NCT04382131)

NCT ID: NCT04382131

Last Updated: 2026-03-03

Results Overview

Time until participant reports well

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Maximum of 14 days

Results posted on

2026-03-03

Participant Flow

Participant milestones

Participant milestones
Measure
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
Standard Care
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Overall Study
STARTED
9
7
Overall Study
Day 1
8
7
Overall Study
Day 2
8
3
Overall Study
Day 3
7
2
Overall Study
Day 4
3
2
Overall Study
Day 5
4
1
Overall Study
Day 6
3
1
Overall Study
Day 7
3
1
Overall Study
Day 8
3
1
Overall Study
Day 9
2
1
Overall Study
Day 10
2
0
Overall Study
Day 11
2
0
Overall Study
Day 12
2
0
Overall Study
Day 13
2
0
Overall Study
Day 14
1
0
Overall Study
COMPLETED
3
3
Overall Study
NOT COMPLETED
6
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

incomplete information provided by participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=9 Participants
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
Standard Care
n=7 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Total
n=16 Participants
Total of all reporting groups
Age, Continuous
42.63 years
STANDARD_DEVIATION 16.4 • n=9 Participants
37.89 years
STANDARD_DEVIATION 13.28 • n=7 Participants
40.56 years
STANDARD_DEVIATION 14.83 • n=16 Participants
Age, Customized
50 to 70
4 Participants
n=9 Participants
1 Participants
n=7 Participants
5 Participants
n=16 Participants
Age, Customized
<50
5 Participants
n=9 Participants
6 Participants
n=7 Participants
11 Participants
n=16 Participants
Sex: Female, Male
Female
6 Participants
n=9 Participants
1 Participants
n=7 Participants
7 Participants
n=16 Participants
Sex: Female, Male
Male
3 Participants
n=9 Participants
6 Participants
n=7 Participants
9 Participants
n=16 Participants
Race/Ethnicity, Customized
White
8 Participants
n=9 Participants
5 Participants
n=7 Participants
13 Participants
n=16 Participants
Race/Ethnicity, Customized
Mixed/multiple ethnic groups
1 Participants
n=9 Participants
0 Participants
n=7 Participants
1 Participants
n=16 Participants
Race/Ethnicity, Customized
Asian/Asian British
0 Participants
n=9 Participants
2 Participants
n=7 Participants
2 Participants
n=16 Participants
Height
1.72 meters
STANDARD_DEVIATION 0.08 • n=8 Participants • incomplete information provided by participants
1.77 meters
STANDARD_DEVIATION 0.12 • n=4 Participants • incomplete information provided by participants
1.74 meters
STANDARD_DEVIATION 0.10 • n=12 Participants • incomplete information provided by participants
Weight
76.69 kg
STANDARD_DEVIATION 16.54 • n=8 Participants • incomplete information provided by participants
75.74 kg
STANDARD_DEVIATION 26.55 • n=4 Participants • incomplete information provided by participants
76.05 kg
STANDARD_DEVIATION 19.16 • n=12 Participants • incomplete information provided by participants
Smoke
Current
0 Participants
n=8 Participants • incomplete information provided by participants
1 Participants
n=4 Participants • incomplete information provided by participants
1 Participants
n=12 Participants • incomplete information provided by participants
Smoke
Former
4 Participants
n=8 Participants • incomplete information provided by participants
0 Participants
n=4 Participants • incomplete information provided by participants
4 Participants
n=12 Participants • incomplete information provided by participants
Smoke
Never
4 Participants
n=8 Participants • incomplete information provided by participants
3 Participants
n=4 Participants • incomplete information provided by participants
7 Participants
n=12 Participants • incomplete information provided by participants

PRIMARY outcome

Timeframe: Maximum of 14 days

Population: information provided by 8 HSNIG and 3 standard care

Time until participant reports well

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=8 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Time to Resolution of Symptoms as Defined by the Single Question 'How Unwell do You Feel Today'.
5.5 days
Standard Deviation 4.57
4 days
Standard Deviation 3.61

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Population: Information provided by 8 HSNIG and 3 standard care Data collected until participants answer '0' then question not asked again on later days.

