PoisoningPhase 3NICONCT04653597
Non-invasive Airway Management of Comatose Poisoned Emergency Patients
A Phase 3 study testing Close monitoring and Endotracheal intubation in people with Poisoning and Consciousness, Level Altered, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poisoning, Consciousness, Level Altered, Comatose
- What is being tested?
- Close monitoring and Endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2021to 12 Apr 2023
- Phase
- Phase 3
- 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
- Clinical suspicion of acute poisoning (either alcohol, drug or medication)
- Decreased level of consciousness with a GCS ≤ 8 assessed by an emergency physician either in the ED or in the out of hospital field with the mobile intensive care unit (MICU).
- Written informed consent signed by the patient / the trustworthy person / family member / close relative or inclusion in case of emergency
- Patients affiliated to French social security ("AME" excepted)
Who cannot join
- Respiratory failure (SpO2 < 90% with oxygen provided by nasal cannula (≤ 4 l/min.), clinical signs of respiratory distress)
- Sustained systolic blood pressure < 90 mmHg despite fluid resuscitation of 1 liter of critalloid
- Witnessed seizure
- Acute cerebral aggression (Traumatic brain injury, intracranial hematoma, stroke)
- Suspected Cardiotropic drugs poisoning (beta blockers, calcium channel inhibitor, angiotensin conversion enzyme), QRS or QT enlargement on ECG.
- Suspected sole intoxication with toxic for which there is an antidote
Show all 9Show fewer
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Known Pregnant women and breast feeding woman
- Participation in another intervention trial
Trial locations and contacts
1 site in 1 country.
About this study
A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended for patients with traumatic brain injury and coma, it remains unknown whether the benefit of an invasive management of airways with sedation, intubation and mechanical ventilation should be applied to other causes of coma in particular for acute poisoned patients. The investigator hypothesize that a conservative management with close monitoring without immediate endotracheal intubation of these patients is effective and associated with less in-hospital complications (truncated at 28 days) compared to routine practice management (in which the decision of immediate intubation is left to the discretion of the emergency physician).
Read the detailed description
A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of intensive care unit (ICU) admission). In France, approximately 165 000 poisoned patients are managed each year.1 Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness - a GCS ≤ 8 is associated with reduced gag reflex and increased incidence of aspiration pneumonia (with an adjusted odds ratio of 2.32, 95%CI =1.60 to 3.33). However, whether this risk of aspiration pneumonia (AP) may be decreased by early intubation is unknown, and no difference in the risk of AP was reported between patients that were intubated early and patients who were not.
Although it is well established that in trauma patients, a GCS ≤ 8 mandates airway management by endotracheal intubation, it remains unknown whether this strategy should be applied to other etiologies of coma, in particular for acute poisoned patients. Tracheal intubation and mechanical ventilation allow to prevent aspiration pneumonia, to optimize oxygenation and gas exchange.
Investigators will include patients with a decreased level of consciousness (defined by a GCS of 8 or less) caused by acute intoxication (alcohol, recreative drugs, or other prescription drugs (with the exception intoxication with cardiotropic drugs, e.g. beta blockers, calcium channel inhibitor, angiotensin conversion enzyme)). These patients will be included at the initial stage of their management: in the ED, or out of hospital with a pre-hospital emergency physician. Patients with clear proven benefit of intubation will be excluded : patients in shock, patients with suspicion of brain lesion, seizure related with poisoning, visualization of regurgitation of gastric content or sign of respiratory distress. Conservative airway management. Patients will be conservatively managed, i.e. close monitoring and no intubation and mechanical ventilation unless the patient presents a clinical event that needs intubation (shock, sign of respiratory distress, visualization of regurgitation or seizure).
Acute poisoning is a common reason for presentation to the ED or MICU intervention (up to 1% of all ED visits and 3% of intensive care unit (ICU) admission). These patients are often intubated (reported rate ranging from 20 to 50% in different cohort studies), when their GCS is below 8, in order to protect their airways. However there is currently no clear demonstration of its efficacy in this specific target population, while it is known that intubation is associated with morbidity and mortality.
Intubated patients need subsequent intensive care unit admission and invasive monitoring, and this can be associated with increased risk of pulmonary complications, length of hospital-stay, nosocomial infections and cost. In a context of expenditures control in health care, appropriate intensive care resource utilization is an important issue. When considering the increasing demand for intensive care among emergency patients, the importance of health care resource allocation and expenditure control, and the possible absence benefit of intubation and intensive care, an endotracheal airway management of poisoned coma patients might be detrimental.
Thus, if our hypothesis is demonstrated, the results of NICO study will change practice and guidelines for management of acute coma poisoned patients, with less exposure to the morbidity of endotracheal intubation and associated with decrease of ICU stay, and reduction of their health costs.
- Conditions
- Poisoning, Consciousness, Level Altered, Comatose
- Being tested
- Close monitoring, Endotracheal intubation
- Keywords
- ED, ICU, MICU, Coma, Comatose poisoning, intubation, Endotracheal intubation, GCS, Glasgow Coma Scale
- Medical subject headings
- Poisoning, Consciousness Disorders, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Close monitoringProcedure or surgery
surveillance every 30 minutes of blood pressure, SpO2, respiratory rate, heart rate and GCS until the patient recovers a GCS>8 or responds adequately to a simple order
Endotracheal intubationProcedure or surgery
invasive airway management in order to avoid risk of pulmonary aspiration
| Study group | Role | What they receive |
|---|---|---|
| Conservative airway management | Experimental | decision to intubate will be withheld as long as the patient's state allows it. The patient will be closely monitored and decision of intubation will be made upon presence of regurgitation, seizure, shock, or sign of respiratory distress. Receives: Procedure: Close monitoring |
| Routine practice | Other | decision of intubation left at the discretion of the emergency physician Receives: Procedure: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite endpoint of (truncated at 28 days): - In hospital death
this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.
Measured: at 28 days
Hierarchical composite endpoint of (truncated at 28 days):- Length of ICU stay
this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.
Measured: at 28 days
Hierarchical composite endpoint of (truncated at 28 days): - Length of hospital stay
this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.
Measured: at 28 days
Secondary outcomes (10)
In-hospital death (truncated at 28 days)
number of included patients dead at 28 days after randomisation
Measured: at 28 days
ICU length of stay (truncated at 28 days)
number of day in ICU for each patient included since randomization
Measured: at 28 days
Hospital length of stay (truncated at 28 days)
number of day in hospitalization for each patient included since their randomization
Measured: at 28 days
Proportion of patient with Mechanical ventilation at day 28
number of patient included with mechanical ventilation 28 days after randomization
Measured: at 28 days
Lenght of mechanical ventilation until hospital discharge or at day28
Measured: at 28 days
Proportion of ICU admission
number of patient included admitted to ICU during hospital stay
Measured: 28 days
Proportion of rapid onset pneumonia
number of patient included developing a rapid onset pneumonia during hospital stay
Measured: 28 days
Adverse events from intubation (hypoxemia, dental trauma, regurgitation, cardiac arrest, intubation difficulty score (IDS) ≥ 5, hypotension or esophageal intubation)
number of patient included developing an adverse events from intubation during hospital stay, and type of adverse events
Measured: 28 days
total hospital costs (truncated at 28 days)
cost of hospitalization for patient included in the study.
Measured: at 28 days
total hospital cost consequence analysis (truncated at 28 days)
cost of hospitalization for patient included in the study.
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start16 May 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PoisoningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonathan FREUND, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653597
- Sponsor's protocol ID
- APHP200013
- Other IDs
- 2020-A02036-33
- Acronym
- NICO
- Status last verified
- Jul 2023
- First submitted
- 9 Oct 2020
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siaha BFN, Ossima AN, Mimouni M, Freund Y, Durand-Zaleski I; NICO Study Group. Cost-effectiveness of non-invasive airway management of comatose patients with acute poisoning. Intensive Care Med. 2024 Jul;50(7):1169-1171. doi: 10.1007/s00134-024-07452-1. Epub 2024 Jun 24. No abstract available.
