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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04565249
• Other study ID #: PLN-74809-ARDS-204
• Status: Terminated
• Phase: Phase 2
• Start date: October 22, 2020
• Est. completion date: August 2, 2021

Study information

• Verified date: September 2020
• Source: Pliant Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• SARS-CoV-2
• Syndrome

Intervention

Drug:
• PLN-74809
PLN-74809
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Augusta University Medical Center	Augusta	Georgia
United States	National Jewish Health	Denver	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Advent Health	Orlando	Florida
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	Atlantic Health System	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pliant Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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