A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Covid-19 Patients With aPH

• Status: Recruiting
• Trial end date: 2021-08-15
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicentre study evaluating the effect, safety and tolerability of the two regio isomers 1-(nitrosooxy)propan-2-ol and 2- (nitrosooxy)propan-1-ol (PDNO) infusion given to COVID-19 patients with acute pulmonary hypertension (aPH).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Attgeno AB
• Collaborator: Vinnova

Criteria

Inclusion Criteria:

1. Ability to understand and willing to sign an ICF.

2. Male and female patients, age at least 18 years.

3. Diagnosed with COVID-19 at admission to the ICU.

4. Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) >40 mmHg.

Exclusion Criteria:

1. History of chronic PH, as judged by the Investigator at screening

2. Known New York Heart Association (NYHA) Functional Class III or IV symptoms

3. Left heart failure with ejection fraction (EF) < 35 %

4. Acute coronary syndrome

5. Body Mass Index (BMI) > 40 kg/m2

6. Estimated glomerular filtration rate (eGFR) < 30 mL/min

7. MetHb >3%

8. PCO2 > 7

9. 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

10. Haemoglobin <80 g/dL

11. Thrombocytopenia (platelet count <80000/mm3)

12. Prothrombin time International ratio (INR) > 1.4

13. Pregnancy, or a positive pregnancy test

14. Ongoing daily treatment the last 3 days with non-steroidal anti-inflammatory drugs

15. Known active malignancy within the past 3 years

16. 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.

17. History of any other clinically significant disease or disorder

18. Participation in any interventional clinical study