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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

Sponsor
Pliant Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04565249
Collaborator
(none)
6
Enrollment
6
Locations
3
Arms
9.3
Actual Duration (Months)
1
Patient Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Actual Enrollment :
6 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 :
Oct 22, 2020
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Aug 2, 2021

Arms and Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Assessment of PLN-74809 plasma concentrations [up to 14 days]

Other Outcome Measures

  1. Number of participants alive and free of invasive mechanical ventilation [up to 28 days]

  2. Number of participants alive and discharged from hospital [Up to 28 days]

  3. Number of participants alive and discharged from hospital [Up to 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Valleywise Health Medical Center Phoenix Arizona United States 85008
2 Cedars-Sinai Medical Center Los Angeles California United States 90048
3 National Jewish Health Denver Colorado United States 80206
4 Advent Health Orlando Florida United States 32803
5 Augusta University Medical Center Augusta Georgia United States 30912
6 Atlantic Health System Summit New Jersey United States 07960

Sponsors and Collaborators

  • Pliant Therapeutics, Inc.

Investigators

  • Study Director: Pliant Therapeutics, Pliant Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pliant Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04565249
Other Study ID Numbers:
  • PLN-74809-ARDS-204
First Posted:
Sep 25, 2020
Last Update Posted:
Oct 18, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome

Study Results

No Results Posted as of Oct 18, 2021