NCT04115514

Treatment of ARDS With Instilled T3

PHASE II RANDOMIZED, INTERVENTION VERSUS NON- INTERVENTION, MULTI- CENTER STUDY OF THE EFFECTS OF THYROID HORMONE (T3) ON SAFETY/TOLERABILITY AND OXYGENATION IN SUBJECTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is hypothesized that instillation of Liothyronine Sodium (T3) into the airspace will be safe, well tolerated, and will increase alveolar fluid clearance and decrease inflammation in patients with ARDS, reflected in improved oxygenation index (OI) and oxygenation saturation index (OSI).

Detailed description

T3 Therapy in ARDS- Phase 2 Randomized, Unblinded, Intervention versus Non- Intervention Trial. Enrollment 68 participants (50 treatment + 18 control). Purpose- To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on Oxygenation in ARDS patients. Study Drug- Liothyronine Sodium (T3), 50 mcg will be instilled twice daily via a catheter through the ETT into the airway in a total volume of 10 mL (T3+0.9% sodium chloride), over 5 days (10 total doses), or until extubation, whichever comes first.

Conditions

• ARDS, Human
• Lung, Wet
• Thyroid
• Pulmonary Edema
• Lung Inflammation

Interventions

Type	Name	Description
DRUG	Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.	Study Drug Administration: * Dose/Volume- Liothyronine Sodium 50 mcg / 10 mL * Frequency/Duration: Twice daily over 5 days (10 total doses), or until extubation, whichever comes first. * Method: Instilled via a catheter through the ETT directly into the airway.
OTHER	Non-intervention	Standard of Care (SOC)

Timeline

• Start date: 2020-03-30
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2019-10-04
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study