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

Primary Purpose

Covid19, SARS-CoV Infection, ARDS

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Instilled T3
Placebo Therapy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

T3 Intervention

Placebo Therapy

Arm Description

Participants in this arm will receive the experimental intervention.

Participants in this arm will receive placebo therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
30-day Survival
Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.
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).
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.
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).

Full Information

First Posted
January 21, 2021
Last Updated
July 26, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04725110
Brief Title
Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 29, 2023 (Anticipated)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV Infection, ARDS, ARDS, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T3 Intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive the experimental intervention.
Arm Title
Placebo Therapy
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive placebo therapy.
Intervention Type
Drug
Intervention Name(s)
Instilled T3
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Therapy
Intervention Description
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 Measure Information:
Title
Change Extravascular Lung Water Index
Description
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
Secondary Outcome Measure Information:
Title
Length of ICU Stay
Description
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
Title
Number of Ventilator-Free Days
Description
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
Title
30-day Survival
Description
Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.
Time Frame
30 days
Title
Creatinine Concentration
Description
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
Title
Glomerular Filtration Rate
Description
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
Title
New York Heart Association (NYHA) Functional Classification
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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): Onset: < 7 days Chest x-ray: Bilateral Patchy Opacities, Infiltrates Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O Pulmonary Edema: Not fully explained by cardiogenic etiology Hypoxia: PaO2/FIO2 Ratio < 300, or O2Sat/FIO2 Ratio < 315
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly McCormick, MBA, MSL
Phone
6126243315
Email
kmmccorm@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melisa Bailey
Phone
6126242627
Email
baile807@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy P Rich, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Ingbar, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly M McCormick
Email
kmmccorm@umn.ediu
First Name & Middle Initial & Last Name & Degree
David Ingbar, MD

12. IPD Sharing Statement

Learn more about this trial

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

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