Edinburgh and Lothian Virus Intervention Study in Kids

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Upper Respiratory Tract Infections, Virus, Virus Shedding, Pediatric ALL

Intervention / Treatment
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* Other: Na Cl solution


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Children between corrected gestational age of ≥40 weeks and <7 years of age 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 Children needing immediate medical attention Children using saline drops/sprays at the time of randomisation 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) 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) Children being followed up for developmental delay Children receiving the nasal flu vaccine ≤14 days ago Children taking part in another interventional trial If parents/guardians indicating that they are unable to comply with the study protocol prior to randomisation If parents/guardians are unable to understand written or spoken English Children randomised to ELVIS KIDS on a previous episode of URTI Children with a concurrently participating sibling

Ages Eligible for Study
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Minimum Age: 40 Weeks
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of HS nose drops ( 2.6% NaCl) vs. standard care in children <7 years of age with symptoms of an URTI.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic Saline  2.6% NaCl<br>3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days | Other: Na Cl solution<br>*  2.6% NaCl solution prepared from sea salt<br>|
| No Intervention: Standard Care<br>Control arm of standard symptomatic care only | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of all symptoms | 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 | 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 | 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 | Number of participants | 1-28 days (or until child is well) | 
| Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts | Number of contacts | 1-28 days (or until child is well) | 
| Participants needing GP appointments- Number of participants | Number of appointments | 1-28 days (or until child is well) | 
| Participants needing GP appointments- Frequency of contacts | Number of appointments | 1-28 days (or until child is well) | 
| Number of participants attending hospital and diagnosis - Number of participants | Number of participants | 1-28 days (or until child is well) | 
| Number of participants attending hospital and diagnosis - Frequency of contacts | Number of attendances | 1-28 days (or until child is well) | 
| Length of stay in hospital if admitted | 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 | Number reporting wheeze | Day 28 | 
| Number of participants reporting over the counter medication use | Number of participants | 1-28 days (or until child is well) | 
| Duration of viral shedding | Viral shedding duration in days | Days 1-5 | 
| Reduction in viral shedding | 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 | Rate of viral shedding duration in days | Days 1-5 | 
| Reduction in transmission to household contacts | 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 | Side effects reported | 1-28 days (or until child is well) | 
| Types and severity of side effects reported | Side effects reported | 1-28 days (or until child is well) | 
| Number of days lost from school/nursery for child | Number of days | 1-28 days (or until child is well) | 
| Number of days lost from work for parent/guardian | Number of days | 1-28 days (or until child is well) | 
| Cost of over the counter medication used | Cost of medicine used. | 1-28 days (or until child is well) |