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

• Status: Terminated
• Trial end date: 2021-08-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pliant Therapeutics, Inc.

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).