Edinburgh and Lothian Virus Intervention Study in Kids (ELVIS Kids)
Primary Purpose
Upper Respiratory Tract Infections, Virus, Virus Shedding
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Na Cl solution
Sponsored by
About this trial
This is an interventional treatment trial for Upper Respiratory Tract Infections
Eligibility Criteria
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
Sites / Locations
- Childrens' Clinical Research FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hypertonic Saline ~2.6% NaCl
Standard Care
Arm Description
3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
Control arm of standard symptomatic care only
Outcomes
Primary Outcome Measures
Time to the first report that the child is "not unwell".
Time until child not unwell
Secondary Outcome Measures
Severity of all symptoms
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
Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Severity of individual symptoms
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
Number of participants
Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts
Number of contacts
Participants needing GP appointments- Number of participants
Number of appointments
Participants needing GP appointments- Frequency of contacts
Number of appointments
Number of participants attending hospital and diagnosis - Number of participants
Number of participants
Number of participants attending hospital and diagnosis - Frequency of contacts
Number of attendances
Length of stay in hospital if admitted
Length in Days
Number of participants reporting wheeze during illness and between end of illness to 28 days
Number reporting wheeze
Number of participants reporting over the counter medication use
Number of participants
Duration of viral shedding
Viral shedding duration in days
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.
Rate of reduction in viral shedding
Rate of viral shedding duration in days
Reduction in transmission to household contacts
Questionnaire - reported number of adults and children catching URTI
Number of participants reporting side effects of nasal drops
Side effects reported
Types and severity of side effects reported
Side effects reported
Number of days lost from school/nursery for child
Number of days
Number of days lost from work for parent/guardian
Number of days
Cost of over the counter medication used
Cost of medicine used.
Full Information
NCT ID
NCT03463694
First Posted
February 14, 2018
Last Updated
September 27, 2022
Sponsor
University of Edinburgh
1. Study Identification
Unique Protocol Identification Number
NCT03463694
Brief Title
Edinburgh and Lothian Virus Intervention Study in Kids
Acronym
ELVIS 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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Virus, Virus Shedding, Pediatric ALL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertonic Saline ~2.6% NaCl
Arm Type
Experimental
Arm Description
3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Control arm of standard symptomatic care only
Intervention Type
Other
Intervention Name(s)
Na Cl solution
Intervention Description
~2.6% NaCl solution prepared from sea salt
Primary Outcome Measure Information:
Title
Time to the first report that the child is "not unwell".
Description
Time until child not unwell
Time Frame
Maximum of 28days
Secondary Outcome Measure Information:
Title
Severity of all symptoms
Description
Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Time Frame
1-28 days (or until child is well)
Title
The length of time for individual symptoms to resolve
Description
Recorded as: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Time Frame
1-28 days (or until child is well)
Title
Severity of individual symptoms
Description
Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Time Frame
1-28 days (or until child is well)
Title
Contacting healthcare (NHS 24, OOH, GP) -Number of participants
Description
Number of participants
Time Frame
1-28 days (or until child is well)
Title
Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts
Description
Number of contacts
Time Frame
1-28 days (or until child is well)
Title
Participants needing GP appointments- Number of participants
Description
Number of appointments
Time Frame
1-28 days (or until child is well)
Title
Participants needing GP appointments- Frequency of contacts
Description
Number of appointments
Time Frame
1-28 days (or until child is well)
Title
Number of participants attending hospital and diagnosis - Number of participants
Description
Number of participants
Time Frame
1-28 days (or until child is well)
Title
Number of participants attending hospital and diagnosis - Frequency of contacts
Description
Number of attendances
Time Frame
1-28 days (or until child is well)
Title
Length of stay in hospital if admitted
Description
Length in Days
Time Frame
1-28 days (or until child is well)
Title
Number of participants reporting wheeze during illness and between end of illness to 28 days
Description
Number reporting wheeze
Time Frame
Day 28
Title
Number of participants reporting over the counter medication use
Description
Number of participants
Time Frame
1-28 days (or until child is well)
Title
Duration of viral shedding
Description
Viral shedding duration in days
Time Frame
Days 1-5
Title
Reduction in viral shedding
Description
Log conversion of each positive result will be done using the following formula: (40-CT of specimen)/3.3 to estimate change in shedding.
Time Frame
Days 1-5
Title
Rate of reduction in viral shedding
Description
Rate of viral shedding duration in days
Time Frame
Days 1-5
Title
Reduction in transmission to household contacts
Description
Questionnaire - reported number of adults and children catching URTI
Time Frame
1-28 days (or until child is well)
Title
Number of participants reporting side effects of nasal drops
Description
Side effects reported
Time Frame
1-28 days (or until child is well)
Title
Types and severity of side effects reported
Description
Side effects reported
Time Frame
1-28 days (or until child is well)
Title
Number of days lost from school/nursery for child
Description
Number of days
Time Frame
1-28 days (or until child is well)
Title
Number of days lost from work for parent/guardian
Description
Number of days
Time Frame
1-28 days (or until child is well)
Title
Cost of over the counter medication used
Description
Cost of medicine used.
Time Frame
1-28 days (or until child is well)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Weeks
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep Ramalingham
Phone
0131 242 6014
Email
Sandeep.Ramalingam@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip Rayson
Phone
0131 651 9928
Email
elvis.kids@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Ramalingham
Organizational Affiliation
NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens' Clinical Research Facility
City
Edinburgh
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Ramalingam
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33952557
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.
Results Reference
derived
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Edinburgh and Lothian Virus Intervention Study in Kids
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