Acute Respiratory Distress Syndrome (ARDS)Phase 4NCT07711964
Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome
A Phase 4 study testing No steroids (Arm A), Corticosteroids, low dose for 10 days and Corticosteroids, low dose for 7 days in people with Acute Respiratory Distress Syndrome (ARDS), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in… 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?
- No steroids (Arm A), Corticosteroids, low dose for 10 days and Corticosteroids, low dose for 7 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2025to 30 Jun 2030
- Phase
- Phase 4
- 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
- ARDS (as defined by the Berlin definition) with an FiO₂ of 0.5 or higher
- On invasive mechanical ventilation
- Duration of intubation less than three days
Who cannot join
- Age less than 18 years
- Required to receive steroids or considered ineligible for steroids by the primary care team
- Receiving systemic steroid therapy
- Uncontrolled gastrointestinal bleeding
- Uncontrolled infeciotn
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Research Ethics Committee of NTUH, 886233667190, ntuhrec@ntuh.gov.tw
About this study
Official title: Corticosteroids for Acute Respiratory Distress Syndrome: A Proof-of-Concept Trial Exploring Biological Heterogeneity and Treatment Response
The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in favor of corticosteroid use in early ARDS. However, the optimal dose and duration of corticosteroid therapy remain unclear. Low-dose, short-course regimens have been evaluated in clinical trials for severe pneumonia and COVID-19. However, no head-to-head comparisons have been conducted to evaluate the efficacy of prolonged versus short courses of corticosteroid therapy in ARDS.
To address this gap, the investigators designed a 3×2 factorial trial to assess corticosteroid therapy for ARDS, aiming to evaluate the effects of different doses (no steroid, medium-low dose, and medium dose) and durations (prolonged vs. short) on clinical outcomes. In addition, the investigators will measure changes in inflammatory biomarkers for post hoc analysis to explore whether these biomarkers could guide the selection of steroid regimens.
- Being tested
- No steroids (Arm A), Corticosteroids, low dose for 10 days, Corticosteroids, low dose for 7 days, Corticosteroids, medium dose for 10 days, Corticosteroids, medium dose for 7 days
- Keywords
- Acute Respiratory Distress Syndrome, ARDS, Corticosteroid
- 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.
No steroids (Arm A)Other
Standard care for ARDS without corticosteroids.
Corticosteroids, low dose for 10 daysDrug
Dexamethasone: low dose for 10 days
Corticosteroids, low dose for 7 daysDrug
Dexamethasone: low dose for 7 days
Corticosteroids, medium dose for 10 daysDrug
Dexamethasone: medium dose for 10 days
Corticosteroids, medium dose for 7 daysDrug
Dexamethasone: medium dose for 7 days
No steroids (Arm B)Other
Standard care for ARDS without corticosteroids.
| Study group | Role | What they receive |
|---|---|---|
| (Arm A) No steroids | Other | Standard care without corticosteroid therapy. Receives: Other: No steroids (Arm A) |
| (Arm B) No steroids | Other | Standard care without corticosteroid therapy. Receives: Other: No steroids (Arm B) |
| (Arm C) Steroids with low dose for 10 days | Experimental | Dexamethasone 0.1 mg/kg from day 1 to day 5 and 0.05 mg/kg from day 6 to day 10. Receives: Drug: Corticosteroids, low dose for 10 days |
| (Arm D) Steroids with low dose for 7 days | Experimental | Dexamethasone 0.1 mg/kg from day 1 to day 4 and 0.05 mg/kg from day 5 to day 7. Receives: Drug: Corticosteroids, low dose for 7 days |
| (Arm E) Steroids with medium dose for 10 days | Experimental | Dexamethasone 0.2 mg/kg from day 1 to day 5 and 0.1 mg/kg from day 6 to day 10. Receives: Drug: Corticosteroids, medium dose for 10 days |
| (Arm F) Steroids with medium dose for 7 days | Experimental | Dexamethasone 0.2 mg/kg from day 1 to day 4 and 0.1 mg/kg from day 5 to day 7. Receives: Drug: Corticosteroids, medium dose for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day ventilator-free survival
Proportion of ventilator-free survival at day 28 between intervention arms (arms C, D, E, and F) and control arms (arms A and B)
Measured: 28 days
Secondary outcomes (8)
28-day ventilator-free survival between low and medium dose groups
Proportion of ventilator-free survival at day 28 between low dose (arm C and D) and medium dose (arm E and F) of corticosteroids.
Measured: 28 days
28-day ventilator-free survival between long and short treatment duration groups
Proportion of ventilator-free survival at day 28 between long-course treatment (arms C and E) and short-course treatment (arms D and F)
Measured: 28 days
ICU mortality
Proportion of death in the ICU
Measured: From ICU admission to discharge, an average of 21 days
60-day mortality
Proportion of death in 60 days
Measured: 60 days
Oxygenation improvement on day 7
Proportion of patients with PaO2/FiO2 ratio > 200 mmHg on day 7
Measured: 7 days
Proportion of nosocomial infection
Proportion of nosocomial infection during hospitalization (up to 30 days)
Measured: 30 days
Proportion of lymphocytopenia
Proportion of lymphocytopenia in 10 days
Measured: 10 days
Hyperglycemia
Peak blood glucose level during initial 10 days
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jun 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Jun 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.
