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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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change Extravascular Lung Water Index
Secondary study objectives
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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,423 Previous Clinical Trials
1,619,535 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
8 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
~167 spots leftby Oct 2029
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