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

NCT04565249 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PLN-74809-ARDS-204
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

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

Conditions

Acute Respiratory Distress Syndrome; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

PLN-74809 Dose Level1

EXPERIMENTAL

Dose Level 1 of PLN-74809

Drug: PLN-74809; Drug: Placebo

PLN-74809 Dose Level 2

EXPERIMENTAL

Dose Level 2 of PLN-74809

Drug: PLN-74809; Drug: Placebo

PLN74809 Dose Level 3

EXPERIMENTAL

Dose Level 3 of PLN-74809

Drug: PLN-74809; Drug: Placebo

Interventions

PLN-74809 DRUG

PLN-74809

PLN-74809 Dose Level 2; PLN-74809 Dose Level1; PLN74809 Dose Level 3

Placebo DRUG

Placebo

PLN-74809 Dose Level 2; PLN-74809 Dose Level1; PLN74809 Dose Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pliant Therapeutics, Inc.: lead

Study Sites (6)

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Advent Health

Orlando, Florida, 32803, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Atlantic Health System

Summit, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Limitations and Caveats

The study was discontinued prior to completion of enrollment of Dose 1 due to the lack of participant availability following the introduction of COVID-19 vaccines as well as the increased and successful measures to contain the virus leading to a dramatic decrease in the number of severe and critical COVID-19 patients with ARDS. As a result, the study did not reach the target number of participants needed to achieve target power and statistically reliable results.

Results Point of Contact

• Title: Éric Lefebvre, M.D., Chief Medical Officer
• Organization: Pliant Therapeutics, Inc.

ELefebvre@pliantrx.com

1-650-481-6779

Study Officials

• Pliant Therapeutics

  Pliant Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 25, 2020
• Study Start: October 22, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 2, 2021
• Last Updated: November 17, 2022
• Results First Posted: November 17, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)