- More trials run by National Taiwan University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711964
- Sponsor's protocol ID
- 202503094MIND
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2025
- Last updated
- 17 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids for Acute Respiratory Distress Syndrome: A Proof-of-Concept Trial Exploring Biological Heterogeneity and Treatment Response
- ClinicalTrials.gov ID
- NCT07711964
- Acronym / sponsor ID
- 202503094MIND
- Keywords
- Acute Respiratory Distress Syndrome, ARDS, Corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 17 Jul 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 early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in favor of corticosteroid use in early ARDS. However, the optimal dose and duration of corticosteroid therapy remain unclear. Low-dose, short-course regimens have been evaluated in clinical trials for severe pneumonia and COVID-19. However, no head-to-head comparisons have been conducted to evaluate the efficacy of prolonged versus short courses of corticosteroid therapy in ARDS.
To address this gap, the investigators designed a 3×2 factorial trial to assess corticosteroid therapy for ARDS, aiming to evaluate the effects of different doses (no steroid, medium-low dose, and medium dose) and durations (prolonged vs. short) on clinical outcomes. In addition, the investigators will measure changes in inflammatory biomarkers for post hoc analysis to explore whether these biomarkers could guide the selection of steroid regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| (Arm A) No steroids | Other | Other: No steroids (Arm A)Standard care without corticosteroid therapy. |
| (Arm B) No steroids | Other | Other: No steroids (Arm B)Standard care without corticosteroid therapy. |
| (Arm C) Steroids with low dose for 10 days | Experimental | Drug: Corticosteroids, low dose for 10 daysDexamethasone 0.1 mg/kg from day 1 to day 5 and 0.05 mg/kg from day 6 to day 10. |
| (Arm D) Steroids with low dose for 7 days | Experimental | Drug: Corticosteroids, low dose for 7 daysDexamethasone 0.1 mg/kg from day 1 to day 4 and 0.05 mg/kg from day 5 to day 7. |
| (Arm E) Steroids with medium dose for 10 days | Experimental | Drug: Corticosteroids, medium dose for 10 daysDexamethasone 0.2 mg/kg from day 1 to day 5 and 0.1 mg/kg from day 6 to day 10. |
| (Arm F) Steroids with medium dose for 7 days | Experimental | Drug: Corticosteroids, medium dose for 7 daysDexamethasone 0.2 mg/kg from day 1 to day 4 and 0.1 mg/kg from day 5 to day 7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ARDS (as defined by the Berlin definition) with an FiO₂ of 0.5 or higher
- On invasive mechanical ventilation
- Duration of intubation less than three days
Key exclusion criteria (5 listed)
- Age less than 18 years
- Required to receive steroids or considered ineligible for steroids by the primary care team
- Receiving systemic steroid therapy
- Uncontrolled gastrointestinal bleeding
- Uncontrolled infeciotn
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 |
|---|---|---|
| No steroids (Arm A)Standard care for ARDS without corticosteroids. | Other | (Arm A) No steroids |
| Corticosteroids, low dose for 10 daysDexamethasone: low dose for 10 days | Drug | (Arm C) Steroids with low dose for 10 days |
| Corticosteroids, low dose for 7 daysDexamethasone: low dose for 7 days | Drug | (Arm D) Steroids with low dose for 7 days |
| Corticosteroids, medium dose for 10 daysDexamethasone: medium dose for 10 days | Drug | (Arm E) Steroids with medium dose for 10 days |
| Corticosteroids, medium dose for 7 daysDexamethasone: medium dose for 7 days | Drug | (Arm F) Steroids with medium dose for 7 days |
| No steroids (Arm B)Standard care for ARDS without corticosteroids. | Other | (Arm B) No steroids |
Primary outcome
28-day ventilator-free survival
Time frame: 28 days
Proportion of ventilator-free survival at day 28 between intervention arms (arms C, D, E, and F) and control arms (arms A and B)
8 secondary outcomes
28-day ventilator-free survival between low and medium dose groups
Time frame: 28 days
28-day ventilator-free survival between long and short treatment duration groups
Time frame: 28 days
ICU mortality
Time frame: From ICU admission to discharge, an average of 21 days
60-day mortality
Time frame: 60 days
Oxygenation improvement on day 7
Time frame: 7 days
Proportion of nosocomial infection
Time frame: 30 days
Proportion of lymphocytopenia
Time frame: 10 days
Hyperglycemia
Time frame: 10 days
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 17 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing No steroids (Arm A), Corticosteroids, low dose for 10 days and Corticosteroids, low dose for 7 days in people with Acute Respiratory Distress Syndrome (ARDS), run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 17 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Sheng-Yuan Ruan, MD, PhD (886223123456, syruan@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day ventilator-free survival (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 17 Jul 2026.