COVID-19AW-PP_CovidNCT05178212
Characteristics and Outcomes of Patients With COVID-19 Treated With HFNO and Prone Positioning
An observational study of COVID-19 and Respiratory Failure, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
A subset of patients with COVID-19 develops acute respiratory failure and acute respiratory distress syndrome (ARDS) (1). The use of invasive mechanical ventilation for the treatment of these conditions is associated with high mortality rates (2,3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Respiratory Failure, Prone Position
- How many people
- 600 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Apr 2020to 31 Dec 2022
- How long will I take part?
- 4 Weeks
- 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: We included patients older than 17 years admitted to the ICU with a confirmed diagnosis of COVID-19 (real-time PCR) and receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: a) peripheral oxygen saturation (SpO2) < 92% with oxygen > 4 liters/minute; b) increased work of breathing with use of accessory respiratory muscles, and a respiratory rate > 30/min; c) PaO2/FiO2ratio < 200 mmHg. Patients with respiratory failure secondary to a different etiology, decreased level of consciousness, presence of shock requiring vasopressors, immediate need for intubation, use of positive-pressure ventilation prior to HFNO, and with do-not intubate orders were excluded.
Who may be able to join
- Older than 17 years, admitted to the ICU
- Confirmed diagnosis of COVID-19 (real-time PCR)
- Receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: peripheral oxygen saturation (SpO2) < 92% with oxygen > 4 liters/minute; increased work of breathing with use of accessory respiratory muscles, and a respiratory rate > 30/min; PaO2/FiO2ratio < 200 mmHg.
Who cannot join
- Patients with respiratory failure secondary to a different etiology,
- Decreased level of consciousness,
- Presence of shock requiring vasopressors,
- Immediate need for intubation.
- Use of positive-pressure ventilation prior to HFNO, and f) with do-not intubate orders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Outcomes of Patients With COVID-19-related Acute Respiratory Failure Treated With High-flow Nasal Oxygen and Awake-prone Position
A subset of patients with COVID-19 develops acute respiratory failure and acute respiratory distress syndrome (ARDS) (1). The use of invasive mechanical ventilation for the treatment of these conditions is associated with high mortality rates (2,3). The use of high-flow nasal oxygen therapy (HFNO) and awake prone position (AW-PP) could to decrease the need for endotracheal intubation and other adverse clinical outcomes (4-6).
The aim of this study is to evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.
Read the detailed description
Objective. To evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.
Design: Prospective multicenter cohort study conducted at 5 ICUs of 5 centers in Argentina. The Internal Review Board from the 5 centers approved the study including waived informed consent. The interventions carried out were part of the usual practice at each center and confidentiality of participants was guaranteed.
Population. Patients older than 18 years admitted to the ICU with a confirmed diagnosis of COVID-19 (real-time PCR) and receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: a) peripheral oxygen saturation (SpO2) < 92% with oxygen > 4 liters/minute; b) increased work of breathing with use of accessory respiratory muscles, and a respiratory rate > 30/min; c) partial pressure of oxygen /Fraction of inspired oxygen (PaO2/FiO2ratio) < 200 mmHg. Patients with respiratory failure secondary to a different etiology, decreased level of consciousness, presence of shock requiring vasopressors, immediate need for intubation, use of positive-pressure ventilation prior to HFNO, and with do-not intubate orders were excluded.
Procedures.Immediately after admission to the ICU, the inclusion criteria regarding oxygenation and/or work of breathing are checked. Then a high-flow nasal cannula sized according to the nares size is placed, and connected to a specific device for the provision of high-flow O2. The initial flow is 50-70 L/min, with the fraction of inspired oxygen (FiO2) necessary to obtain an SpO2 > 92%. No maximum FiO2 limits is established. Once therapy with HFNO is started, participants are encouraged and assisted by the health-care team to rotate from supine to prone position for as long as possible, taking breaks for personal hygiene and eating. No maximum time limits for prone position are established. Patients who tolerated HFNO for the next 4 hours are included in the study. These interventions are maintained during the study period until one of the following criteria was met: maintenance of SpO2 > 92% with FiO2 ≤ 40%, and flow ≤ 40 L/min for a period > 12 hours in the supine position; or endotracheal intubation. Analgesic drugs (opioids, paracetamol) or light sedation (dexmedetomidine) was allowed and indicated according to the criteria of the health-care team.
