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

University of Minnesota (UMN)

Status and phase: Begins enrollment in 8 months; Phase 2

Conditions: SARS-CoV Infection; Covid19; ARDS, Human; ARDS

Treatments: Drug: Instilled T3; Other: Placebo Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04725110

PACCS-2020-23242

Details and patient eligibility

About

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

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

T3 Intervention

Experimental group

Description:

Participants in this arm will receive the experimental intervention.

Treatment:

Drug: Instilled T3

Placebo Therapy

Placebo Comparator group

Description:

Participants in this arm will receive placebo therapy.

Treatment:

Other: Placebo Therapy