A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension
NCT ID: NCT04885491
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2021-05-07
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment with PDNO
Placebo treatment administered during the 120-minute observation period, followed by PDNO infusion. PDNO administered as an i.v. infusion of 5-15 minutes, respectively, for the increased planned dose titration steps: 3, 10 and thereafter steps of max 10 nmol/kg/min until the target effect on the mean pulmonary arterial pressure/pulmonary vascular resistance (MPAP/PVR) or a maximal dose of 120 nmol/kg/min is reached.
After 4 patients have been treated, the internal safety review committee (iSRC) will decide if the start dose will be increased. The new start dose could be in the interval 1 to 5 nmol/kg/min.
Sodium chloride (placebo)
Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)
PDNO
PDNO consists of propylene glycol (1,2-propanediol, PD) chemically combined with NO (to be donated). The drug substance is formulated as an inherent mixture of 4 structure analogues. The mixture consists of an equilibrium of the 2 regioisomers 1-(nitrosooxy) propan-2-ol and 2-(nitrosooxy) propan-1-ol. In addition, each regioisomer is a racemic mixture.
Interventions
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Sodium chloride (placebo)
Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)
PDNO
PDNO consists of propylene glycol (1,2-propanediol, PD) chemically combined with NO (to be donated). The drug substance is formulated as an inherent mixture of 4 structure analogues. The mixture consists of an equilibrium of the 2 regioisomers 1-(nitrosooxy) propan-2-ol and 2-(nitrosooxy) propan-1-ol. In addition, each regioisomer is a racemic mixture.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female patients at least 18 years of age
* Diagnosed with COVID-19 at admission to the ICU
* Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) \> 40 mmHg
Exclusion Criteria
* Known New York Heart Association (NYHA) Functional Class III or IV symptoms
* Left heart failure with ejection fraction (EF) \< 35%
* Acute coronary syndrome
* Body Mass Index (BMI) \> 45 kg/m\^2
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min
* MetHb \> 3%
* PCO2 \> 7
* Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) at screening
* Haemoglobin \< 80 g/dL
* Thrombocytopenia (platelet count \< 80000/mm\^3)
* Prothrombin time International ratio (INR) \> 1.4
* Pregnancy, or a positive pregnancy test
* Ongoing daily treatment the last 3 days with non-steroidal anti-inflammatory drugs
* Known active malignancy within the past 3 years
* History of allergy/hypersensitivity to PD or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to PDNO
* History of any other clinically significant disease or disorder
* Participation in any interventional clinical study
18 Years
ALL
No
Sponsors
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Vinnova
OTHER_GOV
Attgeno AB
INDUSTRY
Responsible Party
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Principal Investigators
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Cecilia Kemi, PhD
Role: STUDY_DIRECTOR
Attgeno AB
Locations
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Danderyd Hospital
Danderyd, , Sweden
Örebro University Hospital
Örebro, , Sweden
Countries
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Other Identifiers
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2020-PDNO-002
Identifier Type: -
Identifier Source: org_study_id
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