Variables and measurements. The following variables are collected: demographics (age, sex, body mass index [BMI]), comorbidities, severity scores upon ICU admission (APACHE II and SOFA), chronology of the disease (time from the onset of symptoms to hospital admission and ICU admission), vital signs, laboratory parameters, Respiratory rate Oxygenation index (ROX index) [7] , and chest computed tomography score (CT score) determined as the sum of lung involvement, ranging from 0 -no involvement- to 25 -maximum involvement [8].
Exposure: The main exposure of this study was awake prone positioning. The investigators will evaluate the number and proportion of patients who tolerate and cannot tolerate the prone position. For those who tolerate the prone position, the investigators record information on the number of hours in prone, and the number of days in prone position per patient. Additionally the following data is recorded: a) the predominant position adopted by the patient, defined as the position in which the patient spent most h/day, i.e., prone, lateral or supine position; b) the average number of h/day in that position; and c) the number of days of exposure to said position for a period of ≥ 6 h/day (AW-PP).
The primary outcome is defined as the receipt of endotracheal intubation. The decision to intubate was based on the criteria of the attending health-care team. However, intubation is recommended for anyone meeting the following criteria: deterioration of neurologic status, hemodynamic instability, or if two or more of the following criteria were met: decline in oxygen saturation with SpO2 < 90% for more than 5 minutes (not explained by technical failures), lack of improvement in the signs of respiratory muscle fatigue, impossibility to control airway secretions and respiratory acidosis with log10 hydrogen ion concentration (pH) < 7.30 [9]. Secondary outcome: hospital mortality. Secondary clinical outcomes: ICU and hospital length of stay, time to endotracheal intubation, and severe complications related to AW-PP.
Statistical analysis. The dynamics of the pandemic and the number of patients admitted to ICUs cannot be predicted. As many patients as possible were consecutively recruited without a predefined sample size (estimated 600).
Descriptive statistics will be used to describe the baseline characteristics of the patients. Categorical data will be presented as absolute frequency (n) and percentage (%) and continuous data as mean ± standard deviation (SD) or median and interquartile range (IR), respectively, as appropriate. Categorical variables will be compared by chi-square test (with Yates correction) or Fisher's exact tests, as appropriate. Continuous quantitative variables will be compared using the unpaired t-test or the Mann-Whitney test for normally and non-normally distributed variables, respectively. Each test will be two-tailed and a value of p<0.05 will be considered statistically significant. All analyses will be performed with STATA version 15.1.
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal Intubation
Requirement of endotracheal intubation according to the criteria of previous studies (9,10).
Measured: Up to 4 weeks
Secondary outcomes (1)
In-hospital mortality.
In-hospital mortality
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start15 Apr 2020
- Primary completion30 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Aleman, Austral University, Argentina
- Responsible party
- Principal investigator, Mariano Esperatti, Hospital Privado de Comunidad de Mar del Plata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178212
- Sponsor's protocol ID
- AW-PP_Covid-19
- Acronym
- AW-PP_Covid
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2021
- Last updated
- 27 Jan 2026
- 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 32091533Karagiannidis C, Mostert C, Hentschker C, Voshaar T, Malzahn J, Schillinger G, Klauber J, Janssens U, Marx G, Weber-Carstens S, Kluge S, Pfeifer M, Grabenhenrich L, Welte T, Busse R. Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study. Lancet Respir Med. 2020 Sep;8(9):853-862. doi: 10.1016/S2213-2600(20)30316-7. Epub 2020 Jul 28.
PubMed 32735842Ranzani OT, Bastos LSL, Gelli JGM, Marchesi JF, Baiao F, Hamacher S, Bozza FA. Characterisation of the first 250,000 hospital admissions for COVID-19 in Brazil: a retrospective analysis of nationwide data. Lancet Respir Med. 2021 Apr;9(4):407-418. doi: 10.1016/S2213-2600(20)30560-9. Epub 2021 Jan 15.
PubMed 33460571Tan W, Xu DY, Xu MJ, Wang ZF, Dai B, Li LL, Zhao HW, Wang W, Kang J. The efficacy and tolerance of prone positioning in non-intubation patients with acute hypoxemic respiratory failure and ARDS: a meta-analysis. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211009407. doi: 10.1177/17534666211009407.
PubMed 33888007Ponnapa Reddy M, Subramaniam A, Afroz A, Billah B, Lim ZJ, Zubarev A, Blecher G, Tiruvoipati R, Ramanathan K, Wong SN, Brodie D, Fan E, Shekar K. Prone Positioning of Nonintubated Patients With Coronavirus Disease 2019-A Systematic Review and Meta-Analysis. Crit Care Med. 2021 Oct 1;49(10):e1001-e1014. doi: 10.1097/CCM.0000000000005086.
