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

Phase 2

Terminated

• Conditions: Acute Respiratory Distress Syndrome; SARS-CoV-2
• Interventions: Drug: PLN-74809; Drug: Placebo

• Registration Number: NCT04565249
• Lead Sponsor: Pliant Therapeutics, Inc.

Brief Summary

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

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 Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Study Start: 2020-10-22
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-02
• Results First Submitted: 2022-09-22
• Results First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Results First Posted: 2022-11-17
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLN-74809 Dose Level1	Placebo	Dose Level 1 of PLN-74809
PLN-74809 Dose Level1	PLN-74809	Dose Level 1 of PLN-74809
PLN-74809 Dose Level 2	PLN-74809	Dose Level 2 of PLN-74809
PLN-74809 Dose Level 2	Placebo	Dose Level 2 of PLN-74809
PLN74809 Dose Level 3	PLN-74809	Dose Level 3 of PLN-74809
PLN74809 Dose Level 3	Placebo	Dose Level 3 of PLN-74809

Primary Outcome Measures

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

Trial Locations

Locations (6)

Advent Health; 🇺🇸 Orlando, Florida, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Augusta University Medical Center; 🇺🇸 Augusta, Georgia, United States

Atlantic Health System; 🇺🇸 Summit, New Jersey, United States

Valleywise Health Medical Center; 🇺🇸 Phoenix, Arizona, United States