Covid19COVID-HIGHNCT04655638
HFNT vs. COT in COVID-19
A study testing High Flow Nasal Therapy and Conventional Oxygen Therapy in people with Covid19 and Acute Respiratory Failure, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 27 sites in 6 countries.
Trial summary
The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Acute Respiratory Failure
- What is being tested?
- High Flow Nasal Therapy and Conventional Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 10 Feb 2021to 25 Oct 2021
- 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
- Age ≥ 18 years old
- Tested positive for SARS-CoV-2 using real-time reverse transcriptase PCR (RT-PCR) nasopharyngeal swabs
- Clinical signs of acute respiratory infection and radiological evidence of pneumonia
- Hospital admission in any ward or Emergency Department within 48 h
- SpO2 ≤ 92% or PaO2/FiO2 < 300 in room air and need for oxygen therapy according to clinical judgment, at the screening.
Who cannot join
- PaO2/FiO2 ≤ 200
- Respiratory rate ≥ 28 breaths/min and or severe dyspnea and or use of accessory muscles
- Need for immediate intubation or noninvasive ventilation (including CPAP) according to clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory acidosis pH ≤ 7.3)
- Patients already on CPAP/NIV or HFNT at study screening
- Septic shock
- Evidence of multiorgan failure
Show all 12Show fewer
- Glasgow Coma Scale < 13
- Inability to comprehend the study content and give informed consent
- PaCO2 > 45 mmHg, (if blood gas available) or history of chronic hypercapnia
- Patient already on long-term oxygen therapy (LTOT) or home NIV/CPAP (even if only overnight)
- Neuromuscular disease
- Limitation of care based on patients' or physicians' decision
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Italy21 sites
Pulmonology and Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy
Arezzo
Institute of Respiratory Disease, Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari
Bari
U.O. di Medicina interna AULSS 7 Pedemontana
Bassano del Grappa, VI
Ospedale di Carpi
Carpi
Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital, Catania, Italy
Catania
UO di Medicina d'Urgenza AOU Policlinico Vittorio Emanuele San Marco di Catania
Catania
Respiratory Section, Department of Translational Medicine, University of Ferrara. AOU Ferrara Arcispedale S. Anna. U.O. Pneumologia
Ferrara
Department of Medical and Surgical Sciences, University of Foggia. Institute of Respiratory Diseases, University Hospital 'Policlinico Riuniti'
Foggia
UO di Pneumologia ASST Fatebenefratelli Sacco
Milan
AO DEI COLLI - PO Monaldi UO di Pneumologia e Fisiopatologia Respiratoria
Naples
AOU San Luigi Gonzaga
Orbassano
Emergency Department, "S. Maria della Misericordia" Hospital, Perugia, Italy.
Perugia
U.O. di Pneumologia Azienda USL di Pescara
Pescara
UO di Pronto Soccorso e Medicina d'Urgenza AUSL Romagna PO Rimini Ospedale "Inferni"
Rimini
U.O. di PneumoCovid Azienda Ospedaliera San Giovanni di Roma
Roma
UO di Pronto Soccorso e Medicina d'Urgenza Humanitas Research Hospital
Rozzano, Milano
UO di Pneumologia Ospedale S. Bartolomeo
Sarzana
Department of Pneumology, A.O.U. Città della Salute e della Scienza of Turin, Italy.
Turin
U.O. di Pneumologia ASST Settelaghi Ospedale Circolo Fondazione Macchi
Varese
U.O. Medicina Respiratoria del Policlinico G.B. Rossi
Verona
U.O. di Pneumotisiologia Ospedale di Vittorio Veneto Azienda ULSS 2 Marca Trevigiana
Vittorio Veneto
Greece2 sites
Department of Anesthesiology, University of Thessaly, School of Health Sciences, Faculty of Medicine
Larissa
Department of Emergency Medicine, Faculty of Medicine, University of Thessaly
Larissa
Poland1 site
Department of Pneumonology, Faculty of Medical Sciences in Katowice, Medical University of Silesia
Katowice
About this study
Official title: High-Flow Nasal Therapy Versus Conventional Oxygen Therapy in Patients With COVID-19: A Randomized Controlled Trial (The COVID-HIGH Trial)
The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure.
Read the detailed description
The interventions will be delivered in any hospital ward caring for COVID-19 patients.
The interventions under investigation will be high flow nasal therapy in comparison with conventional oxygen therapy.
HFNT will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%. A feeding tube or a nasogastric tube will not represent a contraindication for the use of HFNT provided the patency of the used nostril.