PubMed 33927120Cardona S, Downing J, Alfalasi R, Bzhilyanskaya V, Milzman D, Rehan M, Schwartz B, Yardi I, Yazdanpanah F, Tran QK. Intubation rate of patients with hypoxia due to COVID-19 treated with awake proning: A meta-analysis. Am J Emerg Med. 2021 May;43:88-96. doi: 10.1016/j.ajem.2021.01.058. Epub 2021 Jan 27.
PubMed 33550104Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
PubMed 30576221Francone M, Iafrate F, Masci GM, Coco S, Cilia F, Manganaro L, Panebianco V, Andreoli C, Colaiacomo MC, Zingaropoli MA, Ciardi MR, Mastroianni CM, Pugliese F, Alessandri F, Turriziani O, Ricci P, Catalano C. Chest CT score in COVID-19 patients: correlation with disease severity and short-term prognosis. Eur Radiol. 2020 Dec;30(12):6808-6817. doi: 10.1007/s00330-020-07033-y. Epub 2020 Jul 4.
PubMed 32623505Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682.
PubMed 33764378Olmos M, Fuentes N, Busico M, Gallardo A, Vitali A, Costa ELV, Amato MBP, Bruhn A, Esperatti M; Argentine Collaborative Group on High Flow, Prone Positioning. Effectiveness of bundle of care on tolerance of awake-prone positioning in patients with acute respiratory failure. A multicenter observational study. Intensive Care Med. 2025 Feb;51(2):332-341. doi: 10.1007/s00134-025-07804-5. Epub 2025 Feb 17.
PubMed 39961842Busico M, Fuentes NA, Gallardo A, Vitali A, Quintana J, Olmos M, Burns KEA, Esperatti M; Argentine Collaborative Group on High Flow and Prone Positioning. The Predictive Validity of the Berlin Definition of Acute Respiratory Distress Syndrome for Patients With COVID-19-Related Respiratory Failure Treated With High-Flow Nasal Oxygen: A Multicenter, Prospective Cohort Study. Crit Care Med. 2024 Jan 1;52(1):92-101. doi: 10.1097/CCM.0000000000006056. Epub 2023 Oct 16.
PubMed 37846935
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Patients With COVID-19-related Acute Respiratory Failure Treated With High-flow Nasal Oxygen and Awake-prone Position
- ClinicalTrials.gov ID
- NCT05178212
- Acronym / sponsor ID
- AW-PP_Covid / AW-PP_Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Collaborators
- Hospital Aleman, Austral University, Argentina
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jan 2022 (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.
A subset of patients with COVID-19 develops acute respiratory failure and acute respiratory distress syndrome (ARDS) (1). The use of invasive mechanical ventilation for the treatment of these conditions is associated with high mortality rates (2,3). The use of high-flow nasal oxygen therapy (HFNO) and awake prone position (AW-PP) could to decrease the need for endotracheal intubation and other adverse clinical outcomes (4-6).
The aim of this study is to evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.
Detailed description
Objective. To evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.
Design: Prospective multicenter cohort study conducted at 5 ICUs of 5 centers in Argentina. The Internal Review Board from the 5 centers approved the study including waived informed consent. The interventions carried out were part of the usual practice at each center and confidentiality of participants was guaranteed.
Population. Patients older than 18 years admitted to the ICU with a confirmed diagnosis of COVID-19 (real-time PCR) and receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: a) peripheral oxygen saturation (SpO2) < 92% with oxygen > 4 liters/minute; b) increased work of breathing with use of accessory respiratory muscles, and a respiratory rate > 30/min; c) partial pressure of oxygen /Fraction of inspired oxygen (PaO2/FiO2ratio) < 200 mmHg. Patients with respiratory failure secondary to a different etiology, decreased level of consciousness, presence of shock requiring vasopressors, immediate need for intubation, use of positive-pressure ventilation prior to HFNO, and with do-not intubate orders were excluded.
Procedures.Immediately after admission to the ICU, the inclusion criteria regarding oxygenation and/or work of breathing are checked. Then a high-flow nasal cannula sized according to the nares size is placed, and connected to a specific device for the provision of high-flow O2. The initial flow is 50-70 L/min, with the fraction of inspired oxygen (FiO2) necessary to obtain an SpO2 > 92%. No maximum FiO2 limits is established. Once therapy with HFNO is started, participants are encouraged and assisted by the health-care team to rotate from supine to prone position for as long as possible, taking breaks for personal hygiene and eating. No maximum time limits for prone position are established. Patients who tolerated HFNO for the next 4 hours are included in the study. These interventions are maintained during the study period until one of the following criteria was met: maintenance of SpO2 > 92% with FiO2 ≤ 40%, and flow ≤ 40 L/min for a period > 12 hours in the supine position; or endotracheal intubation. Analgesic drugs (opioids, paracetamol) or light sedation (dexmedetomidine) was allowed and indicated according to the criteria of the health-care team.
Variables and measurements. The following variables are collected: demographics (age, sex, body mass index [BMI]), comorbidities, severity scores upon ICU admission (APACHE II and SOFA), chronology of the disease (time from the onset of symptoms to hospital admission and ICU admission), vital signs, laboratory parameters, Respiratory rate Oxygenation index (ROX index) [7] , and chest computed tomography score (CT score) determined as the sum of lung involvement, ranging from 0 -no involvement- to 25 -maximum involvement [8].
Exposure: The main exposure of this study was awake prone positioning. The investigators will evaluate the number and proportion of patients who tolerate and cannot tolerate the prone position. For those who tolerate the prone position, the investigators record information on the number of hours in prone, and the number of days in prone position per patient. Additionally the following data is recorded: a) the predominant position adopted by the patient, defined as the position in which the patient spent most h/day, i.e., prone, lateral or supine position; b) the average number of h/day in that position; and c) the number of days of exposure to said position for a period of ≥ 6 h/day (AW-PP).
The primary outcome is defined as the receipt of endotracheal intubation. The decision to intubate was based on the criteria of the attending health-care team. However, intubation is recommended for anyone meeting the following criteria: deterioration of neurologic status, hemodynamic instability, or if two or more of the following criteria were met: decline in oxygen saturation with SpO2 < 90% for more than 5 minutes (not explained by technical failures), lack of improvement in the signs of respiratory muscle fatigue, impossibility to control airway secretions and respiratory acidosis with log10 hydrogen ion concentration (pH) < 7.30 [9]. Secondary outcome: hospital mortality. Secondary clinical outcomes: ICU and hospital length of stay, time to endotracheal intubation, and severe complications related to AW-PP.
Statistical analysis. The dynamics of the pandemic and the number of patients admitted to ICUs cannot be predicted. As many patients as possible were consecutively recruited without a predefined sample size (estimated 600).
Descriptive statistics will be used to describe the baseline characteristics of the patients. Categorical data will be presented as absolute frequency (n) and percentage (%) and continuous data as mean ± standard deviation (SD) or median and interquartile range (IR), respectively, as appropriate. Categorical variables will be compared by chi-square test (with Yates correction) or Fisher's exact tests, as appropriate. Continuous quantitative variables will be compared using the unpaired t-test or the Mann-Whitney test for normally and non-normally distributed variables, respectively. Each test will be two-tailed and a value of p<0.05 will be considered statistically significant. All analyses will be performed with STATA version 15.1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included patients older than 17 years admitted to the ICU with a confirmed diagnosis of COVID-19 (real-time PCR) and receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: a) peripheral oxygen saturation (SpO2) < 92% with oxygen > 4 liters/minute; b) increased work of breathing with use of accessory respiratory muscles, and a respiratory rate > 30/min; c) PaO2/FiO2ratio < 200 mmHg. Patients with respiratory failure secondary to a different etiology, decreased level of consciousness, presence of shock requiring vasopressors, immediate need for intubation, use of positive-pressure ventilation prior to HFNO, and with do-not intubate orders were excluded.
Key inclusion criteria (3 listed)
- Older than 17 years, admitted to the ICU
- Confirmed diagnosis of COVID-19 (real-time PCR)
- Receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: peripheral oxygen saturation (SpO2) < 92% with oxygen > 4 liters/minute; increased work of breathing with use of accessory respiratory muscles, and a respiratory rate > 30/min; PaO2/FiO2ratio < 200 mmHg.
Key exclusion criteria (5 listed)
- Patients with respiratory failure secondary to a different etiology,
- Decreased level of consciousness,
- Presence of shock requiring vasopressors,
- Immediate need for intubation.
- Use of positive-pressure ventilation prior to HFNO, and f) with do-not intubate orders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endotracheal Intubation
Time frame: Up to 4 weeks
Requirement of endotracheal intubation according to the criteria of previous studies (9,10).
