ARDS (Moderate or Severe)ENARCT-ARDSNCT07334873
Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome
A study testing Inhaled Nitric Oxide Therapy in people with ARDS (Moderate or Severe), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-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
- ARDS (Moderate or Severe)
- What is being tested?
- Inhaled Nitric Oxide Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Dec 2027
- Phase
- Interventional
- 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
- Age ≥ 18 years.
- Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.
Who cannot join
- Known allergy to iNO.
- Congenital methemoglobinemia.
- End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
- Shock (norepinephrine >0.5 μg/kg/min or equivalent for >6 hours) at treatment initiation.
- Pulmonary hypertension (PASP >45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
- Serum creatinine >2.5 mg/dL (221 μmol/L).
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- Major bleeding (e.g., intracranial, pulmonary) or platelet count <20×10⁹/L.
- Expected ICU/mechanical ventilation <24 hours.
- Pre-enrollment ECMO therapy.
- Any investigator-assessed unsuitability for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of Inhaled Nitric Oxide Therapy in Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Trial (ENARCT-ARDS)
The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are:
Does iNO therapy reduce 28-day all-cause mortality compared to standard care alone? Does iNO therapy increase the number of ventilator-free days through day 28? If there is a comparison group: Researchers will compare the group receiving iNO plus standard care with the group receiving placebo plus standard care to see if iNO improves survival and other clinical outcomes.
Read more
Participants will:
Be randomly assigned to receive either iNO or a placebo through the ventilator.
Receive all other standard treatments for ARDS as per current guidelines. Be closely monitored for 28 days to track survival, time on the ventilator, and safety.
- Conditions
- ARDS (Moderate or Severe)
- Being tested
- Inhaled Nitric Oxide Therapy
- Keywords
- Inhaled Nitric Oxide Therapy, ARDS
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric Oxide TherapyProcedure or surgery
Patients randomized to the intervention group will receive inhaled nitric oxide (iNO) delivered via the portable INOwill N200 system in addition to standard ARDS care. iNO administration will commence immediately upon enrollment, with its concentration set and titrated in accordance with established clinical practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care for ARDS+Inhaled Nitric Oxide | Experimental | Not described Receives: Procedure: Inhaled Nitric Oxide Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
The primary outcome was 28-day all-cause mortality, defined as death from any cause occurring within 28 days following randomization. All patients must be followed up through day 28, regardless of hospital discharge status.
Measured: within 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334873
- Sponsor's protocol ID
- NFEC-2025-708
- Acronym
- ENARCT-ARDS
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Inhaled Nitric Oxide Therapy in Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Trial (ENARCT-ARDS)
- ClinicalTrials.gov ID
- NCT07334873
- Acronym / sponsor ID
- ENARCT-ARDS / NFEC-2025-708
- Conditions
- ARDS (Moderate or Severe)
- Keywords
- Inhaled Nitric Oxide Therapy, ARDS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 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.
The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are:
Does iNO therapy reduce 28-day all-cause mortality compared to standard care alone? Does iNO therapy increase the number of ventilator-free days through day 28? If there is a comparison group: Researchers will compare the group receiving iNO plus standard care with the group receiving placebo plus standard care to see if iNO improves survival and other clinical outcomes.
Participants will:
Be randomly assigned to receive either iNO or a placebo through the ventilator.
Receive all other standard treatments for ARDS as per current guidelines. Be closely monitored for 28 days to track survival, time on the ventilator, and safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care for ARDS+Inhaled Nitric Oxide | Experimental | Procedure: Inhaled Nitric Oxide Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.
Key exclusion criteria (10 listed)
- Known allergy to iNO.
- Congenital methemoglobinemia.
- End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
- Shock (norepinephrine >0.5 μg/kg/min or equivalent for >6 hours) at treatment initiation.
- Pulmonary hypertension (PASP >45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Nitric Oxide TherapyPatients randomized to the intervention group will receive inhaled nitric oxide (iNO) delivered via the portable INOwill N200 system in addition to standard ARDS care. iNO administration will commence immediately upon enrollment, with its concentration set and titrated in accordance with established clinical practice guidelines. | Procedure or surgery | Standard of care for ARDS+Inhaled Nitric Oxide |
Primary outcome
28-day mortality
Time frame: within 28 days after randomization
The primary outcome was 28-day all-cause mortality, defined as death from any cause occurring within 28 days following randomization. All patients must be followed up through day 28, regardless of hospital discharge status.
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 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled Nitric Oxide Therapy in people with ARDS (Moderate or Severe), run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 2 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: opening soon, as of the sponsor's last update on 13 Jan 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 China. 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?
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?
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?
28-day mortality (time frame: within 28 days after randomization). 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 13 Jan 2026.