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Co-interventions: Patients potentially eligible for the study will be evaluated by the attending physicians and receive medical therapy based on the attending physician's decision and local protocols. Awake proning is allowed. Local protocols, including drugs and awake proning, will be discussed with the enrolling centers at the initiation visit, and adherence to WHO guidelines will be recommended. Written informed consent from all the patients will be collected.
Termination criteria \& protocol violation: Criteria for weaning off COT or HFNT was at clinical discretion of the managing physician based on the improvement in oxygenation with ability to maintain SpO2 of 96% or greater with less than 0.30 of FiO2 or P/F > 300. The switch from COT to HFNT should be considered a protocol violation and should be based on clinical decision of the treating physician.
Criteria to be considered for escalation of treatment: 1) SpO2 ≤ 92% despite COT or HFNT or P/F ≤ 180 with FiO2 ≥ 50%, and 2) at least one of the following: respiratory rate ≥ 28 breaths/min, severe dyspnea, signs of increased work of breathing (e.g. use of accessory muscles). If the patient meets these criteria, escalation of treatment CPAP, NIV or IMV will be considered.
The choice of the type of escalating treatment will be a clinical decision of the treating physician.
- Conditions
- Covid19, Acute Respiratory Failure
- Being tested
- High Flow Nasal Therapy, Conventional Oxygen Therapy
- Keywords
- COVID-19, HFNT, Respiratory failure, COT, Oxygen, Pneumonia
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal TherapyDevice
High flow nasal therapy will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%.
Conventional Oxygen TherapyDevice
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Therapy | Experimental | High flow nasal therapy Receives: Device: High Flow Nasal Therapy |
| Conventional Oxygen Therapy | Active comparator | Conventional Oxygen therapy Receives: Device: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients needing escalation of treatment during hospital stay
Proportion of patients needing escalation of treatment (i.e. noninvasive ventilation - including CPAP - or intubation).
Measured: 28 days
Secondary outcomes (19)
Proportion of patients needing intubation during hospital stay
Measured: 28 days
Proportion of patients who receive CPAP during hospital stay
Proportion of patients who receive continuous positive airway pressure during hospital stay
Measured: 28 days
Proportion of patients who receive NIV during hospital stay
Proportion of patients undergone noninvasive ventilation (e.g. BiLevel, PSV)
Measured: 28 days
Proportion of patients admitted to intensive care unit during hospital stay
Measured: 28 days
Proportion of patients who terminate the study protocols for improvement
Measured: 28 days
Length of stay in hospital
Measured: 28 days
Time to escalation of treatment to CPAP/NIV during hospital stay
Measured: 28 days
Time to escalation of treatment to intubation/invasive ventilation during hospital stay
Measured: 28 days
Length of stay in ICU
Measured: 28 day
Days free from CPAP/NIV during hospital stay
Measured: 28 days
Ventilator-free days during hospital stay
Measured: 28 days
Oxygen-free days during hospital stay
Measured: 28 days
28-day mortality
Measured: 28 days from hospital admission
60-day mortality
Measured: 60 days from hospital admission
Hospital mortality
Measured: 28 days
Treatment interruption due to intolerance during study treatment
Measured: 28 days
Dyspnea score (BORG scale) during hospital stay
[0= no dyspnea to 10= severe dyspnea] - daily collection
Measured: 28 days
National Early Warning Score 2 (NEWS2) during hospital stay
Daily collection of Six simple physiological parameters that form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. A score is allocated to each parameter, with the magnitude of the score reflecting how extremely the parameter varies from the norm. The score is then aggregated and uplifted by 2 points for people requiring supplemental oxygen to maintain their recommended oxygen saturation. Range of values: 0 (best) - 23 (worst) points.
Measured: 28 days
ROX index during hospital stay
SpO2/FiO2/Respiratory rate - daily collection
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start10 Feb 2021
- Primary completion22 Sep 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded parallel-group randomized multicenter clinical trial
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Responsible party
- Principal investigator, Andrea Cortegiani, MD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Investigators
- Andrea Cortegiani, MD, Principal investigator, University of Palermo. Azienda Ospedaliera Policlinico Paolo GiacconeClaudia Crimi, MD, Principal investigator, Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655638
- Sponsor's protocol ID
- 1th Dec 2020
- Acronym
- COVID-HIGH
- Status last verified
- Oct 2021
- First submitted
- 3 Dec 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
PubMed 33201321Crimi C, Noto A, Cortegiani A, Impellizzeri P, Elliott M, Ambrosino N, Gregoretti C. Noninvasive respiratory support in acute hypoxemic respiratory failure associated with COVID-19 and other viral infections. Minerva Anestesiol. 2020 Nov;86(11):1190-1204. doi: 10.23736/S0375-9393.20.14785-0. Epub 2020 Aug 5.
PubMed 32756535Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.
PubMed 32224769Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
PubMed 29368599Crimi C, Sardo S, Noto A, Madotto F, Ippolito M, Nolasco S, Campisi R, Fiorentino G, Pantazopoulos I, Chalkias A, Mattei A, Scala R, Clini E, Ergan B, Lujan M, Winck JC, Giarratano A, Carlucci A, Gregoretti C, Groff P, Cortegiani A; COVID-HIGH Investigators. High-flow nasal therapy vs conventional oxygen therapy in mild COVID-19 hypoxaemia: a Bayesian reanalysis of the COVID-HIGH Trial. J Anesth Analg Crit Care. 2026 Feb 21;6(1):52. doi: 10.1186/s44158-026-00361-3.
PubMed 41723547Crimi C, Noto A, Madotto F, Ippolito M, Nolasco S, Campisi R, De Vuono S, Fiorentino G, Pantazopoulos I, Chalkias A, Libra A, Mattei A, Scala R, Clini EM, Ergan B, Lujan M, Winck JC, Giarratano A, Carlucci A, Gregoretti C, Groff P, Cortegiani A; COVID-HIGH Investigators. High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial. Thorax. 2023 Apr;78(4):354-361. doi: 10.1136/thoraxjnl-2022-218806. Epub 2022 May 17.
PubMed 35580898
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Therapy Versus Conventional Oxygen Therapy in Patients With COVID-19: A Randomized Controlled Trial (The COVID-HIGH Trial)
- ClinicalTrials.gov ID
- NCT04655638
- Acronym / sponsor ID
- COVID-HIGH / 1th Dec 2020
- Conditions
- Covid19, Acute Respiratory Failure
- Keywords
- COVID-19, HFNT, Respiratory failure, COT, Oxygen, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 7 Dec 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 aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure.
Detailed description
The interventions will be delivered in any hospital ward caring for COVID-19 patients.
The interventions under investigation will be high flow nasal therapy in comparison with conventional oxygen therapy.
HFNT will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%. A feeding tube or a nasogastric tube will not represent a contraindication for the use of HFNT provided the patency of the used nostril.
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Co-interventions: Patients potentially eligible for the study will be evaluated by the attending physicians and receive medical therapy based on the attending physician's decision and local protocols. Awake proning is allowed. Local protocols, including drugs and awake proning, will be discussed with the enrolling centers at the initiation visit, and adherence to WHO guidelines will be recommended. Written informed consent from all the patients will be collected.
Termination criteria \& protocol violation: Criteria for weaning off COT or HFNT was at clinical discretion of the managing physician based on the improvement in oxygenation with ability to maintain SpO2 of 96% or greater with less than 0.30 of FiO2 or P/F > 300. The switch from COT to HFNT should be considered a protocol violation and should be based on clinical decision of the treating physician.
Criteria to be considered for escalation of treatment: 1) SpO2 ≤ 92% despite COT or HFNT or P/F ≤ 180 with FiO2 ≥ 50%, and 2) at least one of the following: respiratory rate ≥ 28 breaths/min, severe dyspnea, signs of increased work of breathing (e.g. use of accessory muscles). If the patient meets these criteria, escalation of treatment CPAP, NIV or IMV will be considered.
The choice of the type of escalating treatment will be a clinical decision of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded parallel-group randomized multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Therapy | Experimental | Device: High Flow Nasal TherapyHigh flow nasal therapy |
| Conventional Oxygen Therapy | Active comparator | Device: Conventional Oxygen TherapyConventional Oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Tested positive for SARS-CoV-2 using real-time reverse transcriptase PCR (RT-PCR) nasopharyngeal swabs
- Clinical signs of acute respiratory infection and radiological evidence of pneumonia
- Hospital admission in any ward or Emergency Department within 48 h
- SpO2 ≤ 92% or PaO2/FiO2 < 300 in room air and need for oxygen therapy according to clinical judgment, at the screening.
