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

NCT ID: NCT04725110

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2031-10-15

Brief Summary

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

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

T3 Intervention

Participants in this arm will receive the experimental intervention.

Group Type: EXPERIMENTAL

Instilled T3

Intervention Type: 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.

Placebo Therapy

Participants in this arm will receive placebo therapy.

Group Type: PLACEBO_COMPARATOR

Placebo Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

Exclusion Criteria

• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy P Rich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

David Ingbar, MD

Role: STUDY_CHAIR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Kelly McCormick, MBA, MSL

Role: CONTACT

kmmccorm@umn.edu

6126243315

Melisa Bailey

Role: CONTACT

baile807@umn.edu

6126242627

Facility Contacts

Kelly M McCormick

Role: primary

kmmccorm@umn.ediu

Other Identifiers

PACCS-2020-23242

Identifier Type: -

Identifier Source: org_study_id