1 secondary outcome
In-hospital mortality.
Time frame: Up to 24 weeks
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 27 Jan 2026.
- Results publication: 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.
- Results publication: PubMed 32735842Karagiannidis C, Mostert C, Hentschker C, Voshaar T, Malzahn J, Schillinger G, Klauber J, Janssens U, Marx G, Weber-Carstens S, Kluge S, Pfeifer M, Grabenhenrich L, Welte T, Busse R. Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study. Lancet Respir Med. 2020 Sep;8(9):853-862. doi: 10.1016/S2213-2600(20)30316-7. Epub 2020 Jul 28.
- Results publication: PubMed 33460571Ranzani OT, Bastos LSL, Gelli JGM, Marchesi JF, Baiao F, Hamacher S, Bozza FA. Characterisation of the first 250,000 hospital admissions for COVID-19 in Brazil: a retrospective analysis of nationwide data. Lancet Respir Med. 2021 Apr;9(4):407-418. doi: 10.1016/S2213-2600(20)30560-9. Epub 2021 Jan 15.
- Results publication: PubMed 33888007Tan W, Xu DY, Xu MJ, Wang ZF, Dai B, Li LL, Zhao HW, Wang W, Kang J. The efficacy and tolerance of prone positioning in non-intubation patients with acute hypoxemic respiratory failure and ARDS: a meta-analysis. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211009407. doi: 10.1177/17534666211009407.
- Results publication: PubMed 33927120Ponnapa Reddy M, Subramaniam A, Afroz A, Billah B, Lim ZJ, Zubarev A, Blecher G, Tiruvoipati R, Ramanathan K, Wong SN, Brodie D, Fan E, Shekar K. Prone Positioning of Nonintubated Patients With Coronavirus Disease 2019-A Systematic Review and Meta-Analysis. Crit Care Med. 2021 Oct 1;49(10):e1001-e1014. doi: 10.1097/CCM.0000000000005086.
- Results publication: PubMed 33550104Cardona S, Downing J, Alfalasi R, Bzhilyanskaya V, Milzman D, Rehan M, Schwartz B, Yardi I, Yazdanpanah F, Tran QK. Intubation rate of patients with hypoxia due to COVID-19 treated with awake proning: A meta-analysis. Am J Emerg Med. 2021 May;43:88-96. doi: 10.1016/j.ajem.2021.01.058. Epub 2021 Jan 27.
- Results publication: PubMed 30576221Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
- Results publication: PubMed 32623505Francone M, Iafrate F, Masci GM, Coco S, Cilia F, Manganaro L, Panebianco V, Andreoli C, Colaiacomo MC, Zingaropoli MA, Ciardi MR, Mastroianni CM, Pugliese F, Alessandri F, Turriziani O, Ricci P, Catalano C. Chest CT score in COVID-19 patients: correlation with disease severity and short-term prognosis. Eur Radiol. 2020 Dec;30(12):6808-6817. doi: 10.1007/s00330-020-07033-y. Epub 2020 Jul 4.
- Results publication: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- Results publication: PubMed 33764378Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682.
- Derived from this study: PubMed 39961842Olmos M, Fuentes N, Busico M, Gallardo A, Vitali A, Costa ELV, Amato MBP, Bruhn A, Esperatti M; Argentine Collaborative Group on High Flow, Prone Positioning. Effectiveness of bundle of care on tolerance of awake-prone positioning in patients with acute respiratory failure. A multicenter observational study. Intensive Care Med. 2025 Feb;51(2):332-341. doi: 10.1007/s00134-025-07804-5. Epub 2025 Feb 17.
- Derived from this study: PubMed 37846935Busico M, Fuentes NA, Gallardo A, Vitali A, Quintana J, Olmos M, Burns KEA, Esperatti M; Argentine Collaborative Group on High Flow and Prone Positioning. The Predictive Validity of the Berlin Definition of Acute Respiratory Distress Syndrome for Patients With COVID-19-Related Respiratory Failure Treated With High-Flow Nasal Oxygen: A Multicenter, Prospective Cohort Study. Crit Care Med. 2024 Jan 1;52(1):92-101. doi: 10.1097/CCM.0000000000006056. Epub 2023 Oct 16.
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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 Respiratory Failure, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
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 5 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 27 Jan 2026. 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 Argentina. 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?
Endotracheal Intubation (time frame: Up to 4 weeks). 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 NCT05178212, which also lists 12 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 27 Jan 2026.