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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04885491
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Attgeno AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Johanna Savilampi, MDPiotr Harbut, MD
Principal Investigator Affiliation Region Örebro CountyDanderyd Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary, Covid19
Additional Details

This is an open-label, multicentre study to evaluate the efficacy, 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) and/or Acute Cor Pulmonale (ACP). PDNO is developed to be used as part of peri- and post-operative pulmonary hypåertension (PH) treatment in adults in conjunction to heart surgery, to selectively decrease pulmonary arterial pressure and improve Right ventricular (RV) function and oxygenation. Current treatment options for aPH in patients with COVID-19 are limited. In addition to the hemodynamic effects, it is believed to be beneficial to use an iv-administered lung-selective Nitrogen Oxide (NO) donor that will more effectively reach affected areas in the lung and give maximal NO-exposure to the endothelium. The potential antiviral effects of NO, by inhibition of receptor binding and inhibition of earlystage virus replication, are also part of the rational to evaluate the benefits of using of PDNO in COVID-19 patients.

Arms & Interventions

Arms

Experimental: Treatment arm

Observational period with placebo treatment and then experimental treatment

Placebo Comparator: Observational period (placebo)

Starting with observational period with placebo treatment

Interventions

Drug: - Placebo

Observational period with placebo infusion during 2 hours.

Drug: - PDNO

Infusion of PDNO. Starting with dose escalating and then treatment up to 8 hours.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Danderyd Hospital, Danderyd, Sweden

Status

Recruiting

Address

Danderyd Hospital

Danderyd, , 18257

Site Contact

Piotr Harbut, MD

claes.jagensjo@attgeno.com

+46761464911

Örebro University Hospital, Örebro, Sweden

Status

Recruiting

Address

Örebro University Hospital

Örebro, , 70116

Site Contact

Johanna Savilampi, MD

claes.jagensjo@attgeno.com

+46761464911

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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