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

Pliant Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Acute Respiratory Distress Syndrome; SARS-CoV-2

Treatments: Drug: Placebo; Drug: PLN-74809

Study type: Interventional

Funder types: Industry

Identifiers

NCT04565249

PLN-74809-ARDS-204

Details and patient eligibility

About

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

Full 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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 3 patient groups

PLN-74809 Dose Level1

Experimental group

Description:

Dose Level 1 of PLN-74809

Treatment:

Drug: Placebo

Drug: PLN-74809

PLN-74809 Dose Level 2

Experimental group

Description:

Dose Level 2 of PLN-74809

Treatment:

Drug: Placebo

Drug: PLN-74809

PLN74809 Dose Level 3

Experimental group

Description:

Dose Level 3 of PLN-74809

Treatment:

Drug: Placebo

Drug: PLN-74809