Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson 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
Investigator: Kelly M McCormick
kmmccorm@umn.ediu
Investigator: David Ingbar, MD
Kelly McCormick, MBA, MSL
6126243315
kmmccorm@umn.edu
Melisa Bailey
6126242627
baile807@umn.edu