Acute Respiratory Distress Syndrome (ARDS)Phase 1NCT02425579
Safety Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)
A Phase 1 study testing Inhaled Carbon Monoxide at 100ppm (4 participants) and Inhaled Carbon Monoxide at 200ppm (4 participants) in people with Acute Respiratory Distress Syndrome (ARDS), run by Brigham and Women's Hospital at 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Inhaled Carbon Monoxide at 100ppm (4 participants) and Inhaled Carbon Monoxide at 200ppm (4 participants)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2015to Aug 2019
- Phase
- Phase 1
- 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
- Patients with sepsis are defined as those with suspected or documented infection:
- Suspected or proven infection: Sites of infection include thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system
- All eligible patients meet the new definition of sepsis (suspected or proven infection and a SOFA ≥ 2) as PaO2/FiO2 ratio < 300 = 2 SOFA points.
- ARDS is defined when all four of the following criteria are met:
- A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
Show all 10Show fewer
- A need for positive pressure ventilation by an endotracheal or tracheal tube
- No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
- ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 120 hours.
- Infiltrates considered "consistent with pulmonary edema" include any infiltrates not fully explained by mass, atelectasis, or effusion or opacities known to be chronic (greater than 1 week). Vascular redistribution, indistinct vessels, and indistinct heart borders alone are not considered "consistent with pulmonary edema" and thus would not count as qualifying opacities for this study.
Who cannot join
- Age less than 18 years
- Greater than 120 hours since ARDS onset
- Pregnant or breast-feeding
- Prisoner
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- No consent/inability to obtain consent
Show all 23Show fewer
- Physician refusal to allow enrollment in the trial
- Moribund patient not expected to survive 24 hours
- No arterial line/no intent to place an arterial line
- No intent/unwillingness to follow lung protective ventilation strategy
- Severe hypoxemia defined as oxygenation saturation (SpO2) <95 or PaO2 <80 on FiO2 ≥0.8
- Hemoglobin < 7.5 g/dl or hemoglobin < 8 g/dl and actively bleeding
- Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
- Acute myocardial infarction (MI) or acute coronary syndrome (ACS) within the last 90 days
- Coronary artery bypass graft (CABG) surgery within 30 days
- Angina pectoris or use of nitrates with activities of daily living
- Cardiopulmonary disease classified as New York Heart Association (NYHA) class IV
- Stroke (ischemic or hemorrhagic) within the prior 3 months
- Diffuse alveolar hemorrhage from vasculitis
- Use of high frequency ventilation
- Participation in other interventional studies involving investigational agents
- Burns > 40% total body surface area
- Use of inhaled pulmonary vasodilator therapy (eg. NO or prostaglandins)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke Univesity Hospital
Durham, North Carolina, 27710
Weill Cornell Medical College/NewYork-Presbyterian
New York, New York, 10065
About this study
Official title: A Phase I Trial of Inhaled Carbon Monoxide for the Treatment of Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)
The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.
Read the detailed description
The acute respiratory distress syndrome (ARDS) is a syndrome of severe acute lung inflammation and hypoxemic respiratory failure with an incidence of 180,000 cases annually in the U.S.Despite decades of research and recent advances in lung protective ventilator strategies, morbidity and mortality remain unacceptably high. Furthermore, no specific effective pharmacologic therapies currently exist. The lack of specific effective therapies for sepsis-related ARDS indicates a need for new treatments that target novel pathways. Carbon monoxide (CO) represents a novel therapeutic modality in ARDS based on data obtained in experimental models of ARDS and sepsis over the past decade.
CO has been shown to be protective in experimental models of Acute Lung Injury (ALI), including hyperoxia and endotoxin exposure, bleomycin, ischemia/reperfusion, and ventilator-induced lung injury (VILI). At low doses, CO has been shown to confer tissue protective effects in these ALI models. In addition, CO has been shown to decrease inflammation, enhance phagocytosis, and improve mortality in models of sepsis including endotoxemia, hemorrhagic shock, and cecal ligation and puncture (CLP). CO has also been shown to have beneficial therapeutic effects in pre-clinical models of disease including pulmonary hypertension, vascular injury, and transplantation. Furthermore, multiple human studies have demonstrated that experimental administration of several different concentrations of CO is well tolerated and that low dose inhaled CO can be safely administered to subjects in a controlled research environment.
The purpose of this study is to assess the safety of inhaled CO therapy in mechanically ventilated patients with sepsis-induced ARDS.
- Being tested
- Inhaled Carbon Monoxide at 100ppm (4 participants), Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants), Inhaled Carbon Monoxide at 200ppm (4 participants), Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Carbon Monoxide at 100ppm (4 participants)Drug
Also called iCO
Inhaled Carbon Monoxide at 100ppm for up to 90 minutes daily for 5 days
Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)Drug
Also called Inhaled Medical Air
Inhaled Medical Air for up to 90 minutes daily for 5 days
Inhaled Carbon Monoxide at 200ppm (4 participants)Drug
Also called iCO
Inhaled Carbon Monoxide at 200ppm for 90 minutes daily for 5 days
Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)Drug
Also called Inhaled Medical Air
Inhaled Medical Air for up to 90 minutes daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Inhaled Carbon Monoxide at 100 ppm for up to 90 minutes daily for 5 days Receives: Drug: Inhaled Carbon Monoxide at 100ppm (4 participants) |
| Cohort 1 (placebo) | Placebo comparator | Inhaled Medical Air for up to 90 minutes daily for 5 days Receives: Drug: Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants) |
| Cohort 2 | Experimental | Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 5 days Receives: Drug: Inhaled Carbon Monoxide at 200ppm (4 participants) |
| Cohort 2 (Placebo) | Placebo comparator | Inhaled Medical Air for up to 90 minutes daily for 5 days Receives: Drug: Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of administration associated adverse events.
- Acute myocardial infarction (MI) within 48 hours of study drug administration
- Acute cerebrovascular accident (CVA) within 48 hours of study drug administration
- New onset atrial or ventricular arrhythmia requiring direct current (DC) cardioversion within 48 hours of study drug administration
- Increased oxygenation requirements defined as: an increase in fraction of inspired oxygen (FiO2) of greater than or equal to 0.2 AND increase in PEEP greater than or equal to 5 cm of water (H2O) within 6 hours of study drug administration
- Increase in any protocol-specified measurement of carboxyhemoglobin (COHb) greater than or equal to 10%
- Increase in lactate by greater than or equal to 2 mmol/L within 6 hours of study drug administration
Measured: 60 Days if remains in the ICU
Incidence of serious adverse events (SAEs).
An SAE is any event that is fatal or immediately life threatening, is permanently disabling, or severely incapacitating, or requires or prolongs inpatient hospitalization. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: 60 Days if remains in the ICU
Secondary outcomes (9)
Comparison between the calculated carboxyhemoglobin (COHb) level at 90 minutes using the Coburn-Forster-Kane (CFK) equation and measured COHb level at 90 minutes
The Coburn-Forster-Kane (CFK) equation will be used to calculate the estimated COHb level at 90 minutes for Cohorts 1 and 2.
Measured: 5 days
Mean daily Sequential Organ Failure Assessment (SOFA) score
Organ failure will be assessed using the SOFA score. SOFA scores will be assessed daily on days 1-5, and day 7, as the SOFA score has been shown to be a reliable prognostic indicator of outcomes in critically ill patients.
Measured: 7 days
Partial pressure of arterial oxygen (PaO2)/FiO2 ratio
PaO2/FiO2 will be measured daily on days 1-5 if a subject remains mechanically ventilated.
Measured: 5 days
Oxygenation index (OI)
The OI will be measured daily on days 1-5 if a subject remains mechanically ventilated.
Measured: 5 days
Lung injury score (LIS)
The LIS is a composite 4-point scoring system including the PaO2/FiO2, PEEP, quasi-static respiratory compliance, and the extent of infiltrates on the chest X-ray. Previous randomized clinical trials in ARDS have shown that a decreased LIS correlates with improvement in lung physiology as well as important clinical outcomes including mortality and ventilator-free days (VFDs).