PubMed 38913094Freund Y, Viglino D, Cachanado M, Cassard C, Montassier E, Douay B, Guenezan J, Le Borgne P, Yordanov Y, Severin A, Roussel M, Daniel M, Marteau A, Peschanski N, Teissandier D, Macrez R, Morere J, Chouihed T, Roux D, Adnet F, Bloom B, Chauvin A, Simon T. Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial. JAMA. 2023 Dec 19;330(23):2267-2274. doi: 10.1001/jama.2023.24391.
PubMed 38019968
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Airway Management of Comatose Poisoned Emergency Patients
- ClinicalTrials.gov ID
- NCT04653597
- Acronym / sponsor ID
- NICO / APHP200013
- Conditions
- Poisoning, Consciousness, Level Altered, Comatose
- Keywords
- ED, ICU, MICU, Coma, Comatose poisoning, intubation, Endotracheal intubation, GCS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 May 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 4 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.
A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended for patients with traumatic brain injury and coma, it remains unknown whether the benefit of an invasive management of airways with sedation, intubation and mechanical ventilation should be applied to other causes of coma in particular for acute poisoned patients. The investigator hypothesize that a conservative management with close monitoring without immediate endotracheal intubation of these patients is effective and associated with less in-hospital complications (truncated at 28 days) compared to routine practice management (in which the decision of immediate intubation is left to the discretion of the emergency physician).
Detailed description
A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of intensive care unit (ICU) admission). In France, approximately 165 000 poisoned patients are managed each year.1 Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness - a GCS ≤ 8 is associated with reduced gag reflex and increased incidence of aspiration pneumonia (with an adjusted odds ratio of 2.32, 95%CI =1.60 to 3.33). However, whether this risk of aspiration pneumonia (AP) may be decreased by early intubation is unknown, and no difference in the risk of AP was reported between patients that were intubated early and patients who were not.
Although it is well established that in trauma patients, a GCS ≤ 8 mandates airway management by endotracheal intubation, it remains unknown whether this strategy should be applied to other etiologies of coma, in particular for acute poisoned patients. Tracheal intubation and mechanical ventilation allow to prevent aspiration pneumonia, to optimize oxygenation and gas exchange.
Investigators will include patients with a decreased level of consciousness (defined by a GCS of 8 or less) caused by acute intoxication (alcohol, recreative drugs, or other prescription drugs (with the exception intoxication with cardiotropic drugs, e.g. beta blockers, calcium channel inhibitor, angiotensin conversion enzyme)). These patients will be included at the initial stage of their management: in the ED, or out of hospital with a pre-hospital emergency physician. Patients with clear proven benefit of intubation will be excluded : patients in shock, patients with suspicion of brain lesion, seizure related with poisoning, visualization of regurgitation of gastric content or sign of respiratory distress. Conservative airway management. Patients will be conservatively managed, i.e. close monitoring and no intubation and mechanical ventilation unless the patient presents a clinical event that needs intubation (shock, sign of respiratory distress, visualization of regurgitation or seizure).
Acute poisoning is a common reason for presentation to the ED or MICU intervention (up to 1% of all ED visits and 3% of intensive care unit (ICU) admission). These patients are often intubated (reported rate ranging from 20 to 50% in different cohort studies), when their GCS is below 8, in order to protect their airways. However there is currently no clear demonstration of its efficacy in this specific target population, while it is known that intubation is associated with morbidity and mortality.
Intubated patients need subsequent intensive care unit admission and invasive monitoring, and this can be associated with increased risk of pulmonary complications, length of hospital-stay, nosocomial infections and cost. In a context of expenditures control in health care, appropriate intensive care resource utilization is an important issue. When considering the increasing demand for intensive care among emergency patients, the importance of health care resource allocation and expenditure control, and the possible absence benefit of intubation and intensive care, an endotracheal airway management of poisoned coma patients might be detrimental.
Thus, if our hypothesis is demonstrated, the results of NICO study will change practice and guidelines for management of acute coma poisoned patients, with less exposure to the morbidity of endotracheal intubation and associated with decrease of ICU stay, and reduction of their health costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative airway management | Experimental | Procedure: Close monitoringdecision to intubate will be withheld as long as the patient's state allows it. The patient will be closely monitored and decision of intubation will be made upon presence of regurgitation, seizure, shock, or sign of respiratory distress. |
| Routine practice | Other | Procedure: Endotracheal intubationdecision of intubation left at the discretion of the emergency physician |
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
- Clinical suspicion of acute poisoning (either alcohol, drug or medication)
- Decreased level of consciousness with a GCS ≤ 8 assessed by an emergency physician either in the ED or in the out of hospital field with the mobile intensive care unit (MICU).
