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Trial - NCT04565249


Column Value
Trial registration number NCT04565249
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04565249

First author
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

Pliant Therapeutics Medical Monitor

Contact
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

clintrials@pliantrx.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-25

Recruitment status
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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).

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Pliant Therapeutics, Inc.

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 30, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

6

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Number of participants with treatment-related adverse events and laboratory abnormalities, assessed by CTCAE V5.0

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1004, "treatment_name": "Pln-74809", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1004, "treatment_name": "Pln-74809", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1004, "treatment_name": "Pln-74809", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]