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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
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.
University of Minnesota
Minneapolis, Minnesota, United States
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.
Time frame: 1 hour
Length of ICU Stay
Outcome is reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Time frame: Baseline to ICU discharge up to 30 days
Number of Ventilator-Free Days
Outcome is reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Time frame: 30 days
30-day Survival
Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.
Time frame: 30 days
Creatinine Concentration
Outcome is reported as the number of participants in each arm with abnormally high plasma creatinine concentration (greater 1.21 milligrams per deciliter).
Time frame: 4 days
Glomerular Filtration Rate
Outcome is reported as the number of participants in each arm with impaired kidney function, defined as a glomerular filtration rate (GFR) less than 60 mL/min/1.73 m\^2.
Time frame: 4 days
New York Heart Association (NYHA) Functional Classification
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Outcome is reported as the number of participants in each arm who fall into each of 4 categories: 1 (no limitation in normal physical activity), 2 (mild symptoms only in normal activity), 3 (marked symptoms during daily activities, asymptomatic only at rest), and 4 (severe limitations, symptoms even at rest).
Time frame: 30 days