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Study halted and will not resume; participants are no longer being examined or receiving intervention
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLN-74809 Dose Level1 | Experimental | Dose Level 1 of PLN-74809 |
|
| PLN-74809 Dose Level 2 | Experimental | Dose Level 2 of PLN-74809 |
|
| PLN74809 Dose Level 3 | Experimental | Dose Level 3 of PLN-74809 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLN-74809 | Drug | PLN-74809 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0 | Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5. | Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pliant Therapeutics | Pliant Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valleywise Health Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Cedars-Sinai Medical Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PLN-74809: Dose 1 (40 mg) | N=5 |
| FG001 | PLN-74809: Dose 2 (80 mg) | not enrolled (study discontinued) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2020 | Sep 20, 2022 |
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| Placebo | Drug | Placebo |
|
| Los Angeles |
| California |
| 90048 |
| United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Advent Health | Orlando | Florida | 32803 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Atlantic Health System | Summit | New Jersey | 07960 | United States |
| FG002 |
| PLN-74809: Dose 3 (160 mg) |
not enrolled (study discontinued) |
| FG003 | Placebo | N=1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Study was discontinued before completion of enrollment of Dose 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | PLN-74809: Dose 1 (40 mg) | N=5 |
| BG001 | PLN-74809: Dose 2 (80 mg) | not enrolled (study discontinued) |
| BG002 | PLN-74809: Dose 3 (160 mg) | not enrolled (study discontinued) |
| BG003 | Placebo | N=1 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0 | Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5. | 5 Participant received PLN-74809 and 1 participant received Placebo | Posted | Number | participants | Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit |
|
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLN-74809: Dose Level 1 (40 mg) | N=5 | 0 | 5 | 3 | 5 | 5 | 5 |
| EG001 | PLN-74809: Dose Level 2 (80 mg) | not enrolled (study discontinued) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | PLN-74809: Dose Level 3 (160 mg) | not enrolled (study discontinued) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Placebo | N=1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory rate increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal Dilatation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Compartment Syndrome | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac Aneurysm | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Klebsiella Test Positive | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Staphylococcus Test Positive | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Stenotrophomonas Test Positive | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
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. As a result, the study did not reach the target number of participants needed to achieve target power and statistically reliable results.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Éric Lefebvre, M.D., Chief Medical Officer | Pliant Therapeutics, Inc. | 1-650-481-6779 | ELefebvre@pliantrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2021 | Sep 20, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|