Acute Respiratory Distress SyndromeEXODUSNCT02550600
Extracorporeal Lung Assist Device in Acute Lung Impairment
A study testing iLA activve treatment in people with Acute Respiratory Distress Syndrome, run by Technical University of Munich at 8 sites in 4 countries.
Trial summary
The purpose of this study is to compare the effect of interventional Lung Assist iLA activve to standard therapy in mechanically ventilated patients with severe acute lung impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- iLA activve treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2015to Dec 2017
- 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
- Potentially reversible lung failure AND
- Cumulative Murray score ≥6 points without radiological points for a maximum of 48h AND
- Cumulative Murray score ≥4 points for pO2/FiO and PEEP AND
- Cumulative Murray score ≥1 point for pO2/FiO
- Mechanical ventilation for ≤96h AND
- Age ≥ 18 years.
Who cannot join
- SOFA-Score >20
- Life expectancy <24h
- mechanical ventilation >96h
- Heparin-induced thrombopenia
- Intracranial bleeding
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany5 sites
Klinik für Intensivmedizin; Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, D-20246
Stefan Kluge, MD, ++49-40-7410-57010, s.kluge@uke.de
Bernd Saugel, MD, ++49-40-7410-52415, b.saugel@uke.de
II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München
München, D-81675
Wolfgang Huber, MD, ++49-89-4140-5214, Wolfgang.Huber@lrz.tum.de
Regina Sommer, Study Nurse, ++49-89-4140-5478, Regina.Sommer@lrz.tum.de
Klinik für Anästhesiologie; Klinikum rechts der Isar; Technische Universität München
München, D-81675
Ralf Bogdanski, MD, ++49-89-4140-5472, r.bogdanski@lrz.tu-muenchen.de
Abteilung für Intensivmedizin; Krankenhaus Barmherzige Brüder; München
Munich, D-80639
Franz Brettner, MD, ++49-89-1797-2218, franz.brettner@barmherzige-muenchen.de
I. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München
Munich, D-81675
Petra Hoppmann, MD, ++49-89-4140-9670, Petra.Hoppmann@mri.tum.de
Juliane Jaitner, MD, ++49-89-4140-2367, Juliane.Jaitner@gmx.de
Austria1 site
Medical University of Vienna/General Hospital of Vienna
Vienna
Thomas Staudinger, MD, ++43-01-40400-44920, thomas.staudinger@meduniwien.ac.at
Hungary1 site
Department of Anaesthesiology and Intensive Therapy; University of Szeged
Szeged
Zsolt Molnar, MD, z_molnar@hotmail.com
Eva Zollei, MD
United Kingdom1 site
St. Bartholomew's & London Chest Hospitals
London
Benjamin O´Brien, MD; PhD
Sibtain Anwar, MD
About this study
Official title: EXODUS: Extracorporeal Lung Assist Device in Acute Lung Impairment: A Randomized Controlled Study
The purpose of this study is to compare the effect of interventional Lung Assist iLA activve to standard therapy in mechanically ventilated patients with severe acute lung impairment. Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or death) within 28 days compared to standard treatment.
Read the detailed description
Background:
Mechanical ventilation in patients with acute lung impairment further injures the lungs by inspiration forces and inflammatory response. Large efforts have been invested in reducing ventilator-associated lung damage by lower tidal volumes. However, benefits are limited by potential harms of permissive hypercapnia.
Therefore, extracorporeal membrane oxygenation (ECMO) and CO2-removal have been studied for more than 40 years. However, ECMO remained restricted to few specialized centres capable to provide extensive resources. Transfer of patients implicates loss of time and risks of transportation. Therefore, less invasive devices have been developed, including "pump-less "extracorporeal lung assist" (pECLA) and pump-driven ECLA (e.g. iLA activve). Despite pilot trials supporting feasibility, safety and efficient oxygenation and decarboxylation by pump-driven ECLA, there are no randomized controlled trials (RCT) proving a benefit regarding long-term endpoints.
Objectives:
Therefore, the aim of this multicentre RCT is to compare the outcome of 150 patients with early (after ≤96h of mechanical ventilation) acute lung impairment treated by pump-driven ECLA with iLA activve with a blood flow of at least 1L/min vs. 150 controls with standard intensive care including low tidal volume ventilation.
Main inclusion and exclusion criteria:
While most trials on ECMO and (p)ECLA included patients in a rescue scenario with severe and persisting ARDS, earlier inclusion also implicates modified inclusion criteria: A cumulative Murray score of ≥6 points without radiological points is the most important inclusion criterion. At least four points must result from pO2/FiO2 (mandatory pO2/FiO2<300mmHg) and PEEP criteria of the Murray score. In order to provide sufficient time for conservative attempts to optimize ventilation, inclusion criteria can be fulfilled for a maximum of 48h before inclusion as long as the patient can be included within a maximum of 96h of mechanical ventilation.
Primary efficacy endpoint:
Incidence of an increase in SOFA-Score ≥3 points or death within 28 days.
Statistical analyses:
Generalized linear mixed model (logit link function) will be used to compare the primary efficacy endpoint, the proportion of patients with an increase in SOFA of ≥3 points or death within 28d, between the two groups. In this analysis the random factor variable study centre and anticoagulation therapy will be considered as adjustment variables. The test of group effect estimated by the multivariable mixed logistic model will be conducted at a two-sided 0.05 level of significance.
The primary efficacy analysis will be based on the intention-to-treat population. Missing values of SOFA score will be replaced by last-value carry forward approach.
Survival status of lost to follow-up patients will be replaced conservatively: missing survival status will be replaced by attribute "death" for patients in the verum arm and replaced by attribute "alive" for patients in the standard treatment arm.
A supportive complete case and per-protocol analysis will be conducted for purpose of sensitivity analysis of the primary endpoint. Further sensitivity analyses will be provided to evaluate robustness of results in regard to unexpected circumstances (e.g. impact of 'cross-over' patients who are not treated as randomized but are required to be analyzed as randomized (ITT-principle)). Secondary endpoints will be analyzed in an exploratory manner.
Chi-Square test or Fisher-exact test will be used to compare categorical data. For comparisons of continuous data between groups non-parametric tests (Kruskal-Wallis test, Mann-Whitney-U test) will be performed. 95% confidence intervals will be calculated for relevant measurements. SAS software (version 4.9 or future follow-up version).
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- iLA activve treatment, Control group
- Keywords
- ARDS, Acute lung impairment, Extracorporeal lung assist, ECMO, ECLA, Murray-score, SOFA-score
- 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.
iLA activve treatmentProcedure or surgery
Also called ECMO, Extra-corporeal lung assist
iLA activve is aimed at efficient extracorporeal membrane oxygenation with an initial blood flow of ≥2L/min. The length of therapy is at the discretion of the treating physician.
Treating physicians are recommended to use a pre-specified algorithm to optimize the extracorporeal lung assist (choice of cannulas and oxygenator, titration of blood flow and sweep gas flow). Primary/mandatory goals are pO2≥65mmHg, P_peak ≤30cm H2O, TV ≤6ml/kg PBW and pH ≥7.25. Secondary suggested goals are setting the PEEP level within the limits suggested by the ARDSnet low and high PEEP strategy, 35mmHg ≤ pCO2 ≤45mmHg, Delta-pressure (= P_peak - PEEP) ≤15 cm H2O and P_peak ≤25 cm H2O.
iLA activve treatment also requires anticoagulation with un-fractionized heparin (PTT-goal 45s-60s depending on blood flow).
Control groupProcedure or surgery
The controls will be treated according to the recent guideline of the German Sepsis Society and the German Interdisciplinary Association of Intensive Care and Emergency Medicine and good clinical practice including lung-protective ventilation with low tidal volume (LTV), moderate hypercapnia, PEEP according to ARDSnet, adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) and treatment of the underlying disease as applied in the experimental group.
There will be no sham treatment of iLA activve.in the controls. All adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) are also available for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention: iLA activve treatment. iLA activve treatment also requires anticoagulation with un-fractionized heparin and pre-defined PTT-goals (45s-60s depending on blood flow). Receives: Procedure: iLA activve treatment |
| Control group | Active comparator | Controls: standard care according to good clinical practice and recent guidelines; no extracorporeal lung assist.
For ethical reasons patients of the control group can be treated with iLA activve after fulfilling the primary endpoint criterium of an increase in SOFA ≥3 points. These cross-over patients will be analyzed as controls ("intention to treat"). Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of an increase in SOFA-Score ≥3 points or death within 28 days
Measured: 28 days
Secondary outcomes (12)
Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone
Measured: 6 months
Mortality
Measured: 28 days, 60 days, ICU-stay
Ventilator free days
Measured: 28 days, ICU stay
Single organ failures as assessed by SOFA
Measured: 28 days, ICU stay
Prediction of outcome (Primary endpoint: Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)
Uni- and multivariate analysis of the predictive capabilities of baseline values of extravascular lung water index and graduation of ARDS (AECC- and Berlin definition of ARDS, Murray-score)
Measured: 28 days
Safety analysis assessed by documentation of complications and side effects potentially related to iLA activve and/or conventional therapy including complications associated to cannulation and extracorporeal circuit,
thrombosis, pulmonary embolism, pneumothorax, use of tube thoracostomies
Measured: 6 months
Meta-analysis
Meta-analysis of this study and other high-quality RCTs on extracorporeal lung Support regarding survival to 6 months without disability, all cause mortality on day 60.
