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

Phase II Trial of Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 ARDS - A Multi-Site, Randomized, Double-blinded, Placebo-Controlled Clinical Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Covid19; ARDS; SARS-CoV Infection; ARDS, Human
• Intervention / Treatment: Drug: Instilled T3; Other: Placebo Therapy

Detailed Description

Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55117
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Exclusion Criteria:

• Pregnancy

Inclusion Criteria:

• Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,

• Diagnosis of ARDS by the Berlin Criteria (2012):

  1. Onset: < 7 days
  2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates
  3. Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O
  4. Pulmonary Edema: Not fully explained by cardiogenic etiology
  5. Hypoxia: PaO2/FIO2 Ratio < 300, or O2Sat/FIO2 Ratio < 315

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T3 Intervention; Participants in this arm will receive the experimental intervention.	Drug: Instilled T3; The first dose of T3 (50 micrograms in 10 mls volume BID) will be instilled by an investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. T3 doses will be given in 50 mcg doses twice daily for 4 days.
Placebo Comparator: Placebo Therapy; Participants in this arm will receive placebo therapy.	Other: Placebo Therapy; A placebo therapy will be instilled into the lungs by the investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. Doses will be given twice daily for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Extravascular Lung Water Index	EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 1 hour post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU Stay	Outcome is reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.	Baseline to ICU discharge up to 30 days
Number of Ventilator-Free Days	Outcome is reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.	30 days
30-day Survival	Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.	30 days
Creatinine Concentration	Outcome is reported as the number of participants in each arm with abnormally high plasma creatinine concentration (greater 1.21 milligrams per deciliter).	4 days
Glomerular Filtration Rate	Outcome is reported as the number of participants in each arm with impaired kidney function, defined as a glomerular filtration rate (GFR) less than 60 mL/min/1.73 m^2.	4 days
New York Heart Association (NYHA) Functional Classification	Outcome is reported as the number of participants in each arm who fall into each of 4 categories: 1 (no limitation in normal physical activity), 2 (mild symptoms only in normal activity), 3 (marked symptoms during daily activities, asymptomatic only at rest), and 4 (severe limitations, symptoms even at rest).	30 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Timothy P Rich, MD, University of Minnesota; Study Chair: David Ingbar, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): October 15, 2031

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiratory Distress Syndrome; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: PACCS-2020-23242

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No