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

• ClinicalTrials.gov Identifier: NCT03463694
• Recruitment Status: Recruiting
• First Posted: March 13, 2018
• Last Update Posted: September 30, 2022
• Sponsor: University of Edinburgh
• Information provided by (Responsible Party): University of Edinburgh

Tracking Information

• First Submitted Date: February 14, 2018
• First Posted Date: March 13, 2018
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: November 2, 2018
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2019)

Time to the first report that the child is "not unwell". [ Time Frame: Maximum of 28days ]

Time until child not unwell

• Original Primary Outcome Measures (submitted: March 6, 2018): Time to the first report that the child is "not unwell". [ Time Frame: Maximum of 28days ]

Current Secondary Outcome Measures (submitted: April 16, 2019)

• 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
• 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
• 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
• Contacting healthcare (NHS 24, OOH, GP) -Number of participants [ Time Frame: 1-28 days (or until child is well) ]
  Number of participants
• Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts [ Time Frame: 1-28 days (or until child is well) ]
  Number of contacts
• Participants needing GP appointments- Number of participants [ Time Frame: 1-28 days (or until child is well) ]
  Number of appointments
• Participants needing GP appointments- Frequency of contacts [ Time Frame: 1-28 days (or until child is well) ]
  Number of appointments
• Number of participants attending hospital and diagnosis - Number of participants [ Time Frame: 1-28 days (or until child is well) ]
  Number of participants
• Number of participants attending hospital and diagnosis - Frequency of contacts [ Time Frame: 1-28 days (or until child is well) ]
  Number of attendances
• Length of stay in hospital if admitted [ Time Frame: 1-28 days (or until child is well) ]
  Length in Days
• Number of participants reporting wheeze during illness and between end of illness to 28 days [ Time Frame: Day 28 ]
  Number reporting wheeze
• Number of participants reporting over the counter medication use [ Time Frame: 1-28 days (or until child is well) ]
  Number of participants
• Duration of viral shedding [ Time Frame: Days 1-5 ]
  Viral shedding duration in days
• 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.
• Rate of reduction in viral shedding [ Time Frame: Days 1-5 ]
  Rate of viral shedding duration in days
• 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
• Number of participants reporting side effects of nasal drops [ Time Frame: 1-28 days (or until child is well) ]
  Side effects reported
• Types and severity of side effects reported [ Time Frame: 1-28 days (or until child is well) ]
  Side effects reported
• Number of days lost from school/nursery for child [ Time Frame: 1-28 days (or until child is well) ]
  Number of days
• Number of days lost from work for parent/guardian [ Time Frame: 1-28 days (or until child is well) ]
  Number of days
• Cost of over the counter medication used [ Time Frame: 1-28 days (or until child is well) ]
  Cost of medicine used.

Original Secondary Outcome Measures (submitted: March 6, 2018)

• 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
• 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
• 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
• Number of participants contacting healthcare (NHS 24, OOH, GP) [ Time Frame: 1-28 days (or until child is well) ]
• Number of participants needing GP appointments [ Time Frame: 1-28 days (or until child is well) ]
• Number of participants attending hospital and diagnosis [ Time Frame: 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) ]
• Number of participants reporting wheeze within 28 days of onset of illness [ Time Frame: Day 28 ]
• Number of participants reporting over the counter medication use [ Time Frame: 1-28 days (or until child is well) ]
• Duration of viral shedding [ Time Frame: 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.
• Rate of reduction in viral shedding [ Time Frame: 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
• Number of participants reporting side effects of nasal drops [ Time Frame: 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) ]
• Number of days lost from school for child [ Time Frame: 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) ]
• Burden of illness -Cost of intervention [ Time Frame: 1-28 days (or until child is well) ]
• Burden of illness -Cost of over the counter medication used [ Time Frame: 1-28 days (or until child is well) ]
• Burden of illness -Days of school missed [ Time Frame: 1-28 days (or until child is well) ]
• Burden of illness -Days of work missed [ Time Frame: 1-28 days (or until child is well) ]
• Burden of illness - Out of pocket expenses [ Time Frame: 1-28 days (or until child is well) ]
• Burden of illness - Rates of NHS resource used [ Time Frame: 1-28 days (or until child is well) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Masking Description:

The team in the virology lab carrying out the analysis of the nasal swabs will be blinded to the allocation of the participant.

Primary Purpose: Treatment

Condition

• Upper Respiratory Tract Infections
• Virus
• Virus Shedding
• Pediatric ALL

Intervention

Other: Na Cl solution

~2.6% NaCl solution prepared from sea salt

Study Arms

• 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
  Intervention: Other: Na Cl solution
• No Intervention: Standard Care
  Control arm of standard symptomatic care only

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 6, 2018): 480
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2023
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Weeks to 7 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Sandeep Ramalingham; 0131 242 6014; Sandeep.Ramalingam@nhslothian.scot.nhs.uk

Contact: Phillip Rayson; 0131 651 9928; elvis.kids@ed.ac.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03463694
• Other Study ID Numbers: ELVIS Kids
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University of Edinburgh
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Edinburgh
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sandeep Ramalingham; NHS Lothian

• PRS Account: University of Edinburgh
• Verification Date: September 2022