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

NCT ID: NCT04382131

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2020-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NaCl Solution

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NaCl Solution

NaCl Solution prepared by participants at home using water and salt

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aziz Sheikh

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

NHS Lothian

Edinburgh, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Aziz Sheikh

Role: CONTACT

aziz.sheikh@ed.ac.uk

01316514151

Emma Ward

Role: CONTACT

ELVIS-COVID19@ed.ac.uk

01316519910

Facility Contacts

Kenny Scott

Role: primary

Other Identifiers

AC20042

Identifier Type: -

Identifier Source: org_study_id