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Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725110
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection ARDS ARDS, Human Drug: Instilled T3 Other: Placebo Therapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kelly McCormick, MBA, MSL 6126243315 kmmccorm@umn.edu
Contact: Melisa Bailey 6126242627 baile807@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55117
Contact: Kelly M McCormick       kmmccorm@umn.ediu   
Principal Investigator: David Ingbar, MD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Timothy P Rich, MD University of Minnesota
Study Chair: David Ingbar, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04725110    
Other Study ID Numbers: ARDS NIH Grant
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders