Status:
NOT_YET_RECRUITING
Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome
Lead Sponsor:
University of Minnesota
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
Exclusion
- Pregnancy
- Inclusion Criteria:
- 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
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2031
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04725110
Start Date
January 15 2026
End Date
October 15 2031
Last Update
February 17 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55117