Acute Respiratory Distress Syndrome (ARDS)Phase 3NCT07317050
Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment
A Phase 3 study testing Aprotinin (inhaled) in people with Acute Respiratory Distress Syndrome (ARDS), run by Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion at 1 site in Spain.
Trial summary
This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (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?
- Aprotinin (inhaled)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jun 2026to 1 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- Diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition (ARDS Definition Task Force 2012):
- Acute onset of respiratory failure within 1 week of a known clinical insult or new/worsening respiratory symptoms.
- Respiratory failure not fully explained by cardiac failure or fluid overload; objective evaluation of cardiac failure or fluid overload is required if ARDS risk factors are absent.
- Radiographic abnormalities on chest X-ray or CT scan: bilateral opacities not fully explained by effusions, nodules, masses, or lobar/segmental collapse.
- Hypoxemia:
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- Moderate ARDS: PaO₂/FiO₂ >100 mmHg and ≤200 mmHg with Positive End-Expiratory Pressure (PEEP) ≥5 cmH₂O.
- Severe ARDS: PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cmH₂O.
- Radiographic and hypoxemia criteria must occur within the same 24-hour period. ARDS onset is defined as the time when the last of these two criteria is met.
- First dose of study drug planned within 48 hours of moderate or severe ARDS diagnosis.
- Intubated and receiving mechanical ventilation.
- Age ≥18 years.
- Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at study start. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use an effective contraceptive method from consent until 30 days after study drug administration.
Who cannot join
- Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- Pregnant or lactating women, or positive/indeterminate pregnancy test (serum or urine).
- Simultaneous participation in another pharmacotherapy protocol.
- Life expectancy <24 hours.
- Clinical condition in which, in the investigator's opinion, ventilator withdrawal is extremely unlikely (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial lung disease).
- Severe chronic obstructive pulmonary disease requiring long-term home oxygen or mechanical ventilation (noninvasive or tracheostomy), except Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) used solely for sleep-related respiratory disorders.
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- Congestive heart failure defined as New York Heart Association (NYHA) class IV.
- Acute left ventricular failure.
- Severe hepatic impairment (Child-Pugh class C).
- Prior interferon therapy.
- Known hypersensitivity to natural or recombinant IFN beta or any excipients.
- Receiving renal dialysisfor chronic renal failure.
- Receiving extracorporeal membrane oxygenation (ECMO), high-frequency oscillatory ventilation, or any form of extracorporeal pulmonary support.
- Mechanical ventilation, (invasive or noninvasive, excluding CPAP alone), for more than 48 hours before ARDS diagnosis. Noninvasive ventilation must be applied continuously for at least 12 hours/day during those 48 hours.
- Burns covering ≥15% total body surface.
- Women with positive pregnancy test at screening (serum) or study start (urine); lactating subjects; subjects planning pregnancy within 1 month after the study (including male partners).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francisco Javier Redondo Calvo, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Francisco Javier Redondo Calvo, MD, Ph.D, +34 926 27 80 00 ext. Ext: 21160, fjredondo@sescam.jccm.es
About this study
Official title: Aprotinin Treatment of Acute Respiratory Distress Syndrome: a Multicenter, Double-blind, Placebo-controlled, Phase III Trial
This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). A total of 156 critically ill patients admitted to intensive care units will be randomized to receive either inhaled aprotinin or placebo in addition to standard supportive care. The primary objective is to determine whether aprotinin improves clinical outcomes based on a composite endpoint of ventilator-free days at 28 days.
Read the detailed description
This study is a nation-wide, multicentre, double-blind, placebo-controlled, Phase III randomized clinical trial designed to investigate the efficacy and safety of inhaled aprotinin in adult patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). ARDS is a heterogeneous acute inflammatory lung syndrome characterized by diffuse alveolar damage, increased vascular permeability, alveolar and interstitial edema, and severe hypoxemic respiratory failure. Despite advances in supportive care, no specific pharmacological therapy has demonstrated proven benefit.
Aprotinin is a broad-spectrum serine protease inhibitor that targets the kallikrein-kinin system and attenuates systemic inflammatory responses, including reductions in pro-inflammatory cytokines and matrix metalloproteinases (MMPs). Experimental and clinical data suggest that MMP overexpression contributes to tissue damage, coagulation abnormalities, and impaired lung repair, representing a potential therapeutic target in ARDS. Inhaled aprotinin has been used clinically in patients with respiratory conditions, including COVID-19 and chronic pulmonary disease, with no reported adverse events via this route of administration.
