Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each
cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to
placebo (3:1 ratio).
- In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809
or placebo QD
- In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809
or placebo QD
- In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809
or placebo QD
Drug: PLN-74809
PLN-74809
Drug: Placebo
Placebo
Inclusion Criteria:
- Diagnosis of ARDS (Berlin Criteria)
- Hospitalized with at least severe COVID-19 (FDA 2020)
- Receiving support for acute lung injury/respiratory distress via supplemental oxygen
- Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine
aminotransferase (ALT) concentration ≤ 150 U/L
- Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis
Exclusion Criteria:
- Greater than 72 hours since time of onset of ARDS.
- Greater than 7 days since start of mechanical ventilation.
- Currently receiving or anticipated to receive extracorporeal life support (ECLS),
extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation
- Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6
mL/kg of predicted body weight and prone positioning) and fluid management protocol
(Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local
institutional standards (HFOV).
Valleywise Health Medical Center
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
Advent Health
Orlando, Florida, United States
Augusta University Medical Center
Augusta, Georgia, United States
Atlantic Health System
Summit, New Jersey, United States
Pliant Therapeutics, Study Director
Pliant Therapeutics, Inc.