Acute Respiratory Distress SyndromePhase 2NCT05401812
Glucocorticoid Therapy for Acute Respiratory Distress Syndrome
A Phase 2 study testing Intravenous glucocorticoid therapy in people with Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital.
Trial summary
Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Intravenous glucocorticoid therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Apr 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe ARDS with a P/F ratio < 200 mmHg
- On invasive mechanical ventilation
- The onset of ARDS < 72 hours
Who cannot join
- Age <20 years
- Receiving systemic glucocorticoid therapy
- Uncontrolled gastrointestinal bleeding
- Terminal cancer
- Post-operation or with large wound
- Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy
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- Anticipating to receive chemotherapy and immunotherapy in 3 months
- Uncontrolled fungal infection
- Post solid organ or bone marrow transplant
- Severe influenza without anti-viral therapy
About this study
Official title: A Factorial Trial of Glucocorticoid Therapy in Acute Respiratory Distress Syndrome: Optimizing Dosing Regimen and Developing Biomarker-guided Treatment
Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Despite the advance in the critical care technology, the mortality of ARDS remains high in the last decades. Glucocorticoids have profound anti-inflammatory actions through the pleiotropic effects of the glucocorticoid receptor, which are considering a promising pharmacological therapy to mitigate the inflammatory lung injury and subsequent fibrosis in ARDS. Previous clinical trials have repeatedly tested the efficacy of glucocorticoid therapy in ARDS; however, the data about hard outcomes, such as mortality, are inconsistent between these studies. Investigators designed a 3x2 factorial trial of glucocorticoid therapy in ARDS to test the effects of glucocorticoid dosages (dose 0, dose 0.5 mg/kg, and dose 1 mg/kg of methylprednisolone equivalence) and durations (prolonged and short duration) on the treatment efficacy. In addition, investigators will measure the change of inflammatory biomarkers for post-hoc analysis to explore whether biomarkers could be used to guide patient selection and steroid tapering.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Intravenous glucocorticoid therapy
- Keywords
- Acute Respiratory Distress Syndrome, Corticosteroid, Glucocorticoid
- 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.
Intravenous glucocorticoid therapyDrug
Betamethasone, dexamethasone, or methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care without glucocorticoid therapy. |
| Low dose and long treatment duration | Experimental | Methylprednisolone equivalent dose 0.5 mg/kg/day for 5 days, followed by 0.25 mg/kg/day for 5 days. Receives: Drug: Intravenous glucocorticoid therapy |
| Low dose and short treatment duration | Experimental | Methylprednisolone equivalent dose 0.5 mg/kg/day for 4 days,, followed by 0.25 mg/kg/day for 3 days. Receives: Drug: Intravenous glucocorticoid therapy |
| Moderate dose and long treatment duration | Experimental | Methylprednisolone equivalent dose 1 mg/kg/day for 5 days, followed by 0.5 mg/kg/day for 5 days. Receives: Drug: Intravenous glucocorticoid therapy |
| Moderate dose and short treatment duration | Experimental | Methylprednisolone equivalent dose 1 mg/kg/day for 4 days, followed by 0.5 mg/kg/day for 3 days. Receives: Drug: Intravenous glucocorticoid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free survival
Ventilator-free survival between control and intervention arms
Measured: 28 days
Secondary outcomes (11)
Glucocorticoid dose and ventilator-free survival
Ventilator-free survival between low-dose and moderate-dose glucocorticoid groups
Measured: 28 days
Glucocorticoid treatment duration and ventilator-free survival
Ventilator-free survival between long treatment duration and short treatment duration groups
Measured: 28 days
ICU mortality
Between-group difference in mortality at ICU discharge
Measured: Length of ICU stay up to 28 days
Hospital mortality
Between-group difference in mortality at hospital discharge
Measured: Length of hospital stay up to 60 days
60-day mortality
Between-group difference in mortality by day 60
Measured: 60 days
Oxygenation on day 7
Proportion of patients with a P/F ratio > 200 mmHg on day 7
Measured: 7 days
Rapid oxygenation improvement
Change in P/F ratios between day 1 and day 3
Measured: 3 days
Successful liberation from mechanical ventilation
Median time to successful liberation from mechanical ventilation
Measured: Up to 60 days
Lymphocytopenia
Proportion of lymphocytopenia on day 7
Measured: 7 days
Blood glucose level
Peak blood glucose level during treatment
Measured: 10 days
Hyperglycemia
Proportion of patients with hyperglycemia during treatment
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 posted2 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Why it stopped: Difficult enrollment
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT05401812
- Sponsor's protocol ID
- 202012189MINB
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2022
- Last updated
- 18 Mar 2025
- 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Factorial Trial of Glucocorticoid Therapy in Acute Respiratory Distress Syndrome: Optimizing Dosing Regimen and Developing Biomarker-guided Treatment
- ClinicalTrials.gov ID
- NCT05401812
- Acronym / sponsor ID
- 202012189MINB
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Corticosteroid, Glucocorticoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Jun 2022 (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.
Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Despite the advance in the critical care technology, the mortality of ARDS remains high in the last decades. Glucocorticoids have profound anti-inflammatory actions through the pleiotropic effects of the glucocorticoid receptor, which are considering a promising pharmacological therapy to mitigate the inflammatory lung injury and subsequent fibrosis in ARDS. Previous clinical trials have repeatedly tested the efficacy of glucocorticoid therapy in ARDS; however, the data about hard outcomes, such as mortality, are inconsistent between these studies. Investigators designed a 3x2 factorial trial of glucocorticoid therapy in ARDS to test the effects of glucocorticoid dosages (dose 0, dose 0.5 mg/kg, and dose 1 mg/kg of methylprednisolone equivalence) and durations (prolonged and short duration) on the treatment efficacy. In addition, investigators will measure the change of inflammatory biomarkers for post-hoc analysis to explore whether biomarkers could be used to guide patient selection and steroid tapering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care without glucocorticoid therapy. |
| Low dose and long treatment duration | Experimental | Drug: Intravenous glucocorticoid therapyMethylprednisolone equivalent dose 0.5 mg/kg/day for 5 days, followed by 0.25 mg/kg/day for 5 days. |
| Low dose and short treatment duration | Experimental | Drug: Intravenous glucocorticoid therapyMethylprednisolone equivalent dose 0.5 mg/kg/day for 4 days,, followed by 0.25 mg/kg/day for 3 days. |
| Moderate dose and long treatment duration | Experimental | Drug: Intravenous glucocorticoid therapyMethylprednisolone equivalent dose 1 mg/kg/day for 5 days, followed by 0.5 mg/kg/day for 5 days. |
| Moderate dose and short treatment duration | Experimental | Drug: Intravenous glucocorticoid therapyMethylprednisolone equivalent dose 1 mg/kg/day for 4 days, followed by 0.5 mg/kg/day for 3 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe ARDS with a P/F ratio < 200 mmHg
- On invasive mechanical ventilation
- The onset of ARDS < 72 hours
Key exclusion criteria (10 listed)
- Age <20 years
- Receiving systemic glucocorticoid therapy
- Uncontrolled gastrointestinal bleeding
- Terminal cancer
- Post-operation or with large wound
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 |
|---|---|---|
| Intravenous glucocorticoid therapyBetamethasone, dexamethasone, or methylprednisolone | Drug | Low dose and long treatment duration, Low dose and short treatment duration, Moderate dose and long treatment duration, Moderate dose and short treatment duration |
Primary outcome
Ventilator-free survival
Time frame: 28 days
Ventilator-free survival between control and intervention arms
11 secondary outcomes
Glucocorticoid dose and ventilator-free survival
Time frame: 28 days
Glucocorticoid treatment duration and ventilator-free survival
Time frame: 28 days
ICU mortality
Time frame: Length of ICU stay up to 28 days
Hospital mortality
Time frame: Length of hospital stay up to 60 days
60-day mortality
Time frame: 60 days
Oxygenation on day 7
Time frame: 7 days
Rapid oxygenation improvement
Time frame: 3 days
Successful liberation from mechanical ventilation
Time frame: Up to 60 days
Lymphocytopenia
Time frame: 7 days
Blood glucose level
Time frame: 10 days
Hyperglycemia
Time frame: 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous glucocorticoid therapy in people with Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital.
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 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: withdrawn, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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 18 Mar 2025.