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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

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ClinicalTrials.gov Identifier: NCT04565249
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 25, 2020
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE October 22, 2020
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
Number of participants with treatment-related adverse events and laboratory abnormalities, assessed by CTCAE V5.0 [ Time Frame: Up to 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
Assessment of PLN-74809 plasma concentrations [ Time Frame: up to 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 24, 2020)
  • Number of participants alive and free of invasive mechanical ventilation [ Time Frame: up to 28 days ]
  • Number of participants alive and discharged from hospital [ Time Frame: Up to 28 days ]
  • Number of participants alive and discharged from hospital [ Time Frame: Up to 90 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • SARS-CoV-2
Intervention  ICMJE
  • Drug: PLN-74809
    PLN-74809
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PLN-74809 Dose 1
    Dose level 1 of PLN-74809
    Interventions:
    • Drug: PLN-74809
    • Drug: Placebo
  • Experimental: PLN-74809 Dose 2
    Dose level 2 of PLN-74809
    Interventions:
    • Drug: PLN-74809
    • Drug: Placebo
  • Experimental: PLN-74809 Dose Level 3
    Dose level 3 of PLN-74809
    Interventions:
    • Drug: PLN-74809
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04565249
Other Study ID Numbers  ICMJE PLN-74809-ARDS-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pliant Therapeutics, Inc.
Study Sponsor  ICMJE Pliant Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pliant Therapeutics Pliant Therapeutics, Inc.
PRS Account Pliant Therapeutics, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP