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

NCT04725110 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: PACCS-2020-23242
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; SARS-CoV Infection; ARDS; ARDS, Human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Length of ICU Stay

  Baseline to ICU discharge up to 30 days

• Number of Ventilator-Free Days

  30 days

• 30-day Survival

  30 days

• Creatinine Concentration

  4 days

• Glomerular Filtration Rate

  4 days

Study Arms (2)

T3 Intervention

EXPERIMENTAL

Participants in this arm will receive the experimental intervention.

Drug: Instilled T3

Placebo Therapy

PLACEBO COMPARATOR

Participants in this arm will receive placebo therapy.

Other: Placebo Therapy

Interventions

Instilled T3 DRUG

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.

T3 Intervention

Placebo Therapy OTHER

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.

Placebo Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnancy
• Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
• Diagnosis of ARDS by the Berlin Criteria (2012):
• Onset: \< 7 days
• Chest x-ray: Bilateral Patchy Opacities, Infiltrates
• Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O
• Pulmonary Edema: Not fully explained by cardiogenic etiology
• Hypoxia: PaO2/FIO2 Ratio \< 300, or O2Sat/FIO2 Ratio \< 315

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55117, United States

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Timothy P Rich, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• David Ingbar, MD

  University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: January 15, 2026
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): October 15, 2031
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)