Aerosol DiseaseiZephyrNCT04904484
A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients
A study testing iZephyr hood in people with Aerosol Disease and Covid19, run by Imperial College Healthcare NHS Trust.
Trial summary
This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aerosol Disease, Covid19, Noninvasive Ventilation
- What is being tested?
- iZephyr hood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Oct 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II)
- Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III)
Who cannot join
- Patients under the age of 18 years or those lacking capacity
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients
This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.
Read the detailed description
Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT).
Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT.
Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.
- Conditions
- Aerosol Disease, Covid19, Noninvasive Ventilation
- Being tested
- iZephyr hood
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iZephyr hoodDevice
Assessment of an aerosol containment device
| Study group | Role | What they receive |
|---|---|---|
| With i-zephyr | Experimental | using the hood Receives: Device: iZephyr hood |
| Without i-zephyr | No intervention | Not using the hood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy.
Measured: 3 month
Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy inside an iZephyr hood.
Measured: 12 months
Impact of iZephyr hood on environmental SARS Co-V2 contamination
Determine if there is a change in the concentration of SARS-Co-V2 virus on the surfaces and in the air samples surrounding a COVID-19 positive patient whilst using the iZephyr compared to when not using the iZephyr.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerosol DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Environmental contamination of SARS Co-V2 (air and surface) will be tested around COVID patients receiving Non-invasive ventilation or high flow oxygen therapy before using the iZephyr hood and then with the iZephyr hood in place, to determine if the hood changes the amount of environmental contamination
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Mercedes AMG PETRONAS Formula One Team, Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904484
- Sponsor's protocol ID
- 292573
- Acronym
- iZephyr
- Status last verified
- Mar 2024
- First submitted
- 15 Apr 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04904484
- Acronym / sponsor ID
- iZephyr / 292573
- Conditions
- Aerosol Disease, Covid19, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Mercedes AMG PETRONAS Formula One Team, Imperial College London
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 May 2021 (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.
This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.
Detailed description
Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT).
Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT.
Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Environmental contamination of SARS Co-V2 (air and surface) will be tested around COVID patients receiving Non-invasive ventilation or high flow oxygen therapy before using the iZephyr hood and then with the iZephyr hood in place, to determine if the hood changes the amount of environmental contamination
| Arm | Type | Receives |
|---|---|---|
| With i-zephyr | Experimental | Device: iZephyr hoodusing the hood |
| Without i-zephyr | No intervention | –Not using the hood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II)
- Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III)
Key exclusion criteria (1 listed)
- Patients under the age of 18 years or those lacking capacity
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 |
|---|---|---|
| iZephyr hoodAssessment of an aerosol containment device | Device | With i-zephyr |
Primary outcome
Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
Time frame: 3 month
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy.
Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
Time frame: 12 months
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy inside an iZephyr hood.
Impact of iZephyr hood on environmental SARS Co-V2 contamination
Time frame: 12 months
Determine if there is a change in the concentration of SARS-Co-V2 virus on the surfaces and in the air samples surrounding a COVID-19 positive patient whilst using the iZephyr compared to when not using the iZephyr.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing iZephyr hood in people with Aerosol Disease and Covid19, run by Imperial College Healthcare NHS Trust.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priscilla Humado (02033137306, priscilla.humado1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.