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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04725110
• Other study ID #: ARDS NIH Grant
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: April 2029

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: Kelly McCormick, MBA, MSL
• Phone: 6126243315
• Email: kmmccorm[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 2029
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• ARDS, Human
• COVID-19
• Covid19
• Respiratory Distress Syndrome
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

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.

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 days
Secondary	30-day Survival	Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.	30 days
Secondary	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
Secondary	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
Secondary	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