Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: Other: No steroids (Arm A); Other: No steroids (Arm B); Drug: Corticosteroids, low dose for 10 days; Drug: Corticosteroids, low dose for 7 days; Drug: Corticosteroids, medium dose for 10 days; Drug: Corticosteroids, medium dose for 7 days

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sheng-Yuan Ruan, MD, PhD; Phone Number: 886223123456; Email: syruan@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Research Ethics Committee of NTUH; Phone Number: 886233667190; Email: ntuhrec@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: (Arm A) No steroids; Standard care without corticosteroid therapy.	Other: No steroids (Arm A); Standard care for ARDS without corticosteroids.
Other: (Arm B) No steroids; Standard care without corticosteroid therapy.	Other: No steroids (Arm B); Standard care for ARDS without corticosteroids.
Experimental: (Arm C) Steroids with low dose for 10 days; Dexamethasone 0.1 mg/kg from day 1 to day 5 and 0.05 mg/kg from day 6 to day 10.	Drug: Corticosteroids, low dose for 10 days; Dexamethasone: low dose for 10 days
Experimental: (Arm D) Steroids with low dose for 7 days; Dexamethasone 0.1 mg/kg from day 1 to day 4 and 0.05 mg/kg from day 5 to day 7.	Drug: Corticosteroids, low dose for 7 days; Dexamethasone: low dose for 7 days
Experimental: (Arm E) Steroids with medium dose for 10 days; Dexamethasone 0.2 mg/kg from day 1 to day 5 and 0.1 mg/kg from day 6 to day 10.	Drug: Corticosteroids, medium dose for 10 days; Dexamethasone: medium dose for 10 days
Experimental: (Arm F) Steroids with medium dose for 7 days; Dexamethasone 0.2 mg/kg from day 1 to day 4 and 0.1 mg/kg from day 5 to day 7.	Drug: Corticosteroids, medium dose for 7 days; Dexamethasone: medium dose for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	28 days
ICU mortality	Proportion of death in the ICU	From ICU admission to discharge, an average of 21 days
60-day mortality	Proportion of death in 60 days	60 days
Oxygenation improvement on day 7	Proportion of patients with PaO2/FiO2 ratio > 200 mmHg on day 7	7 days
Proportion of nosocomial infection	Proportion of nosocomial infection during hospitalization (up to 30 days)	30 days
Proportion of lymphocytopenia	Proportion of lymphocytopenia in 10 days	10 days
Hyperglycemia	Peak blood glucose level during initial 10 days	10 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: June 29, 2025
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: ARDS; Corticosteroid; Acute Respiratory Distress Syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: 202503094MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No