Severe Acute Respiratory Syndrome Coronavirus 2COVIDNOCHENCT04381923
COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia
A study testing Helmet Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Oxygen (HFNO) in people with Severe Acute Respiratory Syndrome Coronavirus 2 and Hypoxemic Respiratory Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, Hypoxemic Respiratory Failure, Pneumonia, Viral
- What is being tested?
- Helmet Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Oxygen (HFNO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 15 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with confirmed COVID-19 with an Sp02 < 92% on ≥ 6 liters NC admitted to a Penn Medicine advanced respiratory unit. An advanced respiratory unit is a unit capable of non-invasive respiratory support such as an ICU or intermediate care unit.
Who cannot join
- Patients will be excluded if they meet ≥ 1 of the following criteria based on current Penn Medicine respiratory guidelines and prior trials of non-invasive respiratory support:
- Respiratory failure related to other etiology (e.g. exacerbation of chronic obstructive pulmonary disease, acute pulmonary edema)
- Baseline oxygen requirement
- Diagnosis of acute or chronic hypoventilation
- Tracheostomy
- Claustrophobia
Show all 10Show fewer
- Prior intubation during hospitalization
- Urgent need for endotracheal intubation
- Other contraindications to non-invasive respiratory support (glasgow coma scale lower than 8, absence of airway protective gag reflex, elevated intracranial pressure, upper airway obstruction)
- Patient dose not wave to receive the assigned intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia
The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.
Read the detailed description
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can cause acute arterial hypoxemia. Treatment with invasive ventilation improves oxygenation yet results in death in over 50% of cases. The high incidence of disease has also reduced resources needed to safely deliver invasive ventilation including mechanical ventilators and intravenous sedation. Non-invasive respiratory support has been shown to be efficacious in acute hypoxemic respiratory failure from other etiologies and has the potential to reduce rates of intubation and the time spent on mechanical ventilation in COVID-19. However, it is unknown which type of support is the most effective, limiting the ability to improve clinical outcomes and appropriately allocate resources. To help guide clinical practice and policy, it is critical to understand the comparative effectiveness of two forms of non-invasive respiratory support used worldwide, continuous positive airway pressure (CPAP) delivered via a helmet interface and high flow nasal oxygen (HFNO).
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, Hypoxemic Respiratory Failure, Pneumonia, Viral, COVID
- Being tested
- Helmet Continuous Positive Airway Pressure (CPAP), High Flow Nasal Oxygen (HFNO)
- Medical subject headings
- Respiratory Insufficiency, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet Continuous Positive Airway Pressure (CPAP)Device
Helmet CPAP will be initiated at a pressure of 5 cmH20 and fraction of inspired oxygen (Fi02) of < 60%. If oxygen saturation (Sp02) remains < 92%, pressure will be increased to 10 cmH20. FiO2 will then be tapered to target a SpO2 ≥ 92%. Breaks with intervening HFNO use will be provided as needed for meals and during hours of sleep.
High Flow Nasal Oxygen (HFNO)Device
Also called High Flow Nasal Cannula (HFNC)
HFNO will be initiated at a flow rate of 40 LPM and a fraction of inspired oxygen (Fi02) of < 60%. If oxygen saturation (SpO2) remains < 92%, the flow rate will be increased to 60 LPM. FiO2 will then be adjusted to target a SpO2 ≥ 92%. Patients with discomfort due to HFNO may have their flow rate decreased until the discomfort resolves.
| Study group | Role | What they receive |
|---|---|---|
| Helmet Continuous Positive Airway Pressure (CPAP) | Active comparator | When a patient has an Sp02 < 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present. Receives: Device: Helmet Continuous Positive Airway Pressure (CPAP) |
| High Flow Nasal Oxygen (HFNO) | Active comparator | When a patient has an Sp02 < 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present Receives: Device: High Flow Nasal Oxygen (HFNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Free Days (VFD)
VFD is the number of days alive and free of mechanical ventilation in the first 28 days after study enrollment. Death before 28 days will be assigned a VFD equal to 0 to penalize non-survival. In cases of repeated intubation and extubation, periods free from invasive ventilation and lasting at least 24 consecutive hours will be calculated and summed. Timing of intubation and extubation will be captured in hours, and the number of hours a patient received invasive ventilation will be used to calculate duration of ventilation.
Measured: 28 days
Secondary outcomes (4)
ICU and Hospital Length of Stay
Days spent in the ICU and hospital after time of enrollment
Measured: 28 days
Intubation
Incidence and time to intubation in days after the time of enrollment
Measured: 28 days
Renal Replacement Therapy (RRT)
Incidence of RRT after the time of enrollment
Measured: 28 days
Mortality
Death from any cause during after the time of enrollment
Measured: 28 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start15 Nov 2021 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Why it stopped: Unable to obtain IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a randomized study with alternating treatment assignment in which all advanced respiratory units will be assigned to use one of two default interventions (helmet CPAP vs HFNO) as the first-line treatment for refractory hypoxemia (defined as an oxygen saturation (Sp02) of 92% or less on on ≥ 6 LPM (liters per minute) nasal cannula (NC) oxygen). The first-line treatment will be alternated in each unit at 14-day intervals. The initial assignment will be determined by a computer randomization scheme. Patients who are still on their assigned intervention during crossover will remain on that assigned intervention. A design with numerous short periods and frequent crossovers was selected to minimize the risk of changes over time in the patient population and usual care confounding trial results. A 14-day period is also felt to be the minimal time needed to ensure device availability and adherence.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Gaulton, M.D., University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381923
- Sponsor's protocol ID
- 843124
- Acronym
- COVIDNOCHE
- Status last verified
- Mar 2022
- First submitted
- 7 May 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04381923
- Acronym / sponsor ID
- COVIDNOCHE / 843124
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, Hypoxemic Respiratory Failure, Pneumonia, Viral, COVID
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 11 May 2020 (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.
