Upper Respiratory Tract InfectionsELVIS KidsNCT03463694
Edinburgh and Lothian Virus Intervention Study in Kids
A study testing Na Cl solution in people with Upper Respiratory Tract Infections and Virus, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 weeks to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Virus, Virus Shedding
- What is being tested?
- Na Cl solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 weeks to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Childrens' Clinical Research Facility
Edinburgh, EH9 1LF
About this study
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
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).
Read the 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.
- Being tested
- Na Cl solution
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na Cl solutionOther
~2.6% NaCl solution prepared from sea salt
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saline ~2.6% NaCl | Experimental | 3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days Receives: Other: Na Cl solution |
| Standard Care | No intervention | Control arm of standard symptomatic care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first report that the child is "not unwell".
Time until child not unwell
Measured: Maximum of 28days
Secondary outcomes (21)
Severity of all symptoms
Recorded by parents from options: No Problem, Minor Problem,Moderate Problem,Major Problem or Unknown/Not Applicable
Measured: 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
Measured: 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
Measured: 1-28 days (or until child is well)
Contacting healthcare (NHS 24, OOH, GP) -Number of participants
Number of participants
Measured: 1-28 days (or until child is well)
Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts
Number of contacts
Measured: 1-28 days (or until child is well)
Participants needing GP appointments- Number of participants
Number of appointments
Measured: 1-28 days (or until child is well)
Participants needing GP appointments- Frequency of contacts
Number of appointments
Measured: 1-28 days (or until child is well)
Number of participants attending hospital and diagnosis - Number of participants
Number of participants
Measured: 1-28 days (or until child is well)
Number of participants attending hospital and diagnosis - Frequency of contacts
Number of attendances
Measured: 1-28 days (or until child is well)
Length of stay in hospital if admitted
Length in Days
Measured: 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
Measured: Day 28
Number of participants reporting over the counter medication use
Number of participants
Measured: 1-28 days (or until child is well)
Duration of viral shedding
Viral shedding duration in days
Measured: 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.
Measured: Days 1-5
Rate of reduction in viral shedding
Rate of viral shedding duration in days
Measured: Days 1-5
Reduction in transmission to household contacts
Questionnaire - reported number of adults and children catching URTI
Measured: 1-28 days (or until child is well)
Number of participants reporting side effects of nasal drops
Side effects reported
Measured: 1-28 days (or until child is well)
Types and severity of side effects reported
Side effects reported
Measured: 1-28 days (or until child is well)
Number of days lost from school/nursery for child
Number of days
Measured: 1-28 days (or until child is well)
Number of days lost from work for parent/guardian
Number of days
Measured: 1-28 days (or until child is well)
Cost of over the counter medication used
Cost of medicine used.
Measured: 1-28 days (or until child is well)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start2 Nov 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandeep Ramalingham, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463694
- Sponsor's protocol ID
- ELVIS Kids
- Acronym
- ELVIS Kids
- Status last verified
- May 2024
- First submitted
- 14 Feb 2018
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33952557
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03463694
- Acronym / sponsor ID
- ELVIS Kids / ELVIS Kids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Saline ~2.6% NaCl | Experimental | Other: Na Cl solution3 drops each nostril of Hypertonic Saline (HS) at least 4 times a day until asymptomatic or maximum of 28 days |
| Standard Care | No intervention | –Control arm of standard symptomatic care only |
Who may qualify
- Ages
- 40 weeks to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between corrected gestational age of ≥40 weeks and <7 years of age
- Children without URTI OR ≤48 hours of URTI* starting.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Na Cl solution~2.6% NaCl solution prepared from sea salt | Other | Hypertonic Saline ~2.6% NaCl |
Primary outcome
Time to the first report that the child is "not unwell".
Time frame: Maximum of 28days
Time until child not unwell
21 secondary outcomes
Severity of all symptoms
Time frame: 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)
Severity of individual symptoms
Time frame: 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)
Contacting healthcare (NHS 24, OOH, GP) -Frequency of contacts
Time frame: 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)
Participants needing GP appointments- Frequency of contacts
Time frame: 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 attending hospital and diagnosis - Frequency of contacts
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 during illness and between end of illness to 28 days
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
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)
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/nursery 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)
Cost of over the counter medication used
Time frame: 1-28 days (or until child is well)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 33952557Ramalingam 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Ramalingham principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Na Cl solution in people with Upper Respiratory Tract Infections and Virus, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first report that the child is "not unwell". (time frame: Maximum of 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.