Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids): A Randomised Controlled Trial of Hypertonic Saline Nose Drops in Children With Upper Respiratory Tract Infections (ELVIS Kids)

  • days left to enroll
  • participants needed
  • sponsor
    University of Edinburgh
Updated on 25 October 2022
nasal congestion
sore throat
upper respiratory infection
respiratory symptom
respiratory tract infection
Accepts healthy volunteers


ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of Hypertonic Saline (HS) nose drops (~2.6% NaCl) vs. standard care in children <7 years of age with symptoms of an Upper Respiratory Tract Infection (URTI).


The study will run over ~30 months. Children are recruited prior to, or within 48 hours of developing URTI symptoms by advertising in areas such as local schools, nurseries, health centres and workplaces as well as social media. For the purposes of this study an URTI is defined as: at least two respiratory symptoms (nasal stuffiness, runny nose, cough, sore throat, or sneezing) OR one respiratory symptoms and at least one systemic symptom (lethargy, muscle pain, headache, pyrexia ≥38°C).

Willing parents/guardians, of children <7 years of age, will be directed by the study advertising to contact the research team at their local research site if they are interested in participating. Children will be randomised to either a Control arm of standard symptomatic care, or an Intervention arm of 3 drops each nostril of HS at least 4 times a day until 24 hours after asymptomatic or maximum of 28 days. All participants will be requested to obtain a mid-turbinate nasal swab prior to first nasal HS drops (repeated daily for 5 days), a daily symptom diary (CARIFS, a valid illness measure in the UK), and an end of illness questionnaire (healthcare use, adverse events, acceptability, infection in household contacts, parental time taken off usual activities). Parent/guardian of the children allocated to the intervention arm will be taught how to prepare the HS. Parent/guardian of children who are asymptomatic at recruitment are requested to inform CCRF when the child develops an URTI (within 48 hours) and follow the instructions already provided to them when given the go-ahead to start the trial. On day 28, parents/guardians will be contacted to determine if their child suffered from wheeze either during the illness or at any point until day 28. Participation in the study will end on day 28.

Condition Upper Respiratory Tract Infections, Virus, Virus Shedding, Pediatric ALL
Treatment Na Cl solution
Clinical Study IdentifierNCT03463694
SponsorUniversity of Edinburgh
Last Modified on25 October 2022


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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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