- Written informed consent signed by the patient / the trustworthy person / family member / close relative or inclusion in case of emergency
- Patients affiliated to French social security ("AME" excepted)
Key exclusion criteria (9 listed)
- Respiratory failure (SpO2 < 90% with oxygen provided by nasal cannula (≤ 4 l/min.), clinical signs of respiratory distress)
- Sustained systolic blood pressure < 90 mmHg despite fluid resuscitation of 1 liter of critalloid
- Witnessed seizure
- Acute cerebral aggression (Traumatic brain injury, intracranial hematoma, stroke)
- Suspected Cardiotropic drugs poisoning (beta blockers, calcium channel inhibitor, angiotensin conversion enzyme), QRS or QT enlargement on ECG.
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 |
|---|---|---|
| Close monitoringsurveillance every 30 minutes of blood pressure, SpO2, respiratory rate, heart rate and GCS until the patient recovers a GCS>8 or responds adequately to a simple order | Procedure or surgery | Conservative airway management |
| Endotracheal intubationinvasive airway management in order to avoid risk of pulmonary aspiration | Procedure or surgery | Routine practice |
Primary outcome
Hierarchical composite endpoint of (truncated at 28 days): - In hospital death
Time frame: at 28 days
this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.
Hierarchical composite endpoint of (truncated at 28 days):- Length of ICU stay
Time frame: at 28 days
this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.
Hierarchical composite endpoint of (truncated at 28 days): - Length of hospital stay
Time frame: at 28 days
this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.
10 secondary outcomes
In-hospital death (truncated at 28 days)
Time frame: at 28 days
ICU length of stay (truncated at 28 days)
Time frame: at 28 days
Hospital length of stay (truncated at 28 days)
Time frame: at 28 days
Proportion of patient with Mechanical ventilation at day 28
Time frame: at 28 days
Lenght of mechanical ventilation until hospital discharge or at day28
Time frame: at 28 days
Proportion of ICU admission
Time frame: 28 days
Proportion of rapid onset pneumonia
Time frame: 28 days
Adverse events from intubation (hypoxemia, dental trauma, regurgitation, cardiac arrest, intubation difficulty score (IDS) ≥ 5, hypotension or esophageal intubation)
Time frame: 28 days
total hospital costs (truncated at 28 days)
Time frame: at 28 days
total hospital cost consequence analysis (truncated at 28 days)
Time frame: at 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 17 Jul 2023.
- Derived from this study: PubMed 38913094Siaha BFN, Ossima AN, Mimouni M, Freund Y, Durand-Zaleski I; NICO Study Group. Cost-effectiveness of non-invasive airway management of comatose patients with acute poisoning. Intensive Care Med. 2024 Jul;50(7):1169-1171. doi: 10.1007/s00134-024-07452-1. Epub 2024 Jun 24. No abstract available.
- Derived from this study: PubMed 38019968Freund Y, Viglino D, Cachanado M, Cassard C, Montassier E, Douay B, Guenezan J, Le Borgne P, Yordanov Y, Severin A, Roussel M, Daniel M, Marteau A, Peschanski N, Teissandier D, Macrez R, Morere J, Chouihed T, Roux D, Adnet F, Bloom B, Chauvin A, Simon T. Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial. JAMA. 2023 Dec 19;330(23):2267-2274. doi: 10.1001/jama.2023.24391.
- Individual participant dataSharing planned: Undecided
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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.
Yonathan FREUND, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Close monitoring and Endotracheal intubation in people with Poisoning and Consciousness, Level Altered, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 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 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hierarchical composite endpoint of (truncated at 28 days): - In hospital death (time frame: at 28 days). The study lists 3 primary outcomes in all. 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 NCT04653597, which also lists 2 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 17 Jul 2023.