Measured: 6 months
Resource use and economic outcomes
Comparison of resource use based on DRG-calculation
Measured: 6 months
Early vs. late intervention
Comparison of outcome of patients with early iLA activve (Intervention group) to late iLA activve (Control group with cross-over): survival to 6 months without disability, mortality after 28 days, 60 days and 6 months.
Measured: 6 months
Prediction of outcome (Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone)
Uni- and multivariate analysis of the predictive capabilities of baseline values of extravascular lung water index and graduation of ARDS (AECC- and Berlin definition of ARDS, Murray-score)
Measured: 6 months
Association of the fluid balance to the primary endpoint (Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)
Uni- and multivariate analysis regarding the association of the cumulative fluid balance with the primary endpoint
Measured: 28 days
Association of the fluid balance to the secondary endpoint "death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone)"
Uni- and multivariate analysis regarding the association of the cumulative fluid balance with the secondary endpoint
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Novalung GmbH, Heilbronn, Germany, Studiensekretariat Intensivmedizin; II. Medizinische Klinik; Klinikum rechts der Isar; Munich
- Responsible party
- Sponsor
- Investigators
- Wolfgang Huber, MD, Principal investigator, II. Medizinische Klinik; Klinikum rechts der Isar; Ismaningerstrasse 22; D-81675 München; Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550600
- Sponsor's protocol ID
- EXO_1
- Acronym
- EXODUS
- Status last verified
- Sep 2015
- First submitted
- 24 Jul 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXODUS: Extracorporeal Lung Assist Device in Acute Lung Impairment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02550600
- Acronym / sponsor ID
- EXODUS / EXO_1
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Acute lung impairment, Extracorporeal lung assist, ECMO, ECLA, Murray-score, SOFA-score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Novalung GmbH, Heilbronn, Germany, Studiensekretariat Intensivmedizin; II. Medizinische Klinik; Klinikum rechts der Isar; Munich
- Study start
- Nov 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Sep 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 compare the effect of interventional Lung Assist iLA activve to standard therapy in mechanically ventilated patients with severe acute lung impairment. Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or death) within 28 days compared to standard treatment.
Detailed description
Background:
Mechanical ventilation in patients with acute lung impairment further injures the lungs by inspiration forces and inflammatory response. Large efforts have been invested in reducing ventilator-associated lung damage by lower tidal volumes. However, benefits are limited by potential harms of permissive hypercapnia.
Therefore, extracorporeal membrane oxygenation (ECMO) and CO2-removal have been studied for more than 40 years. However, ECMO remained restricted to few specialized centres capable to provide extensive resources. Transfer of patients implicates loss of time and risks of transportation. Therefore, less invasive devices have been developed, including "pump-less "extracorporeal lung assist" (pECLA) and pump-driven ECLA (e.g. iLA activve). Despite pilot trials supporting feasibility, safety and efficient oxygenation and decarboxylation by pump-driven ECLA, there are no randomized controlled trials (RCT) proving a benefit regarding long-term endpoints.
Objectives:
Therefore, the aim of this multicentre RCT is to compare the outcome of 150 patients with early (after ≤96h of mechanical ventilation) acute lung impairment treated by pump-driven ECLA with iLA activve with a blood flow of at least 1L/min vs. 150 controls with standard intensive care including low tidal volume ventilation.
Main inclusion and exclusion criteria:
While most trials on ECMO and (p)ECLA included patients in a rescue scenario with severe and persisting ARDS, earlier inclusion also implicates modified inclusion criteria: A cumulative Murray score of ≥6 points without radiological points is the most important inclusion criterion. At least four points must result from pO2/FiO2 (mandatory pO2/FiO2<300mmHg) and PEEP criteria of the Murray score. In order to provide sufficient time for conservative attempts to optimize ventilation, inclusion criteria can be fulfilled for a maximum of 48h before inclusion as long as the patient can be included within a maximum of 96h of mechanical ventilation.
Primary efficacy endpoint:
Incidence of an increase in SOFA-Score ≥3 points or death within 28 days.
Statistical analyses:
Generalized linear mixed model (logit link function) will be used to compare the primary efficacy endpoint, the proportion of patients with an increase in SOFA of ≥3 points or death within 28d, between the two groups. In this analysis the random factor variable study centre and anticoagulation therapy will be considered as adjustment variables. The test of group effect estimated by the multivariable mixed logistic model will be conducted at a two-sided 0.05 level of significance.
The primary efficacy analysis will be based on the intention-to-treat population. Missing values of SOFA score will be replaced by last-value carry forward approach.
Survival status of lost to follow-up patients will be replaced conservatively: missing survival status will be replaced by attribute "death" for patients in the verum arm and replaced by attribute "alive" for patients in the standard treatment arm.
