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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome SARS-CoV-2 Drug: PLN-74809 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PLN-74809 Dose 1
Dose level 1 of PLN-74809
 Drug: PLN-74809
PLN-74809

Drug: Placebo
Placebo
Experimental: PLN-74809 Dose 2
Dose level 2 of PLN-74809
 Drug: PLN-74809
PLN-74809

Drug: Placebo
Placebo
Experimental: PLN-74809 Dose Level 3
Dose level 3 of PLN-74809
 Drug: PLN-74809
PLN-74809

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events and laboratory abnormalities, assessed by CTCAE V5.0 [ Time Frame: Up to 90 days ]

Secondary Outcome Measures :
  1. Assessment of PLN-74809 plasma concentrations [ Time Frame: up to 14 days ]

Other Outcome Measures:
  1. Number of participants alive and free of invasive mechanical ventilation [ Time Frame: up to 28 days ]
  2. Number of participants alive and discharged from hospital [ Time Frame: Up to 28 days ]
  3. Number of participants alive and discharged from hospital [ Time Frame: Up to 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565249


Contacts
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Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com

Locations
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United States, Arizona
Valleywise Health Medical Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Rania Rahman, MD         
Principal Investigator: Rania Rahman         
United States, Florida
Advent Health Recruiting
Orlando, Florida, United States, 32803
Contact: Amay Parikh, MD         
Principal Investigator: Amay Parikh, MD         
Sponsors and Collaborators
Pliant Therapeutics, Inc.
Investigators
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Study Director: Pliant Therapeutics Pliant Therapeutics, Inc.
More Information
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Responsible Party: Pliant Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04565249    
Other Study ID Numbers: PLN-74809-ARDS-204
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury