Respiratory InsufficiencyRENOVATENCT03643939
High-Flow Nasal Oxygen Cannula Compared to Non-Invasive Ventilation in Adult Patients With AcuTE Respiratory Failure
A study testing High Flow Nasal Catheter and Noninvasive ventilation in people with Respiratory Insufficiency and Respiratory Failure, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
RENOVATE study aims to investigate if the respiratory support device called High-Flow Nasal Oxygen Cannula (HFNC) acts similarly (non-inferior) to another respiratory support device called Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation in adult patients with Acute Respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Failure
- What is being tested?
- High Flow Nasal Catheter and Noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,801 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2019to 28 Feb 2024
- 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
None listed.
Who cannot join
- Indication of emergency ETI:
- Prolonged respiratory pauses
- Cardiorespiratory arrest
- Glasgow ≤12
- HR < 50 bpm with decreased level of consciousness
- pH < 7.15 irrespective of the cause
Show all 24Show fewer
- Psychomotor agitation that prevents adequate medical / nursing care requiring heavy sedation
- Persistent hemodynamic instability with MAP <65 mmHg, SBP <90 mmHg after adequate volume resuscitation or requiring norepinephrine> 0.3 microg / kg / min or equivalent.
- Contraindications to non-invasive ventilation: face deformities or traumas, recent esophageal surgery, hypersecretion, vomiting with aspiration risk
- Presence of pneumothorax or extensive pleural effusion
- Severe arrhythmias at risk of hemodynamic instability
- Thoracic trauma understood as the main cause of ARF
- Asthma attack
- Pregnancy
- Cardiogenic Shock
- Acute Coronary Syndromes with plans to undergo coronary angiography within 24 hs
- ARF after orotracheal extubation (up to 72 hours after extubation)
- Post-surgical ARF (surgery within 72 hours)
- Hypercapnic ARF due to neuromuscular disease or chest deformities
- Patients on exclusive palliative care
- Do Not Intubate order (DNI)
- Chronic pulmonary disease except COPD
- Use of more than 6 hours of NIPPV before randomization if hypoxemic ARF in the non-immunosuppressed, in the immunosuppressed hypoxemic, or if exacerbated COPD
- Use of NIPPV before randomization in the cardiogenic acute pulmonary edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RandomizEd Adaptive Trial of High-Flow Nasal Oxygen Cannula Compared to Non-Invasive Ventilation for AcuTE Respiratory Failure
RENOVATE study aims to investigate if the respiratory support device called High-Flow Nasal Oxygen Cannula (HFNC) acts similarly (non-inferior) to another respiratory support device called Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation in adult patients with Acute Respiratory Failure (ARF) from different causes. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is that, even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same beneficial effect of NIPPV while being easier tolerated, allowing patients to talk, eat and drink through mouth while on HFNC. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications.
[IMPORTANT NOTE] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.
Read the detailed description
RENOVATE will investigate if High-Flow Nasal Oxygen Cannula (HFNC) is non-inferior to Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation or death in adult patients with Acute Respiratory Failure (ARF) from different causes in 7 days. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. Even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC may have beneficial effect over NIPPV because it is easier to be tolerated, allowing patients to talk, eat and drink through mouth while on therapy. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. The main hypothesis is that HFNC is non inferior to NIPPV in reducing intubation rate or death within 7 days. However, as an adaptive study, this non inferiority hypothesis may change to superiority if gathered data during the study is promissing in the interim analysis. Therefore, sample size may increase to 2000 participants. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications.
[IMPORTANT NOTE] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.
Trial Update:
We have collected Covid 19 information since march 2020 as an added question in the CRF. There are two questions: one in the elegibility criteria form asking if Covid 19 is suspected and another one in the discharge form asking if Covid 19 was laboratory confirmed. Since then, there were considerably change in prevalence of acute respiratory failure subgroups since the beginning of the trial in 2019. Covid 19, nowdays, is responsible for 63% of our sample size, followed by hypoxemic non immunocompromised subgroup with 19%, acute pulmonary edema and hypoxemic immunocompromised with 8% and finally COPD with 2%. These prevalences are completely different from our previous assumptions in 2019 trial simulations as published in our protocol and statistical analysis plan in March 2022 Volume 24 Number 1 at Critical Care Resuscitation journal. Therefore, the Steering Committee decided that all Covid 19 patients, independent of previous subgroup allocation, would be analysed separately in a 5th subgroup. Update in simulations with different scenarios and new statistical models were done by March 13th 2023 to account for the 5th interim analysis which you can access in the document section of ClinicalTrials.gov. No change in inclusion criteria were made. The only change was the introduction of those two questions described before. These updates are aimed at accommodating the presence of COVID-19 patients in the trial as the main subgroup of patients.
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Being tested
- High Flow Nasal Catheter, Noninvasive ventilation
- Keywords
- respiratory insufficiency, respiratory failure, non-invasive ventilation, high flow nasal cannula, nasal high flow, trans-nasal insufflation, NIV, HFNC
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CatheterDevice
Also called Optiflow, Airvo, trans-nasal insufflation, Nasal High Flow
HFNC will deliver through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees.
Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize patient´s comfort and SpO2.
Noninvasive ventilationDevice
Also called BiPAP, Non-invasive ventilation, Noninvasive positive pressure ventilation
NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 tailored to specific ARF subgroups, according to the protocol. Adjustments of the inspiratory pressure (IPAP) and expiratory pressure (EPAP) and FiO2 according to protocol
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Catheter | Experimental | The HFNC (AIRVO2 Fisher \& Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min. Receives: Device: High Flow Nasal Catheter |
| Non-invasive positive pressure ventilation | Active comparator | NIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or invasive mechanical ventilator with NIPPV mode are accepted. The interface should be a oronasal or full face mask. Receives: Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation rate or death
proportion of endotracheal intubation or death
Measured: in 7 days
Secondary outcomes (4)
Mortality
Death
Measured: in 28 days
Mortality
Death
Measured: in 90 days
ICU free days
Days out of ICU
Measured: in 28 days
IMV free days
Days without IMV inside of ICU after 48 hours of being extubated
Measured: in 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Nov 2019
- Primary completion30 Nov 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies 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
- Adaptive, non-inferiority randomized, open-label, controled clinical trial
- Masking
- None (open label)
- Enrolment
- 1,801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, Berry Consultants
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, Study chair, Research Institute - Hospital do Coracao, Sao Paulo, BrazilIsrael Maia, MD, Principal investigator, Research Institute - Hospital do Coracao, Sao Paulo, BrazilLeticia Kawano-Dourado, MD, Principal investigator, Research Institute - Hospital do Coracao, Sao Paulo, BrazilLaurent Brochard, MD, Study chair, St. Michael's Hospital (Toronto, Canada)Carlos R Carvalho, MD, Study chair, Pulmonary Division University of Sao Paulo, Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643939
- Sponsor's protocol ID
- RENOVATEmain_2018_08
- Acronym
- RENOVATE
- Status last verified
- May 2024
- First submitted
- 21 Aug 2018
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zampieri FG, Cavalcanti AB, Cahusac PMB, Kawano-Dourado L, Harhay MO, Maia IS. Sequential likelihood ratios and e-processes in the analysis of the RENOVATE trial. Ann Am Thorac Soc. 2026 Jun 1;23(6):941-950. doi: 10.1093/annalsats/aaoag042.
PubMed 41734013RENOVATE Investigators and the BRICNet Authors; Maia IS, Kawano-Dourado L, Tramujas L, de Oliveira NE, Souza RN, Signorini DF, Pincelli MP, Zandonai CL, Blasius RT, Freires F, Ferreira VM, Romano MLP, Miura MC, de Censo CM, Caser EB, Silva B, Santos Bonomo DC, Arraes JA, de Alencar Filho MS, Alvares Horta JG, Oliveira DC, Boschi E, Costa RL, Westphal GA, Ramos J, Lacerda FH, Filho CRH, Pinheiro BV, de Andrade Neumamm LB, Guimaraes Junior MRR, de Souza DT, Ferreira JC, Ohe LN, Schettini DA, Thompson MM, de Oliveira MCF, Veiga VC, Negrelli KL, Santos RHN, Damiani L, Gurgel RM, Gomes SPC, Lima LM, Miranda TA, Laranjeira LN, de Barros E Silva PGM, Machado FR, Fitzgerald M, Bosse A, Marion J, Carvalho CRR, Brochard L, Lewis RJ, Biasi Cavalcanti A. High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):875-890. doi: 10.1001/jama.2024.26244.
