COVID-19NORMO2NCT06033560
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
An observational study of COVID-19 and Hypoxemic Respiratory Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Hypoxemic Respiratory Failure
- What is being tested?
- High flow nasal oxygen (HFNO, more than 15 L/min)
- Type of treatment
- Medical device
- How many people
- 6,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Sep 2022to Nov 2023
- Phase
- Observational
- 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
Study population: 80 hospital sites across the United States
Who may be able to join
- Sars-Cov-2 infection
- hospital admission (emergency department, inpatient or ICU)
- hypoxemic respiratory failure, defined as P/F ratio below or including 200
Who cannot join
- hypercapnia (PCO2 > 45 mmHG in combination with acidemia (pH < 7.35))
- pregnancy
- do not resuscitate order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure
Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients overwhelmed ICU capacity.
Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation and in selected cases ICU admission. However, data from different studies are conflicting and studies performed in COVID-19 patients are of limited quality. Furthermore, identification of early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of invasive ventilation, which may be associated with adverse clinical outcome. The development and validation of a prediction model, that incorporates readily available clinically data may prove pivotal to fine-tune non-invasive respiratory support.
The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to improve outcome in hospitalized hypoxemic COVID-19 patients.
- Conditions
- COVID-19, Hypoxemic Respiratory Failure
- Being tested
- High flow nasal oxygen (HFNO, more than 15 L/min)
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygen (HFNO, more than 15 L/min)Device
Also called Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure), Conventional oxygen (COT, between 10 - 15 L/min)
Non-invasive respiratory support strategy
| Study group | Role | What they receive |
|---|---|---|
| Full analysis | All eligible patients. Receives: Device: High flow nasal oxygen (HFNO, more than 15 L/min) | |
| P/F ratio subgroups | Patients with a P/F ratio split in groups of <=100; 100-150; 150-200 Receives: Device: High flow nasal oxygen (HFNO, more than 15 L/min) | |
| Respiratory rate subgroups | Patients with a respiratory rate split in groups of <=25; >25 breaths/min Receives: Device: High flow nasal oxygen (HFNO, more than 15 L/min) | |
| Body mass index (BMI) subgroups | Patients with BMI split in groups of <=25; 25-30; 30-35; >35 kg/m^2 Receives: Device: High flow nasal oxygen (HFNO, more than 15 L/min) | |
| Immunocompromised subgroups | Immunocompromised patients due to medication or an underlined condition. Receives: Device: High flow nasal oxygen (HFNO, more than 15 L/min) | |
| Intensive care unit (ICU) subgroup | Only patients eligible within 24 hours of ICU admission. Receives: Device: High flow nasal oxygen (HFNO, more than 15 L/min) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring invasive mechanical ventilation
Measured: 30 days
Secondary outcomes (2)
Mortality at day 30
Measured: 30 days
ICU-free days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start6 Sep 2022
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. L.M.A. Heunks, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033560
- Sponsor's protocol ID
- RP-D0C3E4
- Acronym
- NORMO2
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06033560
- Acronym / sponsor ID
- NORMO2 / RP-D0C3E4
- Conditions
- COVID-19, Hypoxemic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 13 Sep 2023 (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.
Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients overwhelmed ICU capacity.
Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation and in selected cases ICU admission. However, data from different studies are conflicting and studies performed in COVID-19 patients are of limited quality. Furthermore, identification of early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of invasive ventilation, which may be associated with adverse clinical outcome. The development and validation of a prediction model, that incorporates readily available clinically data may prove pivotal to fine-tune non-invasive respiratory support.
The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to improve outcome in hospitalized hypoxemic COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Full analysis | – | Device: High flow nasal oxygen (HFNO, more than 15 L/min)All eligible patients. |
| P/F ratio subgroups | – | Device: High flow nasal oxygen (HFNO, more than 15 L/min)Patients with a P/F ratio split in groups of <=100; 100-150; 150-200 |
| Respiratory rate subgroups | – | Device: High flow nasal oxygen (HFNO, more than 15 L/min)Patients with a respiratory rate split in groups of <=25; >25 breaths/min |
| Body mass index (BMI) subgroups | – | Device: High flow nasal oxygen (HFNO, more than 15 L/min)Patients with BMI split in groups of <=25; 25-30; 30-35; >35 kg/m^2 |
| Immunocompromised subgroups | – | Device: High flow nasal oxygen (HFNO, more than 15 L/min)Immunocompromised patients due to medication or an underlined condition. |
| Intensive care unit (ICU) subgroup | – | Device: High flow nasal oxygen (HFNO, more than 15 L/min)Only patients eligible within 24 hours of ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 hospital sites across the United States
Key inclusion criteria (3 listed)
- Sars-Cov-2 infection
- hospital admission (emergency department, inpatient or ICU)
- hypoxemic respiratory failure, defined as P/F ratio below or including 200
Key exclusion criteria (3 listed)
- hypercapnia (PCO2 > 45 mmHG in combination with acidemia (pH < 7.35))
- pregnancy
- do not resuscitate order
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 |
|---|---|---|
| High flow nasal oxygen (HFNO, more than 15 L/min)Also: Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure), Conventional oxygen (COT, between 10 - 15 L/min)Non-invasive respiratory support strategy | Device | Body mass index (BMI) subgroups, Full analysis, Immunocompromised subgroups, Intensive care unit (ICU) subgroup, P/F ratio subgroups, Respiratory rate subgroups |
Primary outcome
Proportion of patients requiring invasive mechanical ventilation
Time frame: 30 days
2 secondary outcomes
Mortality at day 30
Time frame: 30 days
ICU-free days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No. Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.
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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?
An observational study of COVID-19 and Hypoxemic Respiratory Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 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 Sep 2023. 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 Netherlands. 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?
Results are not available in the source record.
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?
Proportion of patients requiring invasive mechanical ventilation (time frame: 30 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 13 Sep 2023.