Acute Lung InjuryNCT03212690

Study of Renin-angiotensin System in Mechanically Ventilated Subjects

A study testing Mechanical ventilation in people with Acute Lung Injury, run by GlaxoSmithKline at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Lung Injury
What is being tested?: Mechanical ventilation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 2 sitesFrance
Study dates: 11 Jun 2018to 8 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subject must be 18 to 80 years of age inclusive, at the time of enrolment.
Subjects who are receiving invasive mechanical ventilation (duration of ventilation less than equal to 48 hours).
Body mass index within the range 18.0 - 38.0 kilograms per meter square (kg/m^2, inclusive). Clinical estimate of height and weight is acceptable.
Given subjects will be mechanically ventilated upon enrolment, obtaining informed consent directly from the subjects will not be feasible. Consent will be obtained by subject's Legally Acceptable Representative (LAR) or subject will be enrolled upon emergency consent process or subject will be enrolled by signing the informed consent.

Who cannot join

Subjects who are moribund or whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the 3 days of observation in the study.
Subjects undergoing elective surgery. Investigator will make every effort to ensure that the following exclusion criteria are met; however, in some instances it may not be possible to assess all of these criteria within the 48-hour window. In this case, a subject can be included and investigator will obtain the information when available.
Chronic obstructive pulmonary disease (COPD) requiring long term oxygen treatment or home mechanical ventilation.
Documented pre-existing chronic pulmonary hypertension.
Massive pulmonary embolism (defined by pulmonary embolism with systemic hypotension [defined as a systolic arterial pressure less than 90 mmHg or a drop in systolic arterial pressure of at least 40 mmHg for at least 15 minutes (mins)] which is not caused by new onset arrhythmias) or shock (manifested by evidence of tissue hypo-perfusion and hypoxia, including an altered level of consciousness, oliguria, or cool, clammy extremities).
Pulmonary vasculitis or pulmonary hemorrhage including diffuse alveolar hemorrhage.

Show all 10Show fewer

Lung transplantation within last 6 months.
Cardiopulmonary arrest during concurrent illness.
Any use of RAS modulators including Angiotensin Converting Enzyme (ACE) type 1 inhibitors, Renin inhibitors and Angiotensin Receptor Blockers within 4 days or 5.5 half live whichever is longer.
Do not resuscitate status.

Trial locations and contacts

2 sites in 1 country.

France2 sites

GSK Investigational Site
Boulogne-Billancourt, 92100
GSK Investigational Site
Créteil, 94000

Other trials in France

About this study

Official title: Study to Elucidate the Association of the Renin-angiotensin System and Right Ventricular Function in Mechanically Ventilated Patients

The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7) levels are associated with right ventricular (RV) dysfunction in mechanically ventilated subjects. It is also designed to further characterize the subject population for severity of RV dysfunction. This study will investigate the association of renin-angiotensin system (RAS) peptides and markers of RV function, as measured by echocardiography, in subjects requiring acute mechanical ventilation. Maximum 150 subjects will be enrolled for the study and they will be evaluated over three days period using standard of care investigations, including trans-thoracic echocardiography (TTE) and/or trans-esophageal echocardiography (TOE) echocardiography. The maximum total duration of this study for subjects is 28 days.

Conditions: Acute Lung Injury
Being tested: Local standard of care, Mechanical ventilation
Keywords: mechanical ventilation, echocardiography, right ventricular function, Ang (1-7), Ang II, Renin-angiotensin system
Medical subject headings: Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Local standard of careDrug
Local standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.
Mechanical ventilationProcedure or surgery
Mechanical ventilation will be based on volume-assist control mode, with a target tidal volume of 6-8 milliliter per kg (mL/kg) and a target plateau pressure of 30 centimeter of water (cmH2O).

