Status:
WITHDRAWN
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension
Lead Sponsor:
Attgeno AB
Collaborating Sponsors:
Vinnova
Conditions:
Pulmonary Hypertension
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, multicentre study evaluating the effect, safety and tolerability of the two regioisomers 1-(nitrosooxy)propan-2-ol and 2-(nitrosooxy)propan-1-ol (PDNO) infusion given to COVID-1...
Eligibility Criteria
Inclusion
- Ability to understand and willing to sign an ICF
- 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
- History of chronic pulmonary hypertension (PH), as judged by the Investigator at screening
- 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
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04885491
Start Date
May 7 2021
End Date
April 30 2023
Last Update
August 1 2023
Active Locations (2)
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1
Danderyd Hospital
Danderyd, Sweden, 182 88
2
Örebro University Hospital
Örebro, Sweden, 701 85