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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT04725110
Status
Not yet recruiting
Sponsor
University of Minnesota

Study Contact

Kelly McCormick, MBA, MSL
6126243315
kmmccorm@umn.edu

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.