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

A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a 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 (INTEGRIS-ARDS)

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

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Distress Syndrome; SARS-CoV-2
• Intervention / Treatment: Drug: Placebo; Drug: PLN-74809

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Valleywise Health Medical Center
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Orlando, Florida, United States, 32803
      • Advent Health
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
  • New Jersey
    • Summit, New Jersey, United States, 07960
      • Atlantic Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLN-74809 Dose Level1; Dose Level 1 of PLN-74809	Drug: Placebo; Placebo; Drug: PLN-74809; PLN-74809
Experimental: PLN-74809 Dose Level 2; Dose Level 2 of PLN-74809	Drug: Placebo; Placebo; Drug: PLN-74809; PLN-74809
Experimental: PLN74809 Dose Level 3; Dose Level 3 of PLN-74809	Drug: Placebo; Placebo; Drug: PLN-74809; PLN-74809

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0	Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.	Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit

Collaborators and Investigators

• Sponsor: Pliant Therapeutics, Inc.
• Investigators: Study Director: Pliant Therapeutics, Pliant Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PLN-74809-ARDS-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No