Study groups in NCT03212690
Study group	Role	What they receive
Mechanically ventilated subjects	Experimental	Subjects receiving invasive mechanical ventilation (Duration of ventilation <=48 hours) will be evaluated using standard care investigations. Receives: Drug: Local standard of care; Procedure: Mechanical ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. Evaluable Population consisted of all participants for whom pulmonary arterial systolic pressure (PASP), ratio of right ventricular to left ventricular end-diastolic area (RV size ratio), Ang II and Ang(1-7) data have been recorded for at least one study time point, and who did not retrospectively withdraw the consent.
Measured: Days 1, 2 and 3
Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio)
Right ventricular size ratio was measured using TTE or TOE.
Measured: Days 1, 2 and 3
Number of Participants With Paradoxical Septal Motion
Paradoxical septal motion is the systolic movement of the interventricular septum toward the RV despite normal thickening. Paradoxical septal motion was measured by TTE or TOE. Number of participants who had paradoxical septal motion have been reported.
Measured: Days 1, 2 and 3
Pulmonary Arterial Systolic Pressure at Indicated Time Points
Pulmonary arterial systolic pressure was measured using TTE or TOE.
Measured: Days 1, 2 and 3
Right Atrial Pressure at Indicated Time Points
Right atrial pressure is the blood pressure in the right atrium of the heart. Right atrial pressure was measured by TTE or TOE.
Measured: Days 1, 2 and 3
Inferior Vena Cava Diameter at End Expiration at Indicated Time Points
Inferior vena cava diameter was measured using TTE or TOE. Pulmonary arterial systolic pressure was estimated from trans-tricuspid pressure and right atrial pressure or inferior vena cava diameter.
Measured: Days 1, 2 and 3
Pearson Correlation Coefficient Between PASP and Ang II Level
Pearson correlation coefficient between PASP and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using Statistical Analysis Software (SAS).
Measured: Up to Day 3
Pearson Correlation Coefficient Between RV Size Ratio and Ang II Level
Pearson correlation coefficient between RV size ratio and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Measured: Up to Day 3

Secondary outcomes (9)

Number of Participants With Pulmonary Circulatory Dysfunction
Pulmonary circulatory dysfunction is defined as moderate dysfunction (pulmonary arterial systolic pressure [>40 millimeters of mercury] or a dilated RV end diastolic RV/left ventricle [LV] area ratio [>=0.6] but without septal dyskinesia). At risk Population consisted of participants who satisfied following criteria: 1. pulmonary arterial systolic pressure and ratio of RV to LV end-diastolic area recorded for all three study days [regardless of the Ang II and Ang(1-7) status] and/or; 2. databased acute cor pulmonale/pulmonary circulatory dysfunction and/or acute respiratory distress syndrome (ARDS) assessment during the study period (even if they do not have three days worth of study assessments for the echo outcomes) were evaluated for acute cor pulmonale/pulmonary circulatory dysfunction and ARDS incidence rates. Number of participants with Pulmonary Circulatory Dysfunction have been reported.
Measured: Days 1, 2 and 3
Number of Participants With Acute Cor Pulmonale
Acute cor pulmonale is defined as a dilated RV in the mid-esophagus longitudinal view or apical 4-chamber view (end-diastolic RV/LV area ratio [0.6]) associated with the presence of a septal dyskinesia in the (transgastric) short-axis view of the heart. Number of participants with acute cor pulmonale have been reported.
Measured: Days 1, 2 and 3
Number of Participants With Severe Acute Cor Pulmonale
Severe acute cor pulmonale is defined as severely dilated RV (end-diastolic RV/LV area ratio >=1) with septal dyskinesia. Number of participants with severe acute cor pulmonale have been reported.
Measured: Days 1, 2 and 3
Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points.
Measured: Days 1, 2 and 3
Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points.
Measured: Days 1, 2 and 3
Pearson Correlation Coefficient Between PASP and Ang(1-7)
Pearson correlation coefficient between PASP and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Measured: Up to Day 3
Pearson Correlation Coefficient Between PASP and Ang II/Ang(1-7)
Pearson correlation coefficient between PASP and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Measured: Up to Day 3
Pearson Correlation Coefficient Between RV Size Ratio and Ang(1-7)
Pearson correlation coefficient between RV size ratio and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Measured: Up to Day 3
Pearson Correlation Coefficient Between RV Size Ratio and Ang II/Ang(1-7)
Pearson correlation coefficient between RV size ratio and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Measured: Up to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 20188 Jul 2019

