Covid19, SARS-CoV Infection, ARDS, ARDS, Human
Conditions
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
Interventions
DRUGInstilled 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.
OTHERPlacebo 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Extravascular Lung Water Index | 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | Baseline to ICU discharge up to 30 days | Outcome is reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm. |
| Number of Ventilator-Free Days | 30 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. |
| 30-day Survival | 30 days | Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment. |
| Creatinine Concentration | 4 days | Outcome is reported as the number of participants in each arm with abnormally high plasma creatinine concentration (greater 1.21 milligrams per deciliter). |
| Glomerular Filtration Rate | 4 days | 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. |
| New York Heart Association (NYHA) Functional Classification | 30 days | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTimothy P Rich, MD
University of Minnesota
STUDY_CHAIRDavid Ingbar, MD
University of Minnesota
Outcome results
None listed