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Thyroid Hormone

Topical Lung T3 Therapy for COVID-19 ARDS

Phase 2

Waitlist Available

Led By Timothy P Rich, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing a new treatment for COVID-19 patients who are on mechanical ventilation and have ARDS. The treatment is a direct, topical T3 therapy that is instilled into the lungs.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions at the site of instillation, changes in thyroid hormone levels which could affect heart rate and metabolism, and possible interactions with other medications being used to treat COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change Extravascular Lung Water Index

Secondary outcome measures

30-day Survival

Creatinine Concentration

Glomerular Filtration Rate

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: T3 InterventionExperimental Treatment1 Intervention

Participants in this arm will receive the experimental intervention.

Group II: Placebo TherapyPlacebo Group1 Intervention

Participants in this arm will receive placebo therapy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,378 Previous Clinical Trials

1,588,259 Total Patients Enrolled

Timothy P Rich, MDPrincipal InvestigatorUniversity of Minnesota

1 Previous Clinical Trials

68 Total Patients Enrolled

David Ingbar, MDStudy ChairUniversity of Minnesota

1 Previous Clinical Trials

9 Total Patients Enrolled

Media Library

Instilled T3 (Thyroid Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT04725110 — Phase 2

Coronavirus Research Study Groups: T3 Intervention, Placebo Therapy

Coronavirus Clinical Trial 2023: Instilled T3 Highlights & Side Effects. Trial Name: NCT04725110 — Phase 2

Instilled T3 (Thyroid Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725110 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a current opportunity for people to participate in the research?

"This is an ongoing clinical trial that was originally posted on October 29th, 2019 and has since been updated September 1st, 2020."

Answered by AI

How many people are joining this research project?

"That is correct. The website clinicaltrials.gov has the latest information on this matter, which shows that the trial began 29th October 2019 and was last updated 1st September 2020. They are looking for 250 individuals total at a single location."

Answered by AI

Are there Instilled T3 long-term repercussions to patients?

"While Phase 2 trials are not as advanced as Phase 3, Instilled T3's safety rating is a 2. This means that while there is no data supporting efficacy, there have been promising results when it comes to safety."

Answered by AI

Might I be eligible to take part in this research?

"To be eligible for this study, participants should have ards and be human. The ages of the candidates should also fall between 18 and 80 years old. In total, the clinical trial is looking to recruit 250 individuals that fit these criteria."

Answered by AI

Does this research involve elderly participants?

"Individuals aged 18 to 80 may be eligible for this trial, as evidenced by the 196 similar studies conducted with a younger age group and 1102 trials involving an older demographic."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

2024. "Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725110.

All > Coronavirus > Ards