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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

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

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.