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

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=8 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Severity of All Symptoms
Day 5
2.75 units on a scale
Standard Deviation 1.71
1 units on a scale
Severity of All Symptoms
Day 3
2.33 units on a scale
Standard Deviation 1.97
2 units on a scale
Standard Deviation 1.41
Severity of All Symptoms
Day 4
3.33 units on a scale
Standard Deviation 2.08
1.5 units on a scale
Standard Deviation 2.12
Severity of All Symptoms
Day 6
3 units on a scale
Standard Deviation 2
1 units on a scale
Severity of All Symptoms
Day 7
3 units on a scale
Standard Deviation 2
1 units on a scale
Severity of All Symptoms
Day 8
3 units on a scale
Standard Deviation 2.85
1 units on a scale
Severity of All Symptoms
Day 1
3.38 units on a scale
Standard Deviation 0.74
2.33 units on a scale
Standard Deviation 1.15
Severity of All Symptoms
Day 2
2.71 units on a scale
Standard Deviation 1.5
1.33 units on a scale
Standard Deviation 1.53
Severity of All Symptoms
Day 9
2.67 units on a scale
Standard Deviation 2.52
0 units on a scale
Severity of All Symptoms
Day 10
3.5 units on a scale
Standard Deviation 0.71
—
Severity of All Symptoms
Day 11
2.5 units on a scale
Standard Deviation 0.71
—
Severity of All Symptoms
Day 12
2 units on a scale
—
Severity of All Symptoms
Day 13
1 units on a scale
—
Severity of All Symptoms
Day 14
0 units on a scale
Standard Deviation 0
—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Number of participants who contacted healthcare services during the study period

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=3 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Contacting Healthcare (NHS 24, OOH, GP)
Yes
0 Participants
0 Participants
Contacting Healthcare (NHS 24, OOH, GP)
No
3 Participants
3 Participants

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Number of participants and frequency of contacts

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=3 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Participants Needing GP Appointments
No
3 Participants
3 Participants
Participants Needing GP Appointments
Yes
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Number of participants

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=3 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Participants Attending Hospital
Yes
0 Participants
0 Participants
Participants Attending Hospital
No
3 Participants
3 Participants

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Number of days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Number of participants

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=3 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Number of Participants Reporting Over the Counter Medication Use
3 Participants
3 Participants

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Number of participants who reported transmission to other members of their household the study period

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=3 Participants
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
Standard Care
n=3 Participants
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Change in Transmission to Household Contacts
Yes
1 Participants
1 Participants
Change in Transmission to Household Contacts
No
2 Participants
2 Participants

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Population: NA to Standard Care Group

Number of participants in intervention arm reporting side effects

Outcome measures

Outcome measures
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=8 Participants
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
Standard Care
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
Number of Participants Reporting Side Effects of Nasal Irrigation
Yes
7 Participants
—
Number of Participants Reporting Side Effects of Nasal Irrigation
No
1 Participants
—

SECONDARY outcome

Timeframe: 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'

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-14 days or until the participant reports that they are well

Estimated cost requested when participant states over the counter medication used

Outcome measures

Outcome data not reported

Adverse Events

Hypertonic Saline Nasal Irrigation and Gargling

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Standard Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Hypertonic Saline Nasal Irrigation and Gargling
n=9 participants at risk
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
Standard Care
n=7 participants at risk
Participants in the control arm will be given standard NHS guidance for the management of their symptoms and household hygiene.
General disorders
Feeling tired, Shortness of breath, General feeling of discomfort or unease (malaise), Nausea,Chills
11.1%
1/9 • Number of events 5 • study start up to 14 days
0.00%
0/7 • study start up to 14 days

Additional Information

Emily Evans

Edinburgh Clinical Research Facility

Phone: -

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place