PubMed 39657981Maia IS, Kawano-Dourado L, Zampieri FG, Damiani LP, Nakagawa RH, Gurgel RM, Negrelli K, Gomes SPC, Paisani D, Lima LM, Santucci EV, Valeis N, Laranjeira LN, Lewis R, Fitzgerald M, Carvalho CRR, Brochard L, Cavalcanti AB; RENOVATE Investigators and the BRICNet. High flow nasal catheter therapy versus non-invasive positive pressure ventilation in acute respiratory failure (RENOVATE trial): protocol and statistical analysis plan. Crit Care Resusc. 2023 Oct 18;24(1):61-70. doi: 10.51893/2022.1.OA8. eCollection 2022 Mar 7.
PubMed 38046839
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandomizEd Adaptive Trial of High-Flow Nasal Oxygen Cannula Compared to Non-Invasive Ventilation for AcuTE Respiratory Failure
- ClinicalTrials.gov ID
- NCT03643939
- Acronym / sponsor ID
- RENOVATE / RENOVATEmain_2018_08
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Keywords
- respiratory insufficiency, respiratory failure, non-invasive ventilation, high flow nasal cannula, nasal high flow, trans-nasal insufflation, NIV, HFNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,801 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Berry Consultants
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 23 Aug 2018 (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.
RENOVATE study aims to investigate if the respiratory support device called High-Flow Nasal Oxygen Cannula (HFNC) acts similarly (non-inferior) to another respiratory support device called Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation in adult patients with Acute Respiratory Failure (ARF) from different causes. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is that, even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same beneficial effect of NIPPV while being easier tolerated, allowing patients to talk, eat and drink through mouth while on HFNC. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications.
[IMPORTANT NOTE] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.
Detailed description
RENOVATE will investigate if High-Flow Nasal Oxygen Cannula (HFNC) is non-inferior to Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation or death in adult patients with Acute Respiratory Failure (ARF) from different causes in 7 days. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. Even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC may have beneficial effect over NIPPV because it is easier to be tolerated, allowing patients to talk, eat and drink through mouth while on therapy. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. The main hypothesis is that HFNC is non inferior to NIPPV in reducing intubation rate or death within 7 days. However, as an adaptive study, this non inferiority hypothesis may change to superiority if gathered data during the study is promissing in the interim analysis. Therefore, sample size may increase to 2000 participants. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications.
[IMPORTANT NOTE] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.
Trial Update:
We have collected Covid 19 information since march 2020 as an added question in the CRF. There are two questions: one in the elegibility criteria form asking if Covid 19 is suspected and another one in the discharge form asking if Covid 19 was laboratory confirmed. Since then, there were considerably change in prevalence of acute respiratory failure subgroups since the beginning of the trial in 2019. Covid 19, nowdays, is responsible for 63% of our sample size, followed by hypoxemic non immunocompromised subgroup with 19%, acute pulmonary edema and hypoxemic immunocompromised with 8% and finally COPD with 2%. These prevalences are completely different from our previous assumptions in 2019 trial simulations as published in our protocol and statistical analysis plan in March 2022 Volume 24 Number 1 at Critical Care Resuscitation journal. Therefore, the Steering Committee decided that all Covid 19 patients, independent of previous subgroup allocation, would be analysed separately in a 5th subgroup. Update in simulations with different scenarios and new statistical models were done by March 13th 2023 to account for the 5th interim analysis which you can access in the document section of ClinicalTrials.gov. No change in inclusion criteria were made. The only change was the introduction of those two questions described before. These updates are aimed at accommodating the presence of COVID-19 patients in the trial as the main subgroup of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adaptive, non-inferiority randomized, open-label, controled clinical trial
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Catheter | Experimental | Device: High Flow Nasal CatheterThe HFNC (AIRVO2 Fisher \& Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min. |
| Non-invasive positive pressure ventilation | Active comparator | Device: Noninvasive ventilationNIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or invasive mechanical ventilator with NIPPV mode are accepted. The interface should be a oronasal or full face mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Indication of emergency ETI:
- Psychomotor agitation that prevents adequate medical / nursing care requiring heavy sedation
- Persistent hemodynamic instability with MAP <65 mmHg, SBP <90 mmHg after adequate volume resuscitation or requiring norepinephrine> 0.3 microg / kg / min or equivalent.
