Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.
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
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.
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.
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
University of Minnesota
Minneapolis, Minnesota, United States