Clinical trial NCT03463694: Edinburgh and Lothian Virus Intervention Study in Kids
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Virus
Virus Shedding
Pediatric ALL
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 407
Sex: ALL
Minimum age (years): 40
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to the first report that the child is "not unwell".
timeFrame: Maximum of 28days
Secondary outcomes:
measure: Severity of all symptoms
timeFrame: 1-28 days (or until child is well)
measure: The length of time for individual symptoms to resolve
timeFrame: 1-28 days (or until child is well)
measure: Severity of individual symptoms
timeFrame: 1-28 days (or until child is well)
measure: Contacting healthcare (NHS 24, OOH, GP) -Number of participants
timeFrame: 1-28 days (or until child is well)
measure: Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts
timeFrame: 1-28 days (or until child is well)
measure: Participants needing GP appointments- Number of participants
timeFrame: 1-28 days (or until child is well)
measure: Participants needing GP appointments- Frequency of contacts
timeFrame: 1-28 days (or until child is well)
measure: Number of participants attending hospital and diagnosis - Number of participants
timeFrame: 1-28 days (or until child is well)
measure: Number of participants attending hospital and diagnosis - Frequency of contacts
timeFrame: 1-28 days (or until child is well)
measure: Length of stay in hospital if admitted
timeFrame: 1-28 days (or until child is well)
measure: Number of participants reporting wheeze during illness and between end of illness to 28 days
timeFrame: Day 28
measure: Number of participants reporting over the counter medication use
timeFrame: 1-28 days (or until child is well)
measure: Duration of viral shedding
timeFrame: Days 1-5
measure: Reduction in viral shedding
timeFrame: Days 1-5
measure: Rate of reduction in viral shedding
timeFrame: Days 1-5
measure: Reduction in transmission to household contacts
timeFrame: 1-28 days (or until child is well)
measure: Number of participants reporting side effects of nasal drops
timeFrame: 1-28 days (or until child is well)
measure: Types and severity of side effects reported
timeFrame: 1-28 days (or until child is well)
measure: Number of days lost from school/nursery for child
timeFrame: 1-28 days (or until child is well)
measure: Number of days lost from work for parent/guardian
timeFrame: 1-28 days (or until child is well)
measure: Cost of over the counter medication used
timeFrame: 1-28 days (or until child is well)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Childrens' Clinical Research Facility
Study officials:
affiliation: NHS Lothian
name: Sandeep Ramalingham
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramalingam S, Graham C, Oatey K, Rayson P, Stoddart A, Sheikh A, Cunningham S; ELVIS Kids Trial Investigators. Study protocol of the Edinburgh and Lothian Virus Intervention Study in Kids: a randomised controlled trial of hypertonic saline nose drops in children with upper respiratory tract infections (ELVIS Kids). BMJ Open. 2021 May 5;11(5):e049964. doi: 10.1136/bmjopen-2021-049964.