- Contraindications to non-invasive ventilation: face deformities or traumas, recent esophageal surgery, hypersecretion, vomiting with aspiration risk
- Presence of pneumothorax or extensive pleural effusion
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 CatheterAlso: Optiflow, Airvo, trans-nasal insufflation, Nasal High FlowHFNC will deliver through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees. Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize patient´s comfort and SpO2. | Device | High Flow Nasal Catheter |
| Noninvasive ventilationAlso: BiPAP, Non-invasive ventilation, Noninvasive positive pressure ventilationNIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 tailored to specific ARF subgroups, according to the protocol. Adjustments of the inspiratory pressure (IPAP) and expiratory pressure (EPAP) and FiO2 according to protocol | Device | Non-invasive positive pressure ventilation |
Primary outcome
Endotracheal intubation rate or death
Time frame: in 7 days
proportion of endotracheal intubation or death
4 secondary outcomes
Mortality
Time frame: in 28 days
Mortality
Time frame: in 90 days
ICU free days
Time frame: in 28 days
IMV free days
Time frame: in 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 20 May 2024.
- Derived from this study: PubMed 41734013Zampieri FG, Cavalcanti AB, Cahusac PMB, Kawano-Dourado L, Harhay MO, Maia IS. Sequential likelihood ratios and e-processes in the analysis of the RENOVATE trial. Ann Am Thorac Soc. 2026 Jun 1;23(6):941-950. doi: 10.1093/annalsats/aaoag042.
- Derived from this study: PubMed 39657981RENOVATE Investigators and the BRICNet Authors; Maia IS, Kawano-Dourado L, Tramujas L, de Oliveira NE, Souza RN, Signorini DF, Pincelli MP, Zandonai CL, Blasius RT, Freires F, Ferreira VM, Romano MLP, Miura MC, de Censo CM, Caser EB, Silva B, Santos Bonomo DC, Arraes JA, de Alencar Filho MS, Alvares Horta JG, Oliveira DC, Boschi E, Costa RL, Westphal GA, Ramos J, Lacerda FH, Filho CRH, Pinheiro BV, de Andrade Neumamm LB, Guimaraes Junior MRR, de Souza DT, Ferreira JC, Ohe LN, Schettini DA, Thompson MM, de Oliveira MCF, Veiga VC, Negrelli KL, Santos RHN, Damiani L, Gurgel RM, Gomes SPC, Lima LM, Miranda TA, Laranjeira LN, de Barros E Silva PGM, Machado FR, Fitzgerald M, Bosse A, Marion J, Carvalho CRR, Brochard L, Lewis RJ, Biasi Cavalcanti A. High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):875-890. doi: 10.1001/jama.2024.26244.
- Derived from this study: PubMed 38046839Maia IS, Kawano-Dourado L, Zampieri FG, Damiani LP, Nakagawa RH, Gurgel RM, Negrelli K, Gomes SPC, Paisani D, Lima LM, Santucci EV, Valeis N, Laranjeira LN, Lewis R, Fitzgerald M, Carvalho CRR, Brochard L, Cavalcanti AB; RENOVATE Investigators and the BRICNet. High flow nasal catheter therapy versus non-invasive positive pressure ventilation in acute respiratory failure (RENOVATE trial): protocol and statistical analysis plan. Crit Care Resusc. 2023 Oct 18;24(1):61-70. doi: 10.51893/2022.1.OA8. eCollection 2022 Mar 7.
- Individual participant dataSharing planned: Yes
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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.
Alexandre B Cavalcanti, MD study chair
Research Institute - Hospital do Coracao, Sao Paulo, Brazil
Israel Maia, MD principal investigator
Research Institute - Hospital do Coracao, Sao Paulo, Brazil
Leticia Kawano-Dourado, MD principal investigator
Research Institute - Hospital do Coracao, Sao Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Catheter and Noninvasive ventilation in people with Respiratory Insufficiency and Respiratory Failure, run by Hospital do Coracao at 1 site in Brazil.
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 0 inclusion and 24 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 20 May 2024. 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 Brazil. 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 rate or death (time frame: in 7 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 NCT03643939, which also lists 3 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 20 May 2024.