Measured: 7 Days
Vasopressor-free days
Ventilator-free days will be assessed on day 28.
Measured: 28 days
Ventilator-free days (VFDs)
Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28.
Measured: 28 days
ICU-free days
ICU-free days will be assessed on day 28.
Measured: 28 days
Hospital-free days
Hospital-free days will be assessed on day 60.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Massachusetts General Hospital, Duke University
- Responsible party
- Principal investigator, Mark A. Perrella, M.D., Brigham and Women's Hospital
- Investigators
- Laura E Fredenburgh, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425579
- Sponsor's protocol ID
- 1408015437
- Status last verified
- Oct 2019
- First submitted
- 17 Mar 2015
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fredenburgh LE, Perrella MA, Barragan-Bradford D, Hess DR, Peters E, Welty-Wolf KE, Kraft BD, Harris RS, Maurer R, Nakahira K, Oromendia C, Davies JD, Higuera A, Schiffer KT, Englert JA, Dieffenbach PB, Berlin DA, Lagambina S, Bouthot M, Sullivan AI, Nuccio PF, Kone MT, Malik MJ, Porras MAP, Finkelsztein E, Winkler T, Hurwitz S, Serhan CN, Piantadosi CA, Baron RM, Thompson BT, Choi AM. A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. JCI Insight. 2018 Dec 6;3(23):e124039. doi: 10.1172/jci.insight.124039.
PubMed 30518685
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Inhaled Carbon Monoxide for the Treatment of Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT02425579
- Acronym / sponsor ID
- 1408015437
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Massachusetts General Hospital, Duke University
- Study start
- Apr 2015
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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 purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.
Detailed description
The acute respiratory distress syndrome (ARDS) is a syndrome of severe acute lung inflammation and hypoxemic respiratory failure with an incidence of 180,000 cases annually in the U.S.Despite decades of research and recent advances in lung protective ventilator strategies, morbidity and mortality remain unacceptably high. Furthermore, no specific effective pharmacologic therapies currently exist. The lack of specific effective therapies for sepsis-related ARDS indicates a need for new treatments that target novel pathways. Carbon monoxide (CO) represents a novel therapeutic modality in ARDS based on data obtained in experimental models of ARDS and sepsis over the past decade.
CO has been shown to be protective in experimental models of Acute Lung Injury (ALI), including hyperoxia and endotoxin exposure, bleomycin, ischemia/reperfusion, and ventilator-induced lung injury (VILI). At low doses, CO has been shown to confer tissue protective effects in these ALI models. In addition, CO has been shown to decrease inflammation, enhance phagocytosis, and improve mortality in models of sepsis including endotoxemia, hemorrhagic shock, and cecal ligation and puncture (CLP). CO has also been shown to have beneficial therapeutic effects in pre-clinical models of disease including pulmonary hypertension, vascular injury, and transplantation. Furthermore, multiple human studies have demonstrated that experimental administration of several different concentrations of CO is well tolerated and that low dose inhaled CO can be safely administered to subjects in a controlled research environment.
The purpose of this study is to assess the safety of inhaled CO therapy in mechanically ventilated patients with sepsis-induced ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Inhaled Carbon Monoxide at 100ppm (4 participants)Inhaled Carbon Monoxide at 100 ppm for up to 90 minutes daily for 5 days |
| Cohort 1 (placebo) | Placebo comparator | Drug: Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)Inhaled Medical Air for up to 90 minutes daily for 5 days |
| Cohort 2 | Experimental | Drug: Inhaled Carbon Monoxide at 200ppm (4 participants)Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 5 days |
| Cohort 2 (Placebo) | Placebo comparator | Drug: Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)Inhaled Medical Air for up to 90 minutes daily for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with sepsis are defined as those with suspected or documented infection:
- Suspected or proven infection: Sites of infection include thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system
- All eligible patients meet the new definition of sepsis (suspected or proven infection and a SOFA ≥ 2) as PaO2/FiO2 ratio < 300 = 2 SOFA points.
