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Duplicate record to NCT04115514
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3 Intervention | Experimental | Participants in this arm will receive the experimental intervention. |
|
| Placebo Therapy | Placebo Comparator | Participants in this arm will receive placebo therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instilled T3 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to ICU discharge up to 30 days |
| Number of Ventilator-Free Days |
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Exclusion Criteria:
Inclusion Criteria:
Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
Diagnosis of ARDS by the Berlin Criteria (2012):
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| Name | Affiliation | Role |
|---|---|---|
| Timothy P Rich, MD | University of Minnesota | Principal Investigator |
| David Ingbar, MD | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55117 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo Therapy | Other | 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. |
|
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 days |
| 30-day Survival | Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment. | 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). | 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. | 4 days |
| New York Heart Association (NYHA) Functional Classification | 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). | 30 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |