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

Purpose

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

Conditions

  • Acute Respiratory Distress Syndrome
  • SARS-CoV-2

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

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
PLN-74809 Dose Level1 		Dose Level 1 of PLN-74809
  • Drug: PLN-74809
    PLN-74809
  • Drug: Placebo
    Placebo
Experimental
PLN-74809 Dose Level 2 		Dose Level 2 of PLN-74809
  • Drug: PLN-74809
    PLN-74809
  • Drug: Placebo
    Placebo
Experimental
PLN74809 Dose Level 3 		Dose Level 3 of PLN-74809
  • Drug: PLN-74809
    PLN-74809
  • Drug: Placebo
    Placebo

Recruiting Locations

More Details

NCT ID
NCT04565249
Status
Terminated
Sponsor
Pliant Therapeutics, Inc.

Detailed Description

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