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Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

NCT07711964 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-17

No results posted yet for this study

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 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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Interventions

OTHER

No steroids (Arm A)

Standard care for ARDS without corticosteroids.

DRUG

Corticosteroids, low dose for 10 days

Dexamethasone: low dose for 10 days

DRUG

Corticosteroids, low dose for 7 days

Dexamethasone: low dose for 7 days

DRUG

Corticosteroids, medium dose for 10 days

Dexamethasone: medium dose for 10 days

DRUG

Corticosteroids, medium dose for 7 days

Dexamethasone: medium dose for 7 days

OTHER

No steroids (Arm B)

Standard care for ARDS without corticosteroids.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2030-04-30
Completion
2030-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711964 on ClinicalTrials.gov