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

NCT04382131 | Terminated Results DMC

• 1 other identifier: AC20042
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Severity of All Symptoms

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

• The Length of Time for Individual Symptoms to Resolve

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

• Severity of Individual Symptoms

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

• Contacting Healthcare (NHS 24, OOH, GP)

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

• Participants Needing GP Appointments

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

Study Arms (2)

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.

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.

Interventions

NaCl Solution OTHER

NaCl Solution prepared by participants at home using water and salt

Hypertonic saline nasal irrigation and gargling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Virus Diseases

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Emily Evans
• Organization: Edinburgh Clinical Research Facility

e.evans@ed.ac.uk

-

Study Officials

• Aziz Sheikh

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 11, 2020
• Study Start: June 23, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-03

Locations

GB (1)