Key exclusion criteria (12 listed)
- PaO2/FiO2 ≤ 200
- Respiratory rate ≥ 28 breaths/min and or severe dyspnea and or use of accessory muscles
- Need for immediate intubation or noninvasive ventilation (including CPAP) according to clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory acidosis pH ≤ 7.3)
- Patients already on CPAP/NIV or HFNT at study screening
- Septic shock
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 TherapyHigh flow nasal therapy will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%. | Device | High Flow Nasal Therapy |
| Conventional Oxygen TherapyConventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%. | Device | Conventional Oxygen Therapy |
Primary outcome
Proportion of patients needing escalation of treatment during hospital stay
Time frame: 28 days
Proportion of patients needing escalation of treatment (i.e. noninvasive ventilation - including CPAP - or intubation).
19 secondary outcomes
Proportion of patients needing intubation during hospital stay
Time frame: 28 days
Proportion of patients who receive CPAP during hospital stay
Time frame: 28 days
Proportion of patients who receive NIV during hospital stay
Time frame: 28 days
Proportion of patients admitted to intensive care unit during hospital stay
Time frame: 28 days
Proportion of patients who terminate the study protocols for improvement
Time frame: 28 days
Length of stay in hospital
Time frame: 28 days
Time to escalation of treatment to CPAP/NIV during hospital stay
Time frame: 28 days
Time to escalation of treatment to intubation/invasive ventilation during hospital stay
Time frame: 28 days
Length of stay in ICU
Time frame: 28 day
Days free from CPAP/NIV during hospital stay
Time frame: 28 days
Ventilator-free days during hospital stay
Time frame: 28 days
Oxygen-free days during hospital stay
Time frame: 28 days
28-day mortality
Time frame: 28 days from hospital admission
60-day mortality
Time frame: 60 days from hospital admission
Hospital mortality
Time frame: 28 days
Treatment interruption due to intolerance during study treatment
Time frame: 28 days
Dyspnea score (BORG scale) during hospital stay
Time frame: 28 days
National Early Warning Score 2 (NEWS2) during hospital stay
Time frame: 28 days
ROX index during hospital stay
Time frame: 28 days
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 26 Oct 2021.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 33201321Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
- Background: PubMed 32756535Crimi C, Noto A, Cortegiani A, Impellizzeri P, Elliott M, Ambrosino N, Gregoretti C. Noninvasive respiratory support in acute hypoxemic respiratory failure associated with COVID-19 and other viral infections. Minerva Anestesiol. 2020 Nov;86(11):1190-1204. doi: 10.23736/S0375-9393.20.14785-0. Epub 2020 Aug 5.
- Background: PubMed 32224769Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.
- Background: PubMed 29368599Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
- Derived from this study: PubMed 41723547Crimi C, Sardo S, Noto A, Madotto F, Ippolito M, Nolasco S, Campisi R, Fiorentino G, Pantazopoulos I, Chalkias A, Mattei A, Scala R, Clini E, Ergan B, Lujan M, Winck JC, Giarratano A, Carlucci A, Gregoretti C, Groff P, Cortegiani A; COVID-HIGH Investigators. High-flow nasal therapy vs conventional oxygen therapy in mild COVID-19 hypoxaemia: a Bayesian reanalysis of the COVID-HIGH Trial. J Anesth Analg Crit Care. 2026 Feb 21;6(1):52. doi: 10.1186/s44158-026-00361-3.
- Derived from this study: PubMed 35580898Crimi C, Noto A, Madotto F, Ippolito M, Nolasco S, Campisi R, De Vuono S, Fiorentino G, Pantazopoulos I, Chalkias A, Libra A, Mattei A, Scala R, Clini EM, Ergan B, Lujan M, Winck JC, Giarratano A, Carlucci A, Gregoretti C, Groff P, Cortegiani A; COVID-HIGH Investigators. High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial. Thorax. 2023 Apr;78(4):354-361. doi: 10.1136/thoraxjnl-2022-218806. Epub 2022 May 17.
- Prevention CCfDCa.Link provided by the sponsor.
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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.
Andrea Cortegiani, MD principal investigator
University of Palermo. Azienda Ospedaliera Policlinico Paolo Giaccone
Claudia Crimi, MD principal investigator
Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Therapy and Conventional Oxygen Therapy in people with Covid19 and Acute Respiratory Failure, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 27 sites in 6 countries.
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 5 inclusion and 12 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy, Greece, Poland, Portugal, Spain and 1 more country. 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?
Proportion of patients needing escalation of treatment during hospital stay (time frame: 28 days). 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 NCT04655638, which also lists 8 linked publications.
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 26 Oct 2021.