A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension

Study Purpose

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-19 patients with acute pulmonary hypertension (aPH) and/or acute cor pulmonale (ACP).

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:

  • - 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 Criteria:

  • - 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

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.

Cecilia Kemi, PhD
Principal Investigator Affiliation Attgeno AB
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.

Pulmonary Hypertension, COVID-19
Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - Sodium chloride (placebo)

Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)

Drug: - 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.

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, , 182 88

Site Contact

Piotr Harbut, MD

christofer.adding@attgeno.com

+46 (0) 70 788 67 66

Örebro University Hospital, Örebro, Sweden

Status

Recruiting

Address

Örebro University Hospital

Örebro, , 701 85

Site Contact

Johanna Savilampi, MD

christofer.adding@attgeno.com

+46 (0) 70 788 67 66

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

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