Clinical trial NCT04565249: 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: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
SARS-CoV-2
Lead sponsor: Pliant Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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).

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
timeFrame: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valleywise Health Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Summit
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
affiliation: Pliant Therapeutics, Inc.
name: Pliant Therapeutics
role: STUDY_DIRECTOR
References: