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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-08-02

Brief Summary

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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

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Detailed Description

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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

Conditions

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Acute Respiratory Distress Syndrome SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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PLN-74809

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No