Trial Outcomes & Findings for 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 (NCT NCT04565249)

Last Updated: 2022-11-17

Results Overview

Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit

Results posted on

2022-11-17

Participant Flow

The study was discontinued prior to completion of enrollment of Dose 1 due to the lack of participant availability following the introduction of COVID-19 vaccines as well as the increased and successful measures to contain the virus leading to a dramatic decrease in the number of severe and critical COVID-19 patients with ARDS.

Participant milestones

Participant milestones
Measure	PLN-74809: Dose 1 (40 mg) N=5	Placebo N=1
Overall Study STARTED	5	1
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PLN-74809: Dose 1 (40 mg) N=5	PLN-74809: Dose 2 (80 mg) not enrolled (study discontinued)	PLN-74809: Dose 3 (160 mg) not enrolled (study discontinued)	Placebo N=1
Overall Study Death	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PLN-74809: Dose 1 (40 mg) n=5 Participants N=5	PLN-74809: Dose 2 (80 mg) not enrolled (study discontinued)	PLN-74809: Dose 3 (160 mg) not enrolled (study discontinued)	Placebo n=1 Participants N=1	Total n=6 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 6.54 • n=5 Participants	—	—	58.0 years STANDARD_DEVIATION 0 • n=4 Participants	57.5 years STANDARD_DEVIATION 5.86 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	—	—	0 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	—	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	—	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	—	—	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit

Population: 5 Participant received PLN-74809 and 1 participant received Placebo

Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.

Outcome measures

Outcome measures
Measure	PLN-74809: Dose Level 1 (40 mg) n=5 Participants N=5	PLN-74809: Dose Level 2 (80 mg) Not enrolled (study discontinued)	PLN-74809: Dose Level 3 (160 mg) Not enrolled (study discontinued)	Placebo n=1 Participants N=1
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0	0 participants	—	—	0 participants

Adverse Events

PLN-74809: Dose Level 1 (40 mg)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

PLN-74809: Dose Level 2 (80 mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PLN-74809: Dose Level 3 (160 mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	PLN-74809: Dose Level 1 (40 mg) n=5 participants at risk N=5	PLN-74809: Dose Level 2 (80 mg) not enrolled (study discontinued)	PLN-74809: Dose Level 3 (160 mg) not enrolled (study discontinued)	Placebo n=1 participants at risk N=1
Investigations Respiratory rate increased	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Gastrointestinal disorders Intestinal Dilatation	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Gastrointestinal disorders Abdominal Compartment Syndrome	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Cardiac disorders Ventricular Tachycardia	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Cardiac disorders Cardiac Arrest	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	40.0% 2/5 • Number of events 2 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.

Other adverse events

Additional Information

Éric Lefebvre, M.D., Chief Medical Officer

Pliant Therapeutics, Inc.

Phone: 1-650-481-6779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	PLN-74809: Dose Level 1 (40 mg) n=5 participants at risk N=5	PLN-74809: Dose Level 2 (80 mg) not enrolled (study discontinued)	PLN-74809: Dose Level 3 (160 mg) not enrolled (study discontinued)	Placebo n=1 participants at risk N=1
Cardiac disorders Bradycardia	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Cardiac disorders Cardiac Aneurysm	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Cardiac disorders Coronary Artery Disease	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Infections and infestations Conjunctivitis	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Infections and infestations Urinary Tract Infection	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Investigations Alanine Aminotransferase Increased	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Investigations Aspartate Aminotransferase Increased	40.0% 2/5 • Number of events 2 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Investigations Electrocardiogram QT Prolonged	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Investigations Klebsiella Test Positive	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Investigations Staphylococcus Test Positive	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Investigations Stenotrophomonas Test Positive	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/5 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Renal and urinary disorders Acute Kidney Injury	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	100.0% 1/1 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Vascular disorders Deep Vein Thrombosis	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Vascular disorders Embolism	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.
Vascular disorders Hypertension	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	— 0/0 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.	0.00% 0/1 • Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit. No participants were enrolled in Doses 2 and 3.