Status:

UNKNOWN

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

Lead Sponsor:

University of Edinburgh

Conditions:

Upper Respiratory Tract Infections

Virus

Eligibility:

All Genders

18+ years

Phase:

NA

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 participan...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

June 23 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2020

Estimated Enrollment :

405 Patients enrolled

Trial Details

Trial ID

NCT04382131

Start Date

June 23 2020

End Date

October 31 2020

Last Update

September 2 2020

Active Locations (1)

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1

NHS Lothian

Edinburgh, United Kingdom