A supportive complete case and per-protocol analysis will be conducted for purpose of sensitivity analysis of the primary endpoint. Further sensitivity analyses will be provided to evaluate robustness of results in regard to unexpected circumstances (e.g. impact of 'cross-over' patients who are not treated as randomized but are required to be analyzed as randomized (ITT-principle)). Secondary endpoints will be analyzed in an exploratory manner.
Chi-Square test or Fisher-exact test will be used to compare categorical data. For comparisons of continuous data between groups non-parametric tests (Kruskal-Wallis test, Mann-Whitney-U test) will be performed. 95% confidence intervals will be calculated for relevant measurements. SAS software (version 4.9 or future follow-up version).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: iLA activve treatmentIntervention: iLA activve treatment. iLA activve treatment also requires anticoagulation with un-fractionized heparin and pre-defined PTT-goals (45s-60s depending on blood flow). |
| Control group | Active comparator | Procedure: Control groupControls: standard care according to good clinical practice and recent guidelines; no extracorporeal lung assist. For ethical reasons patients of the control group can be treated with iLA activve after fulfilling the primary endpoint criterium of an increase in SOFA ≥3 points. These cross-over patients will be analyzed as controls ("intention to treat"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Potentially reversible lung failure AND
- Cumulative Murray score ≥6 points without radiological points for a maximum of 48h AND
- Cumulative Murray score ≥4 points for pO2/FiO and PEEP AND
- Cumulative Murray score ≥1 point for pO2/FiO
- Mechanical ventilation for ≤96h AND
Key exclusion criteria (5 listed)
- SOFA-Score >20
- Life expectancy <24h
- mechanical ventilation >96h
- Heparin-induced thrombopenia
- Intracranial bleeding
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 |
|---|---|---|
| iLA activve treatmentAlso: ECMO, Extra-corporeal lung assistiLA activve is aimed at efficient extracorporeal membrane oxygenation with an initial blood flow of ≥2L/min. The length of therapy is at the discretion of the treating physician. Treating physicians are recommended to use a pre-specified algorithm to optimize the extracorporeal lung assist (choice of cannulas and oxygenator, titration of blood flow and sweep gas flow). Primary/mandatory goals are pO2≥65mmHg, P_peak ≤30cm H2O, TV ≤6ml/kg PBW and pH ≥7.25. Secondary suggested goals are setting the PEEP level within the limits suggested by the ARDSnet low and high PEEP strategy, 35mmHg ≤ pCO2 ≤45mmHg, Delta-pressure (= P_peak - PEEP) ≤15 cm H2O and P_peak ≤25 cm H2O. iLA activve treatment also requires anticoagulation with un-fractionized heparin (PTT-goal 45s-60s depending on blood flow). | Procedure or surgery | Intervention group |
| Control groupThe controls will be treated according to the recent guideline of the German Sepsis Society and the German Interdisciplinary Association of Intensive Care and Emergency Medicine and good clinical practice including lung-protective ventilation with low tidal volume (LTV), moderate hypercapnia, PEEP according to ARDSnet, adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) and treatment of the underlying disease as applied in the experimental group. There will be no sham treatment of iLA activve.in the controls. All adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) are also available for the intervention group. | Procedure or surgery | Control group |
Primary outcome
Incidence of an increase in SOFA-Score ≥3 points or death within 28 days
Time frame: 28 days
12 secondary outcomes
Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone
Time frame: 6 months
Mortality
Time frame: 28 days, 60 days, ICU-stay
Ventilator free days
Time frame: 28 days, ICU stay
Single organ failures as assessed by SOFA
Time frame: 28 days, ICU stay
Prediction of outcome (Primary endpoint: Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)
Time frame: 28 days
Safety analysis assessed by documentation of complications and side effects potentially related to iLA activve and/or conventional therapy including complications associated to cannulation and extracorporeal circuit,
Time frame: 6 months
Meta-analysis
Time frame: 6 months
Resource use and economic outcomes
Time frame: 6 months
Early vs. late intervention
Time frame: 6 months
Prediction of outcome (Death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone)
Time frame: 6 months
Association of the fluid balance to the primary endpoint (Incidence of an increase in SOFA-Score ≥3 points or death within 28 days)
Time frame: 28 days
Association of the fluid balance to the secondary endpoint "death or severe disability after 6 months defined as confinement to bed and inability to wash or dress alone)"
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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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.
Wolfgang Huber, MD principal investigator
II. Medizinische Klinik; Klinikum rechts der Isar; Ismaningerstrasse 22; D-81675 München; Germany
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLA activve treatment in people with Acute Respiratory Distress Syndrome, run by Technical University of Munich at 8 sites in 4 countries.
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 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Hungary, United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Huber, MD (++49-89-4140-5214, Wolfgang.Huber@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of an increase in SOFA-Score ≥3 points or death within 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2015; AzTrials last refreshed its copy on 6 Nov 2026.