- ARDS is defined when all four of the following criteria are met:
- ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 120 hours.
Key exclusion criteria (23 listed)
- Age less than 18 years
- Greater than 120 hours since ARDS onset
- Pregnant or breast-feeding
- Prisoner
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
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 |
|---|---|---|
| Inhaled Carbon Monoxide at 100ppm (4 participants)Also: iCOInhaled Carbon Monoxide at 100ppm for up to 90 minutes daily for 5 days | Drug | Cohort 1 |
| Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)Also: Inhaled Medical AirInhaled Medical Air for up to 90 minutes daily for 5 days | Drug | Cohort 1 (placebo) |
| Inhaled Carbon Monoxide at 200ppm (4 participants)Also: iCOInhaled Carbon Monoxide at 200ppm for 90 minutes daily for 5 days | Drug | Cohort 2 |
| Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)Also: Inhaled Medical AirInhaled Medical Air for up to 90 minutes daily for 5 days | Drug | Cohort 2 (Placebo) |
Primary outcome
Number of administration associated adverse events.
Time frame: 60 Days if remains in the ICU
1. Acute myocardial infarction (MI) within 48 hours of study drug administration 2. Acute cerebrovascular accident (CVA) within 48 hours of study drug administration 3. New onset atrial or ventricular arrhythmia requiring direct current (DC) cardioversion within 48 hours of study drug administration 4. Increased oxygenation requirements defined as: an increase in fraction of inspired oxygen (FiO2) of greater than or equal to 0.2 AND increase in PEEP greater than or equal to 5 cm of water (H2O) within 6 hours of study drug administration 5. Increase in any protocol-specified measurement of carboxyhemoglobin (COHb) greater than or equal to 10% 6. Increase in lactate by greater than or equal to 2 mmol/L within 6 hours of study drug administration
Incidence of serious adverse events (SAEs).
Time frame: 60 Days if remains in the ICU
An SAE is any event that is fatal or immediately life threatening, is permanently disabling, or severely incapacitating, or requires or prolongs inpatient hospitalization. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
9 secondary outcomes
Comparison between the calculated carboxyhemoglobin (COHb) level at 90 minutes using the Coburn-Forster-Kane (CFK) equation and measured COHb level at 90 minutes
Time frame: 5 days
Mean daily Sequential Organ Failure Assessment (SOFA) score
Time frame: 7 days
Partial pressure of arterial oxygen (PaO2)/FiO2 ratio
Time frame: 5 days
Oxygenation index (OI)
Time frame: 5 days
Lung injury score (LIS)
Time frame: 7 Days
Vasopressor-free days
Time frame: 28 days
Ventilator-free days (VFDs)
Time frame: 28 days
ICU-free days
Time frame: 28 days
Hospital-free days
Time frame: 60 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 Oct 2019.
- Derived from this study: PubMed 30518685Fredenburgh LE, Perrella MA, Barragan-Bradford D, Hess DR, Peters E, Welty-Wolf KE, Kraft BD, Harris RS, Maurer R, Nakahira K, Oromendia C, Davies JD, Higuera A, Schiffer KT, Englert JA, Dieffenbach PB, Berlin DA, Lagambina S, Bouthot M, Sullivan AI, Nuccio PF, Kone MT, Malik MJ, Porras MAP, Finkelsztein E, Winkler T, Hurwitz S, Serhan CN, Piantadosi CA, Baron RM, Thompson BT, Choi AM. A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. JCI Insight. 2018 Dec 6;3(23):e124039. doi: 10.1172/jci.insight.124039.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrome (ARDS)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
Laura E Fredenburgh, MD principal investigator
Brigham and Women's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled Carbon Monoxide at 100ppm (4 participants) and Inhaled Carbon Monoxide at 200ppm (4 participants) in people with Acute Respiratory Distress Syndrome (ARDS), run by Brigham and Women's Hospital at 4 sites in United States.
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 10 inclusion and 23 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of administration associated adverse events. (time frame: 60 Days if remains in the ICU). The study lists 2 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 NCT02425579, which also lists 1 linked publication.
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 Oct 2019.