Topical Lung T3 Therapy for COVID-19 ARDS

Overseen By Melisa Bailey

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Disqualifiers: Pregnancy

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: Up to 30 days

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Topical Lung T3 Therapy safe for humans?

In a study with healthy rats, a reformulated version of T3 given directly into the lungs showed no harmful effects, paving the way for human trials. Additionally, T3 therapy has been found safe in short-term use for cardiac patients, with no negative effects on heart rate or mortality. ^{1 2 3 4 5}

How does the drug Instilled T3 differ from other treatments for COVID-19 ARDS?

Instilled T3 is unique because it involves directly delivering a thyroid hormone (T3) into the lungs to enhance fluid clearance and improve lung function, which is different from other treatments that may not target alveolar fluid clearance directly. This method is novel as it uses a reformulated version of T3 to avoid tracheal injury, and it is specifically designed to address the lung complications associated with ARDS, including those caused by COVID-19. ^{1 3 6 7 8}

What data supports the effectiveness of this treatment for COVID-19 ARDS?

Research shows that thyroid hormone T3 can improve lung function by enhancing fluid clearance in the lungs, which is crucial for recovery in conditions like ARDS. In animal studies, T3 has been shown to be safe when properly formulated and administered directly into the lungs, paving the way for clinical trials in humans. ^{1 3 5 9 10}

Who Is on the Research Team?

Timothy P Rich, MD

Principal Investigator

University of Minnesota

David Ingbar, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for patients with severe COVID-19-related lung damage (ARDS) who meet specific criteria, including recent onset of symptoms, certain x-ray findings, and need for mechanical breathing support. They must have a confirmed SARS-CoV-2 infection within the last 14 days. Pregnant individuals cannot participate.

Inclusion Criteria

You have been diagnosed with acute respiratory distress syndrome (ARDS) based on specific criteria, including chest X-ray showing certain patterns, needing mechanical ventilation or oxygen support, and having low oxygen levels in the blood.

You tested positive for COVID-19 within the past two weeks.

Exclusion Criteria

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive direct topical lung instilled T3 therapy or placebo while on mechanical ventilation

Up to 30 days

Daily monitoring during ICU stay

Follow-up

Participants are monitored for survival, end-organ dysfunction, quality of life, and return to work

12 months

Follow-up at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Instilled T3
• Placebo Therapy

Trial Overview The study is testing whether directly applying T3 to the lungs of patients on ventilators can improve outcomes compared to a placebo. Patients are randomly assigned to receive either the actual T3 treatment or a placebo without any active medication.

How Is the Trial Designed?

Group I: T3 Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive the experimental intervention.

Group II: Placebo Therapy Placebo Group 1 Intervention

Participants in this arm will receive placebo therapy.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A reformulated version of the thyroid hormone T3, when administered intratracheally in a safe dose, showed no significant adverse effects in a preclinical study with healthy rats, paving the way for future clinical trials.

This study supports the initiation of a phase I/II clinical trial to evaluate the safety and tolerability of T3 in patients with acute respiratory distress syndrome (ARDS), including those affected by COVID-19, highlighting its potential as a treatment for pulmonary edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preclinical Safety Study of Thyroid Hormone Instilled into the Lungs of Healthy Rats-an Investigational Therapy for ARDS. Flory, CM., Norris, BJ., Larson, NA., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A Preclinical Safety Study of Thyroid Hormone Instilled into the Lungs of Healthy Rats-an Investigational Therapy for ARDS. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Pulmonary biophysical effects of triiodothyronine augmentation during sepsis-induced hypothyroidism. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A longitudinal assessment of thyroid hormone concentrations in preterm infants younger than 30 weeks' gestation during the first 2 weeks of life and their relationship to outcome. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Postnatal triiodothyronine replacement and respiratory distress syndrome of the preterm infant. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Low triiodothyronine (T3) state: a predictor of outcome in respiratory failure? Results of a clinical pilot study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Triiodothyronine Treatment in Cardiac Surgery or Cardiovascular Diseases: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Action of topical thyroid hormone analogues on glucocorticoid-induced skin atrophy in mice. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

A thyroid hormone analogue, triiodothyroacetic acid, corrects corticosteroid-downregulated collagen synthesis. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Glucocorticoid-thyroid hormone interactions in fetal rat lung. [2019]

10. Sweden pubmed.ncbi.nlm.nih.gov

Dose-response effects of tri-iodothyroacetic acid (Triac) and other thyroid hormone analogues on glucocorticoid-induced skin atrophy in the haired mouse. [2019]