Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome
Purpose
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.
Conditions
- Covid19
- SARS-CoV Infection
- ARDS
- ARDS, Human
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental T3 Intervention |
Participants in this arm will receive the experimental intervention. |
|
Placebo Comparator Placebo Therapy |
Participants in this arm will receive placebo therapy. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04725110
- Status
- Not yet recruiting
- Sponsor
- University of Minnesota
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