Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids)

September 27, 2022 updated by: University of Edinburgh

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 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).

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Edinburgh, United Kingdom, EH9 1LF
        • Recruiting
        • Childrens' Clinical Research Facility
        • Contact:
          • Sandeep Ramalingam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  1. Children between corrected gestational age of ≥40 weeks and <7 years of age
  2. Children without URTI OR ≤48 hours of URTI* starting.

    • A URTI being defined as at least two respiratory symptoms (nasal congestion (i.e. stuffy nose), runny nose, cough, sore throat) OR one respiratory symptom + at least one systemic symptom (Low energy/tired, muscle aches/pains, headache, fever ≥38°C).

EXCLUSION CRITERIA

  1. Children needing immediate medical attention
  2. Children using saline drops/sprays at the time of randomisation
  3. Children on immunosuppressive medication, regular oral/inhaled steroids, regular antibiotics (use of antibiotics is allowed as long as the child does not need regular antibiotics)
  4. Children with a known chronic illness (e.g. cystic fibrosis, cardiac, renal, liver, lung, neurological conditions) apart from wheeze or asthma which are not exclusions if the child is otherwise well and not on regular steroids)
  5. Children being followed up for developmental delay
  6. Children receiving the nasal flu vaccine ≤14 days ago
  7. Children taking part in another interventional trial
  8. If parents/guardians indicating that they are unable to comply with the study protocol prior to randomisation
  9. If parents/guardians are unable to understand written or spoken English
  10. Children randomised to ELVIS KIDS on a previous episode of URTI
  11. Children with a concurrently participating sibling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hypertonic Saline ~2.6% NaCl
3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
~2.6% NaCl solution prepared from sea salt
NO_INTERVENTION: Standard Care
Control arm of standard symptomatic care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the first report that the child is "not unwell".
Time Frame: Maximum of 28days
Time until child not unwell
Maximum of 28days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of all symptoms
Time Frame: 1-28 days (or until child is well)
Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
1-28 days (or until child is well)
The length of time for individual symptoms to resolve
Time Frame: 1-28 days (or until child is well)
Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
1-28 days (or until child is well)
Severity of individual symptoms
Time Frame: 1-28 days (or until child is well)
Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
1-28 days (or until child is well)
Contacting healthcare (NHS 24, OOH, GP) -Number of participants
Time Frame: 1-28 days (or until child is well)
Number of participants
1-28 days (or until child is well)
Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts
Time Frame: 1-28 days (or until child is well)
Number of contacts
1-28 days (or until child is well)
Participants needing GP appointments- Number of participants
Time Frame: 1-28 days (or until child is well)
Number of appointments
1-28 days (or until child is well)
Participants needing GP appointments- Frequency of contacts
Time Frame: 1-28 days (or until child is well)
Number of appointments
1-28 days (or until child is well)
Number of participants attending hospital and diagnosis - Number of participants
Time Frame: 1-28 days (or until child is well)
Number of participants
1-28 days (or until child is well)
Number of participants attending hospital and diagnosis - Frequency of contacts
Time Frame: 1-28 days (or until child is well)
Number of attendances
1-28 days (or until child is well)
Length of stay in hospital if admitted
Time Frame: 1-28 days (or until child is well)
Length in Days
1-28 days (or until child is well)
Number of participants reporting wheeze during illness and between end of illness to 28 days
Time Frame: Day 28
Number reporting wheeze
Day 28
Number of participants reporting over the counter medication use
Time Frame: 1-28 days (or until child is well)
Number of participants
1-28 days (or until child is well)
Duration of viral shedding
Time Frame: Days 1-5
Viral shedding duration in days
Days 1-5
Reduction in viral shedding
Time Frame: Days 1-5
Log conversion of each positive result will be done using the following formula: (40-CT of specimen)/3.3 to estimate change in shedding.
Days 1-5
Rate of reduction in viral shedding
Time Frame: Days 1-5
Rate of viral shedding duration in days
Days 1-5
Reduction in transmission to household contacts
Time Frame: 1-28 days (or until child is well)
Questionnaire - reported number of adults and children catching URTI
1-28 days (or until child is well)
Number of participants reporting side effects of nasal drops
Time Frame: 1-28 days (or until child is well)
Side effects reported
1-28 days (or until child is well)
Types and severity of side effects reported
Time Frame: 1-28 days (or until child is well)
Side effects reported
1-28 days (or until child is well)
Number of days lost from school/nursery for child
Time Frame: 1-28 days (or until child is well)
Number of days
1-28 days (or until child is well)
Number of days lost from work for parent/guardian
Time Frame: 1-28 days (or until child is well)
Number of days
1-28 days (or until child is well)
Cost of over the counter medication used
Time Frame: 1-28 days (or until child is well)
Cost of medicine used.
1-28 days (or until child is well)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandeep Ramalingham, NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2018

Primary Completion (ANTICIPATED)

May 31, 2023

Study Completion (ANTICIPATED)

May 31, 2023

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (ACTUAL)

March 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ELVIS Kids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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