ARDS, HumanPhase 2ARDS+T3NCT04115514

Treatment of ARDS With Instilled T3

A Phase 2 study testing Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation. and Non-intervention in people with ARDS, Human and Lung, Wet, run by University of Minnesota at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

It is hypothesized that instillation of Liothyronine Sodium (T3) into the airspace will be safe, well tolerated, and will increase alveolar fluid clearance and decrease inflammation in patients with ARDS, reflected in improved oxygenation index (OI) and oxygenation saturation index (OSI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ARDS, Human, Lung, Wet, Thyroid
What is being tested?: Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation. and Non-intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 2 sitesUnited States
Study dates: 30 Mar 2020to 31 Oct 2026
Phase: Phase 2
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

Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit.
Adults (≥18 years of age).
Male or female (non-pregnant).
Clinical diagnosis of ARDS (all are required):
Onset: <= 7 days.
Chest x-ray: Bilateral Patchy Opacities, Infiltrates.

Show all 11Show fewer

Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O.
Pulmonary Edema: Not fully explained by cardiogenic etiology.
Hypoxia: PaO2/FIO2 Ratio <300, or O2Sat/FIO2 Ratio <315.
On mechanical ventilatory support.
Capable of giving informed consent directly or from the subject's legally authorized representative (LAR) as determined by the site Principal Investigator and/or Sub- Investigators.

Who cannot join

Patients with any of the following conditions will be excluded from this trial:
Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub- Investigators.
Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub- Investigators or hospice status.
Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
Prior history of cardiovascular disease defined as:
Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg),

Show all 14Show fewer

Sustained ventricular arrhythmia in the past 3 months (duration >30 seconds)
Coronary artery disease (documented >=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization.
Cardiac-related angina pectoris (>=2 episodes in the past 3 months)
Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of >1mm in contiguous leads).
Peripheral vascular disease (documented >=70% occlusion untreated in any peripheral vessel), as per the 2018 ACC/AHA/SCAI/SIR/SVM Guidelines for Appropriate Use Criteria for Peripheral Artery Intervention.
Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
Currently pregnant or breastfeeding.
Known allergy to study drug.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

M Health Fairview Southdale Hospital
Edina, Minnesota, 55435
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: PHASE II RANDOMIZED, INTERVENTION VERSUS NON- INTERVENTION, MULTI- CENTER STUDY OF THE EFFECTS OF THYROID HORMONE (T3) ON SAFETY/TOLERABILITY AND OXYGENATION IN SUBJECTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)

Read the detailed description

T3 Therapy in ARDS- Phase 2 Randomized, Unblinded, Intervention versus Non- Intervention Trial. Enrollment 68 participants (50 treatment + 18 control). Purpose- To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on Oxygenation in ARDS patients. Study Drug- Liothyronine Sodium (T3), 50 mcg will be instilled twice daily via a catheter through the ETT into the airway in a total volume of 10 mL (T3+0.9% sodium chloride), over 5 days (10 total doses), or until extubation, whichever comes first.

Conditions: ARDS, Human, Lung, Wet, Thyroid, Pulmonary Edema, Lung Inflammation
Being tested: Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation., Non-intervention
Medical subject headings: Respiratory Distress Syndrome, Pulmonary Edema, Thyroid Diseases, Pneumonia

What participants receive

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

Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.Drug
Study Drug Administration:
- Dose/Volume- Liothyronine Sodium 50 mcg / 10 mL
- Frequency/Duration: Twice daily over 5 days (10 total doses), or until extubation, whichever comes first.
- Method: Instilled via a catheter through the ETT directly into the airway.
Non-interventionOther
Standard of Care (SOC)

Study groups in NCT04115514
Study group	Role	What they receive
Treatment Arm	Experimental	Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation. Receives: Drug: Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
Control arm	Other	Standard of Care Receives: Other: Non-intervention

What is being measured

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

Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: baseline
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 6 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 12 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 24 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 48 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 72 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 96 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP):
OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Measured: 120 hours post-dose

Secondary outcomes (18)

Pulmonary events
Progressive hemoptysis: bright, red blood in streaks, mixed or clots within sputum on suctioning of greater than 30 mL accumulation anytime following the initial and subsequent intratracheal dosing administrations.
Measured: baseline and 120 hours post-dose
Cardiovascular event 1
New sustained ventricular arrhythmia (>30 secs)
Measured: baseline to 120hours post-dose
Cardiovascular event 2
New sustained accelerated junctional arrhythmia (rate >80 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg).
Measured: baseline to 120hours post-dose
Cardiovascular event 3
New sustained atrial fibrillation with rapid ventricular response (ventricular rate >160 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg).
Measured: baseline to 120hours post-dose
Cardiovascular event 4
Cardiac arrest (pulseless electrical activity, or asystole).
Measured: baseline to 120hours post-dose
Cardiovascular event 5
Hypertensive crisis (systolic pressure of 180 mmHg (or higher), or diastolic pressure of 120 mmHg (or higher) or change in MAP > 20 mmHg with three consecutive measurements over 30 minutes).
Measured: baseline to 120hours post-dose
SOC pulmonary vasodilator
yes or no
Measured: baseline and 5 days
SOC pressor(s) dose(s)
Measured: baseline and 5 days
SOC diurectic(s) dose(s)
Measured: baseline and 5 days
Ventilator Free Days
Measured: baseline and 5 days
ICU Free Days
Measured: baseline and 5 days
Oxygen Free Days
Measured: baseline and 5 days
All-Cause Mortality
Measured: baseline and 5 days
Tracheostomy placement requirement
Measured: baseline and 5 days
Supplemental oxygen on discharge
yes or no
Measured: baseline and 5 days
Discharge disposition
home, inpatient rehabilitation, long-term acute care hospital (LTACH)
Measured: baseline and 5 days
TSH, Total T3, Free T3, Free T4
Measured: baseline and 156-hrs post-dose
Free T3, Free T4
Measured: baseline and 5 days

