Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome
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|ClinicalTrials.gov Identifier: NCT04725110|
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : September 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS-CoV Infection ARDS ARDS, Human||Drug: Instilled T3 Other: Placebo Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Trial of Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 ARDS - A Multi-Site, Randomized, Double-blinded, Placebo-Controlled Clinical Trial|
|Actual Study Start Date :||October 29, 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2024|
Experimental: T3 Intervention
Participants in this arm will receive the experimental intervention.
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.
Placebo Comparator: Placebo Therapy
Participants in this arm will receive placebo therapy.
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.
- Change Extravascular Lung Water Index [ Time Frame: 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.
- Length of ICU Stay [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days ]Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.
- Creatinine Concentration [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725110
|Contact: Kelly McCormick, MBA, MSLemail@example.com|
|Contact: Melisa Baileyfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55117|
|Contact: Kelly M McCormick email@example.com|
|Principal Investigator: David Ingbar, MD|
|Principal Investigator:||Timothy P Rich, MD||University of Minnesota|
|Study Chair:||David Ingbar, MD||University of Minnesota|