In this trial, 156 ICU patients with moderate or severe ARDS will be enrolled and randomized in a 1:1 ratio to receive either inhaled aprotinin or placebo, both administered alongside standard supportive care. The aprotinina dosing regimen will be four inhaled doses of 500 KIU every six hours (total 2,000 KIU/day), selected to achieve effective local pulmonary concentrations while minimizing systemic exposure. The primary endpoint is a composite of ventilator-free days at 28 days among survivors. Secondary outcomes include ICU and hospital mortality, duration of mechanical ventilation, and other clinically relevant respiratory and functional endpoints. Detailed study procedures, dosing, and administration are described in the study protocol.
All study procedures will be conducted under a double-blind design. Patients will be prospectively followed for clinical outcomes during their ICU and hospital stay according to prespecified assessment timepoints. A Data Monitoring Committee (DMC) composed of independent clinical experts will periodically review safety and efficacy data, ensuring the protection of participants and the scientific validity of the study. The estimated study duration is four years, from September 2025 to September 2029.
- Being tested
- Aprotinin (inhaled), Placebo (Sodium Chloride)
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Inhaled Aprotinin, Phase III Clinical Trial, Ventilator-free days, Pulmonary Function, Inflammatory Biomarkers
- 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.
Aprotinin (inhaled)Drug
Inhaled aprotinin, diluted in 0.9% sodium chloride, is administrated via nebulization through an endotracheal or tracheostomy tube. The dose is 500 UI every 6 hours (totaling 2,000 UI/day) for six consecutive days. Each administration consists of a nebulized inhalation lasting no less than six minutes, with four inhalations delivered per day. Nebulization is performed using Aerogen® Solo vibrating mesh nebulizers to maintain a closed ventilatory circuit. The device produces aerosol particles with a median diameter of 2-10 µm; 30-50% of these aggregates reach diameters of 50-100 µm. Administration follows pharmacy blinding procedures. All patients receive standard supportive care according to local practice.
Placebo (Sodium Chloride)Drug
Placebo (sodium chloride) is administered by inhalation via endotracheal or tracheostomy tube using the Aerogen® Solo vibrating mesh nebulizer, four times daily for six consecutive days. It is delivered following the same dosing schedule, device specifications, and administration procedures as the active treatment. Administration follows pharmacy blinding procedures to maintain double-blind conditions. All patients receive standard supportive care according to local practice.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Aprotinin Group | Experimental | Patients in this Experimental Group will receive inhaled aprotinin as an adjunctive therapy to standard supportive care for ARDS. Treatment is administered four times daily for 6 consecutive days. All patients continue to receive standard supportive care according to local practice. Receives: Drug: Aprotinin (inhaled) |
| Inhaled Placebo Group | Placebo comparator | Patients in this Control Group will receive inhaled placebo (sodium chloride) as an adjunctive therapy to standard supportive care for ARDS. Administration schedule matches the experimental group, four times daily for 6 consecutive days. All patients continue to receive standard supportive care according to local practice. Receives: Drug: Placebo (Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Free Days (VFD) in patients with moderate or severe ARDS
Number of days a patient is free from invasive mechanical ventilation (DLVI) within 28 days after first dose. A patient is considered ventilator-free after two consecutive calendar days of unassisted breathing. This outcome will be used to assess the efficacy of inhaled aprotinin compared with placebo.
Measured: From first dose up to Day 28
Secondary outcomes (9)
Number of participants with at least one treatment-emergent adverse event
Incidence, severity, and relationship to treatment of adverse events (AEs), coded according to MedDRA (Medical Dictionary for Regulatory Activities), in treated participants. This outcome evaluates the safety profile of aprotinin compared with placebo.
Measured: From first dose up to Day 180
Proportion of patients who die from any cause within 28, 90, or 180 days after receiving first dose of study treatment.
All-Cause Mortality.
Measured: At Day 28, Day 90, and Day 180
Number of days free from ICU or hospital
Total number of days a patient remains outside the intensive care unit (ICU) and outside the hospital within 28 days after receiving first dose of study treatment.
Measured: From first dose up to Day 28
Number of days on renal or vasoactive support within 28 days after first dose
Total number of days a patient requires renal replacement therapy or vasoactive support within 28 days after receiving first dose of study treatment.
Measured: From first dose up to Day 28
Sequential Organ Failure Assessment (SOFA) score
Sequential Organ Failure Assessment (SOFA) score evaluated daily from Day 1 to Day 14, and on Days 21 and 28.
Measured: From Day 1 up to Day 28
PaO₂/FiO₂ ratio during mechanical ventilation
Daily evaluation of the arterial oxygen partial pressure to inspired oxygen fraction (PaO₂/FiO₂) ratio during mechanical ventilation as an indicator of pulmonary function improvement in patients receiving study treatment.
Measured: From Day 1 up to Day 28
Plasma inflammatory biomarkers
Measurement of plasma levels of selected pro- and anti-inflammatory cytokines (GM-CSF, IFN-α, IFN-γ, IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A, TNF-α), chemokines (IP-10/CXCL10, MCP-1/CCL2, MIP-1α/CCL3, MIP-1β/CCL4), and cell adhesion/response markers (ICAM-1, CD62E/E-selectin, CD62P/P-selectin) in plasma on Day 1 and Day 5 in all participants receiving study treatment. Evaluates the effect of aprotinina on systemic inflammation.
Measured: Day 1 and Day 5
Pulmonary biomarkers in bronchial and plasma samples
Determination of granular proteins, bradykinin, and kallikreins in bronchial brush and plasma samples on Day 1 and Day 5 as exploratory markers of pulmonary response and treatment effect of aprotinin.
Measured: Day 1 and Day 5
Plasma aprotinin levels
Measurement of plasma aprotinin concentrations on Day 1 and Day 5 in all participants receiving study treatment.
Measured: Day 1 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start18 Jun 2026
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (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 Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, multicentre, double-blind, randomized, parallel-group clinical trial evaluating the efficacy and safety of inhaled aprotinin versus placebo in adult patients with moderate or severe ARDS.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317050
- Sponsor's protocol ID
- ICI24/00011
- Other IDs
- 2025-520826-39-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprotinin Treatment of Acute Respiratory Distress Syndrome: a Multicenter, Double-blind, Placebo-controlled, Phase III Trial
- ClinicalTrials.gov ID
- NCT07317050
- Acronym / sponsor ID
- ICI24/00011
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Inhaled Aprotinin, Phase III Clinical Trial, Ventilator-free days, Pulmonary Function, Inflammatory Biomarkers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la IntegracionUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 5 Jan 2026 (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.
This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). A total of 156 critically ill patients admitted to intensive care units will be randomized to receive either inhaled aprotinin or placebo in addition to standard supportive care. The primary objective is to determine whether aprotinin improves clinical outcomes based on a composite endpoint of ventilator-free days at 28 days.
Detailed description
This study is a nation-wide, multicentre, double-blind, placebo-controlled, Phase III randomized clinical trial designed to investigate the efficacy and safety of inhaled aprotinin in adult patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). ARDS is a heterogeneous acute inflammatory lung syndrome characterized by diffuse alveolar damage, increased vascular permeability, alveolar and interstitial edema, and severe hypoxemic respiratory failure. Despite advances in supportive care, no specific pharmacological therapy has demonstrated proven benefit.
Aprotinin is a broad-spectrum serine protease inhibitor that targets the kallikrein-kinin system and attenuates systemic inflammatory responses, including reductions in pro-inflammatory cytokines and matrix metalloproteinases (MMPs). Experimental and clinical data suggest that MMP overexpression contributes to tissue damage, coagulation abnormalities, and impaired lung repair, representing a potential therapeutic target in ARDS. Inhaled aprotinin has been used clinically in patients with respiratory conditions, including COVID-19 and chronic pulmonary disease, with no reported adverse events via this route of administration.
In this trial, 156 ICU patients with moderate or severe ARDS will be enrolled and randomized in a 1:1 ratio to receive either inhaled aprotinin or placebo, both administered alongside standard supportive care. The aprotinina dosing regimen will be four inhaled doses of 500 KIU every six hours (total 2,000 KIU/day), selected to achieve effective local pulmonary concentrations while minimizing systemic exposure. The primary endpoint is a composite of ventilator-free days at 28 days among survivors. Secondary outcomes include ICU and hospital mortality, duration of mechanical ventilation, and other clinically relevant respiratory and functional endpoints. Detailed study procedures, dosing, and administration are described in the study protocol.
