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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome, SARS-CoV-2

In brief

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

Key facts

Study ID

NCT04565249

Run by

Pliant Therapeutics, Inc.

People needed

6

Starts

2020-10-22

Expected to finish

2021-08-02

Last updated by the study team

2022-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Valleywise Health Medical Center — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• National Jewish Health — Denver, Colorado, United States
• Advent Health — Orlando, Florida, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Atlantic Health System — Summit, New Jersey, United States

Full record on ClinicalTrials.gov

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