The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.
Detailed description
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can cause acute arterial hypoxemia. Treatment with invasive ventilation improves oxygenation yet results in death in over 50% of cases. The high incidence of disease has also reduced resources needed to safely deliver invasive ventilation including mechanical ventilators and intravenous sedation. Non-invasive respiratory support has been shown to be efficacious in acute hypoxemic respiratory failure from other etiologies and has the potential to reduce rates of intubation and the time spent on mechanical ventilation in COVID-19. However, it is unknown which type of support is the most effective, limiting the ability to improve clinical outcomes and appropriately allocate resources. To help guide clinical practice and policy, it is critical to understand the comparative effectiveness of two forms of non-invasive respiratory support used worldwide, continuous positive airway pressure (CPAP) delivered via a helmet interface and high flow nasal oxygen (HFNO).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized study with alternating treatment assignment in which all advanced respiratory units will be assigned to use one of two default interventions (helmet CPAP vs HFNO) as the first-line treatment for refractory hypoxemia (defined as an oxygen saturation (Sp02) of 92% or less on on ≥ 6 LPM (liters per minute) nasal cannula (NC) oxygen). The first-line treatment will be alternated in each unit at 14-day intervals. The initial assignment will be determined by a computer randomization scheme. Patients who are still on their assigned intervention during crossover will remain on that assigned intervention. A design with numerous short periods and frequent crossovers was selected to minimize the risk of changes over time in the patient population and usual care confounding trial results. A 14-day period is also felt to be the minimal time needed to ensure device availability and adherence.
| Arm | Type | Receives |
|---|---|---|
| Helmet Continuous Positive Airway Pressure (CPAP) | Active comparator | Device: Helmet Continuous Positive Airway Pressure (CPAP)When a patient has an Sp02 < 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present. |
| High Flow Nasal Oxygen (HFNO) | Active comparator | Device: High Flow Nasal Oxygen (HFNO)When a patient has an Sp02 < 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with confirmed COVID-19 with an Sp02 < 92% on ≥ 6 liters NC admitted to a Penn Medicine advanced respiratory unit. An advanced respiratory unit is a unit capable of non-invasive respiratory support such as an ICU or intermediate care unit.
Key exclusion criteria (10 listed)
- Patients will be excluded if they meet ≥ 1 of the following criteria based on current Penn Medicine respiratory guidelines and prior trials of non-invasive respiratory support:
- Respiratory failure related to other etiology (e.g. exacerbation of chronic obstructive pulmonary disease, acute pulmonary edema)
- Baseline oxygen requirement
- Diagnosis of acute or chronic hypoventilation
- Tracheostomy
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 |
|---|---|---|
| Helmet Continuous Positive Airway Pressure (CPAP)Helmet CPAP will be initiated at a pressure of 5 cmH20 and fraction of inspired oxygen (Fi02) of < 60%. If oxygen saturation (Sp02) remains < 92%, pressure will be increased to 10 cmH20. FiO2 will then be tapered to target a SpO2 ≥ 92%. Breaks with intervening HFNO use will be provided as needed for meals and during hours of sleep. | Device | Helmet Continuous Positive Airway Pressure (CPAP) |
| High Flow Nasal Oxygen (HFNO)Also: High Flow Nasal Cannula (HFNC)HFNO will be initiated at a flow rate of 40 LPM and a fraction of inspired oxygen (Fi02) of < 60%. If oxygen saturation (SpO2) remains < 92%, the flow rate will be increased to 60 LPM. FiO2 will then be adjusted to target a SpO2 ≥ 92%. Patients with discomfort due to HFNO may have their flow rate decreased until the discomfort resolves. | Device | High Flow Nasal Oxygen (HFNO) |
Primary outcome
Ventilator-Free Days (VFD)
Time frame: 28 days
VFD is the number of days alive and free of mechanical ventilation in the first 28 days after study enrollment. Death before 28 days will be assigned a VFD equal to 0 to penalize non-survival. In cases of repeated intubation and extubation, periods free from invasive ventilation and lasting at least 24 consecutive hours will be calculated and summed. Timing of intubation and extubation will be captured in hours, and the number of hours a patient received invasive ventilation will be used to calculate duration of ventilation.
4 secondary outcomes
ICU and Hospital Length of Stay
Time frame: 28 days
Intubation
Time frame: 28 days
Renal Replacement Therapy (RRT)
Time frame: 28 days
Mortality
Time frame: 28 days, 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Oxygen (HFNO) in people with Severe Acute Respiratory Syndrome Coronavirus 2 and Hypoxemic Respiratory Failure, run by University of Pennsylvania at 1 site in United States.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 5 Apr 2022. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Ventilator-Free Days (VFD) (time frame: 28 days). 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 5 Apr 2022.