Timeline

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

30 Mar 202031 Oct 2026

First posted4 Oct 2019
Study start30 Mar 2020
Primary completion31 Oct 2026
Study completion31 Oct 2026

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 ARDS, HumanStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, unblinded, intervention versus non-intervention trial. 68 \[50 treatment + 18 controls\]
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04115514
Sponsor's protocol ID: PACS-2020-23242
Acronym: ARDS+T3
Status last verified: Nov 2026
First submitted: 12 Mar 2019
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Flory CM, Norris BJ, Larson NA, Coicou LG, Koniar BL, Mysz MA, Rich TP, Ingbar DH, Schumacher RJ. A Preclinical Safety Study of Thyroid Hormone Instilled into the Lungs of Healthy Rats-an Investigational Therapy for ARDS. J Pharmacol Exp Ther. 2021 Jan;376(1):74-83. doi: 10.1124/jpet.120.000060. Epub 2020 Oct 30.
PubMed 33127750

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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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PHASE II RANDOMIZED, INTERVENTION VERSUS NON- INTERVENTION, MULTI- CENTER STUDY OF THE EFFECTS OF THYROID HORMONE (T3) ON SAFETY/TOLERABILITY AND OXYGENATION IN SUBJECTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
ClinicalTrials.gov ID: NCT04115514
Acronym / sponsor ID: ARDS+T3 / PACS-2020-23242
Conditions: ARDS, Human, Lung, Wet, Thyroid, Pulmonary Edema, Lung Inflammation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 30 Mar 2020 (actual)
Primary completion: 31 Oct 2026 (actual)
Study completion: 31 Oct 2026 (actual)
First posted: 4 Oct 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized, unblinded, intervention versus non-intervention trial. 68 [50 treatment + 18 controls]

Arm	Type	Receives
Treatment Arm	Experimental	Drug: Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
Control arm	Other	Other: Non-interventionStandard of Care

Who may qualify

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

Key inclusion criteria (11 listed)

Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit.
Adults (≥18 years of age).
Male or female (non-pregnant).
Clinical diagnosis of ARDS (all are required):
On mechanical ventilatory support.

Key exclusion criteria (14 listed)

Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub- Investigators.
Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub- Investigators or hospice status.
Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
Prior history of cardiovascular disease defined as:
Currently pregnant or breastfeeding.

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
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.Study Drug Administration: * Dose/Volume- Liothyronine Sodium 50 mcg / 10 mL * Frequency/Duration: Twice daily over 5 days (10 total doses), or until extubation, whichever comes first. * Method: Instilled via a catheter through the ETT directly into the airway.	Drug	Treatment Arm
Non-interventionStandard of Care (SOC)	Other	Control arm

Primary outcome

Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: baseline
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 6 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 12 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 24 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 48 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 72 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 96 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Time frame: 120 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).

18 secondary outcomes

Pulmonary events
Time frame: baseline and 120 hours post-dose
Cardiovascular event 1
Time frame: baseline to 120hours post-dose
Cardiovascular event 2
Time frame: baseline to 120hours post-dose
Cardiovascular event 3
Time frame: baseline to 120hours post-dose
Cardiovascular event 4
Time frame: baseline to 120hours post-dose
Cardiovascular event 5
Time frame: baseline to 120hours post-dose
SOC pulmonary vasodilator
Time frame: baseline and 5 days
SOC pressor(s) dose(s)
Time frame: baseline and 5 days
SOC diurectic(s) dose(s)
Time frame: baseline and 5 days
Ventilator Free Days
Time frame: baseline and 5 days
ICU Free Days
Time frame: baseline and 5 days
Oxygen Free Days
Time frame: baseline and 5 days
All-Cause Mortality
Time frame: baseline and 5 days
Tracheostomy placement requirement
Time frame: baseline and 5 days
Supplemental oxygen on discharge
Time frame: baseline and 5 days
Discharge disposition
Time frame: baseline and 5 days
TSH, Total T3, Free T3, Free T4
Time frame: baseline and 156-hrs post-dose
Free T3, Free T4
Time frame: baseline and 5 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 3 Nov 2026.
Derived from this study: PubMed 33127750Flory CM, Norris BJ, Larson NA, Coicou LG, Koniar BL, Mysz MA, Rich TP, Ingbar DH, Schumacher RJ. A Preclinical Safety Study of Thyroid Hormone Instilled into the Lungs of Healthy Rats-an Investigational Therapy for ARDS. J Pharmacol Exp Ther. 2021 Jan;376(1):74-83. doi: 10.1124/jpet.120.000060. Epub 2020 Oct 30.
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. This study is not recruiting at the moment.

Timothy P Rich, MD study director

University of Minnesota

David H Ingbar, MD study chair

University of Minnesota

Ronald A Reikoff, MD principal investigator

University of Minnesota

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

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 14 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 3 Nov 2026. 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). (time frame: baseline). 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 NCT04115514, 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 3 Nov 2026.