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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for severe COVID-19-related lung problems. It uses T3 therapy, a topical treatment delivered directly to the lungs, to aid patients on ventilators. The study compares this treatment to a placebo to determine if T3 can improve lung health. Individuals with a confirmed COVID-19 diagnosis in the past two weeks who are currently on a ventilator due to severe lung issues may qualify. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that T3 therapy has been tested for safety in both animals and humans. In one study, healthy rats received a form of T3 directly into their lungs without any harm. This finding enabled researchers to begin testing T3 in humans.

Previous studies have also examined using T3 to treat ARDS, a serious lung condition, and found it to be safe and well-tolerated. These studies helped secure approval to test T3 in people with conditions like COVID-19-related ARDS.

While these studies suggest T3 is safe, it remains under investigation, and more research is needed to fully understand its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-ARDS?

Unlike the standard treatments for COVID-19 ARDS, which often involve mechanical ventilation and supportive care, the investigational treatment of instilled T3 offers a novel approach. Researchers are excited about T3 because it's a form of thyroid hormone that may help improve lung function directly when applied topically, potentially reducing inflammation and enhancing recovery. This unique delivery method targets the lungs specifically, which could make it more effective than systemic therapies that affect the whole body. By directly addressing lung issues, T3 might offer quicker and more targeted relief for patients suffering from severe respiratory distress.

What evidence suggests that instilled T3 might be an effective treatment for COVID-ARDS?

Research has shown that T3, a thyroid hormone, might improve oxygen levels in people with Acute Respiratory Distress Syndrome (ARDS), including those with COVID-19. In earlier studies, T3 reduced signs of lung distress when administered directly into the lungs of patients on ventilators. Studies in healthy rats demonstrated that this method did not cause harm, suggesting it is safe to test in humans. This trial will compare the effects of T3, administered to participants in the T3 Intervention arm, with a placebo therapy given to participants in the Placebo Therapy arm. The main goal is to determine if T3 can improve oxygen levels and support better breathing in humans. ^{1 3 4 5 6}

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022356524257384

A Preclinical Safety Study of Thyroid Hormone Instilled into ... This study enabled Food and Drug Administration approval of a phase I/II clinical trial of T3 instillation in patients with ARDS, including coronavirus disease ...

2. withpower.com withpower.com/trial/phase-3-covid-19-2-2022-ce8ad

Topical Lung T3 Therapy for COVID-19 ARDS · Info for Participants 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04115514

NCT04115514 | Treatment of ARDS With Instilled T3 To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 ...

4. ctv.veeva.com ctv.veeva.com/study/direct-topical-lung-t3-treatment-to-improve-outcome-sequelae-of-covid-19-acute-respiratory-distres

Direct Topical Lung T3 Treatment to Improve Outcome ... Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33127750/

A Preclinical Safety Study of Thyroid Hormone Instilled into ... This preclinical safety study has paved the way for a phase I/II study to determine the safety and tolerability of a T3 formulation delivered into the lungs of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04725110?tab=table

Direct Topical Lung T3 Treatment to Improve Outcome & ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...