First posted11 Jul 2017
Study start11 Jun 2018
Primary completion8 Jul 2019
Study completion8 Jul 2019

Why it stopped: Study stopped early following termination of associated clinical development program (due to lack of efficacy)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03212690
Sponsor's protocol ID: 205821
Other IDs: 2017-A01653-50
Status last verified: Mar 2020
First submitted: 6 Jul 2017
Last updated: 1 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Lung Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Elucidate the Association of the Renin-angiotensin System and Right Ventricular Function in Mechanically Ventilated Patients
ClinicalTrials.gov ID: NCT03212690
Acronym / sponsor ID: 205821
Conditions: Acute Lung Injury
Keywords: mechanical ventilation, echocardiography, right ventricular function, Ang (1-7), Ang II, Renin-angiotensin system
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped early following termination of associated clinical development program (due to lack of efficacy)
Enrolment: 57 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Jun 2018 (actual)
Primary completion: 8 Jul 2019 (actual)
Study completion: 8 Jul 2019 (actual)
First posted: 11 Jul 2017 (actual)
Results: Posted 1 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mechanically ventilated subjects	Experimental	Drug: Local standard of care, Procedure: Mechanical ventilationSubjects receiving invasive mechanical ventilation (Duration of ventilation <=48 hours) will be evaluated using standard care investigations.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female subject must be 18 to 80 years of age inclusive, at the time of enrolment.
Subjects who are receiving invasive mechanical ventilation (duration of ventilation less than equal to 48 hours).
Body mass index within the range 18.0 - 38.0 kilograms per meter square (kg/m^2, inclusive). Clinical estimate of height and weight is acceptable.
Given subjects will be mechanically ventilated upon enrolment, obtaining informed consent directly from the subjects will not be feasible. Consent will be obtained by subject's Legally Acceptable Representative (LAR) or subject will be enrolled upon emergency consent process or subject will be enrolled by signing the informed consent.

Key exclusion criteria (10 listed)

Subjects who are moribund or whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the 3 days of observation in the study.
Subjects undergoing elective surgery. Investigator will make every effort to ensure that the following exclusion criteria are met; however, in some instances it may not be possible to assess all of these criteria within the 48-hour window. In this case, a subject can be included and investigator will obtain the information when available.
Chronic obstructive pulmonary disease (COPD) requiring long term oxygen treatment or home mechanical ventilation.
Documented pre-existing chronic pulmonary hypertension.
Massive pulmonary embolism (defined by pulmonary embolism with systemic hypotension [defined as a systolic arterial pressure less than 90 mmHg or a drop in systolic arterial pressure of at least 40 mmHg for at least 15 minutes (mins)] which is not caused by new onset arrhythmias) or shock (manifested by evidence of tissue hypo-perfusion and hypoxia, including an altered level of consciousness, oliguria, or cool, clammy extremities).

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
Local standard of careLocal standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.	Drug	Mechanically ventilated subjects
Mechanical ventilationMechanical ventilation will be based on volume-assist control mode, with a target tidal volume of 6-8 milliliter per kg (mL/kg) and a target plateau pressure of 30 centimeter of water (cmH2O).	Procedure or surgery	Mechanically ventilated subjects

