Treatment of ARDS With Instilled T3

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.

Inclusion criteria

Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit.

• Adults (≥18 years of age).
• Male or female (non-pregnant).
• Clinical diagnosis of ARDS (all are required):

• Onset: <= 7 days.
• Chest x-ray: Bilateral Patchy Opacities, Infiltrates.
• Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O.
• Pulmonary Edema: Not fully explained by cardiogenic etiology.
• Hypoxia: PaO2/FIO2 Ratio <300, or O2Sat/FIO2 Ratio <315.
• On mechanical ventilatory support.
• Capable of giving informed consent directly or from the subject's legally authorized representative (LAR) as determined by the site Principal Investigator and/or Sub- Investigators.

Exclusion criteria

Patients with any of the following conditions will be excluded from this trial:

• Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub- Investigators.
• Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub- Investigators or hospice status.
• Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
• Prior history of cardiovascular disease defined as:

• Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg),
• Sustained ventricular arrhythmia in the past 3 months (duration >30 seconds)
• Coronary artery disease (documented >=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization.
• Cardiac-related angina pectoris (>=2 episodes in the past 3 months)
• Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of >1mm in contiguous leads).
• Peripheral vascular disease (documented >=70% occlusion untreated in any peripheral vessel), as per the 2018 ACC/AHA/SCAI/SIR/SVM Guidelines for Appropriate Use Criteria for Peripheral Artery Intervention.
• Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
• Currently pregnant or breastfeeding.
• Known allergy to study drug.