All study procedures will be conducted under a double-blind design. Patients will be prospectively followed for clinical outcomes during their ICU and hospital stay according to prespecified assessment timepoints. A Data Monitoring Committee (DMC) composed of independent clinical experts will periodically review safety and efficacy data, ensuring the protection of participants and the scientific validity of the study. The estimated study duration is four years, from September 2025 to September 2029.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase III, multicentre, double-blind, randomized, parallel-group clinical trial evaluating the efficacy and safety of inhaled aprotinin versus placebo in adult patients with moderate or severe ARDS.
| Arm | Type | Receives |
|---|---|---|
| Inhaled Aprotinin Group | Experimental | Drug: Aprotinin (inhaled)Patients in this Experimental Group will receive inhaled aprotinin as an adjunctive therapy to standard supportive care for ARDS. Treatment is administered four times daily for 6 consecutive days. All patients continue to receive standard supportive care according to local practice. |
| Inhaled Placebo Group | Placebo comparator | Drug: Placebo (Sodium Chloride)Patients in this Control Group will receive inhaled placebo (sodium chloride) as an adjunctive therapy to standard supportive care for ARDS. Administration schedule matches the experimental group, four times daily for 6 consecutive days. All patients continue to receive standard supportive care according to local practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- Diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition (ARDS Definition Task Force 2012):
- Radiographic and hypoxemia criteria must occur within the same 24-hour period. ARDS onset is defined as the time when the last of these two criteria is met.
- First dose of study drug planned within 48 hours of moderate or severe ARDS diagnosis.
- Intubated and receiving mechanical ventilation.
Key exclusion criteria (16 listed)
- Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- Pregnant or lactating women, or positive/indeterminate pregnancy test (serum or urine).
- Simultaneous participation in another pharmacotherapy protocol.
- Life expectancy <24 hours.
- Clinical condition in which, in the investigator's opinion, ventilator withdrawal is extremely unlikely (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial lung disease).
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 |
|---|---|---|
| Aprotinin (inhaled)Inhaled aprotinin, diluted in 0.9% sodium chloride, is administrated via nebulization through an endotracheal or tracheostomy tube. The dose is 500 UI every 6 hours (totaling 2,000 UI/day) for six consecutive days. Each administration consists of a nebulized inhalation lasting no less than six minutes, with four inhalations delivered per day. Nebulization is performed using Aerogen® Solo vibrating mesh nebulizers to maintain a closed ventilatory circuit. The device produces aerosol particles with a median diameter of 2-10 µm; 30-50% of these aggregates reach diameters of 50-100 µm. Administration follows pharmacy blinding procedures. All patients receive standard supportive care according to local practice. | Drug | Inhaled Aprotinin Group |
| Placebo (Sodium Chloride)Placebo (sodium chloride) is administered by inhalation via endotracheal or tracheostomy tube using the Aerogen® Solo vibrating mesh nebulizer, four times daily for six consecutive days. It is delivered following the same dosing schedule, device specifications, and administration procedures as the active treatment. Administration follows pharmacy blinding procedures to maintain double-blind conditions. All patients receive standard supportive care according to local practice. | Drug | Inhaled Placebo Group |
Primary outcome
Ventilator-Free Days (VFD) in patients with moderate or severe ARDS
Time frame: From first dose up to Day 28
Number of days a patient is free from invasive mechanical ventilation (DLVI) within 28 days after first dose. A patient is considered ventilator-free after two consecutive calendar days of unassisted breathing. This outcome will be used to assess the efficacy of inhaled aprotinin compared with placebo.
9 secondary outcomes
Number of participants with at least one treatment-emergent adverse event
Time frame: From first dose up to Day 180
Proportion of patients who die from any cause within 28, 90, or 180 days after receiving first dose of study treatment.
Time frame: At Day 28, Day 90, and Day 180
Number of days free from ICU or hospital
Time frame: From first dose up to Day 28
Number of days on renal or vasoactive support within 28 days after first dose
Time frame: From first dose up to Day 28
Sequential Organ Failure Assessment (SOFA) score
Time frame: From Day 1 up to Day 28
PaO₂/FiO₂ ratio during mechanical ventilation
Time frame: From Day 1 up to Day 28
Plasma inflammatory biomarkers
Time frame: Day 1 and Day 5
Pulmonary biomarkers in bronchial and plasma samples
Time frame: Day 1 and Day 5
Plasma aprotinin levels
Time frame: Day 1 and Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Francisco Javier Redondo Calvo, MD, PhD contact
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 Aprotinin (inhaled) in people with Acute Respiratory Distress Syndrome (ARDS), run by Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion at 1 site in Spain.
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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. 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 Spain. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier Redondo Calvo, MD, PhD (+34 926 27 80 00 ext. Ext: 21160, fjredondo@sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days (VFD) in patients with moderate or severe ARDS (time frame: From first dose up to Day 28). 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 Jul 2026.