Primary outcome

Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level
Time frame: Days 1, 2 and 3
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. Evaluable Population consisted of all participants for whom pulmonary arterial systolic pressure (PASP), ratio of right ventricular to left ventricular end-diastolic area (RV size ratio), Ang II and Ang(1-7) data have been recorded for at least one study time point, and who did not retrospectively withdraw the consent.
Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio)
Time frame: Days 1, 2 and 3
Right ventricular size ratio was measured using TTE or TOE.
Number of Participants With Paradoxical Septal Motion
Time frame: Days 1, 2 and 3
Paradoxical septal motion is the systolic movement of the interventricular septum toward the RV despite normal thickening. Paradoxical septal motion was measured by TTE or TOE. Number of participants who had paradoxical septal motion have been reported.
Pulmonary Arterial Systolic Pressure at Indicated Time Points
Time frame: Days 1, 2 and 3
Pulmonary arterial systolic pressure was measured using TTE or TOE.
Right Atrial Pressure at Indicated Time Points
Time frame: Days 1, 2 and 3
Right atrial pressure is the blood pressure in the right atrium of the heart. Right atrial pressure was measured by TTE or TOE.
Inferior Vena Cava Diameter at End Expiration at Indicated Time Points
Time frame: Days 1, 2 and 3
Inferior vena cava diameter was measured using TTE or TOE. Pulmonary arterial systolic pressure was estimated from trans-tricuspid pressure and right atrial pressure or inferior vena cava diameter.
Pearson Correlation Coefficient Between PASP and Ang II Level
Time frame: Up to Day 3
Pearson correlation coefficient between PASP and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using Statistical Analysis Software (SAS).
Pearson Correlation Coefficient Between RV Size Ratio and Ang II Level
Time frame: Up to Day 3
Pearson correlation coefficient between RV size ratio and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.

9 secondary outcomes

Number of Participants With Pulmonary Circulatory Dysfunction
Time frame: Days 1, 2 and 3
Number of Participants With Acute Cor Pulmonale
Time frame: Days 1, 2 and 3
Number of Participants With Severe Acute Cor Pulmonale
Time frame: Days 1, 2 and 3
Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level
Time frame: Days 1, 2 and 3
Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio
Time frame: Days 1, 2 and 3
Pearson Correlation Coefficient Between PASP and Ang(1-7)
Time frame: Up to Day 3
Pearson Correlation Coefficient Between PASP and Ang II/Ang(1-7)
Time frame: Up to Day 3
Pearson Correlation Coefficient Between RV Size Ratio and Ang(1-7)
Time frame: Up to Day 3
Pearson Correlation Coefficient Between RV Size Ratio and Ang II/Ang(1-7)
Time frame: Up to Day 3

Results and safety

Results posted to the registry on 1 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mechanically Ventilated Participants	57	56

Primary outcome: Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level

Time frame: Days 1, 2 and 3. Mean (Standard Deviation). Unit: Picograms per milliliter

Measure	Mechanically Ventilated Participants n = 44
Day 1, n=44	41.693 (67.4893)
Day 2, n=43	43.861 (110.6191)
Day 3, n=35	27.801 (49.1054)

Population analysed: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Primary outcome: Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio)

Time frame: Days 1, 2 and 3. Mean (Standard Deviation). Unit: Ratio

Measure	Mechanically Ventilated Participants n = 45
Day 1, n=45	0.653 (0.2418)
Day 2, n=42	0.655 (0.2276)
Day 3, n=35	0.634 (0.1662)

Population analysed: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Primary outcome: Number of Participants With Paradoxical Septal Motion

Time frame: Days 1, 2 and 3. Count of participants. Unit: Participants

Measure	Mechanically Ventilated Participants n = 43
Day 1, n=43	5
Day 2, n=41	11
Day 3, n=34	10

Population analysed: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Primary outcome: Pulmonary Arterial Systolic Pressure at Indicated Time Points

Time frame: Days 1, 2 and 3. Mean (Standard Deviation). Unit: Millimeters of mercury

Measure	Mechanically Ventilated Participants n = 39
Day 1, n=38	36.350 (15.7070)
Day 2, n=39	35.564 (12.2985)
Day 3, n=29	37.224 (13.3521)

Population analysed: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were collected up to Day 3. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mechanically Ventilated Participants	0 of 57 (0%)	0 of 57 (0%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical ventilation in people with Acute Lung Injury, run by GlaxoSmithKline at 2 sites 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level (time frame: Days 1, 2 and 3). The study lists 8 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 NCT03212690.

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 1 Apr 2020.