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

Sponsor
Attgeno AB (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04885491
Collaborator
Vinnova (Other)
16
Enrollment
2
Locations
2
Arms
15.3
Anticipated Duration (Months)
8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Starting with an observational period with placebo treatment and then starting the treatment with PDNOStarting with an observational period with placebo treatment and then starting the treatment with PDNO
Masking:
Single (Participant)
Masking Description:
The treatment is blinded for the subjects.
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of the Two Regioisomers 1-(Nitrosooxy)Propan-2-ol and 2- (Nitrosooxy)Propan-1-ol (PDNO) Infusion in Covid-19 Patients With Acute Pulmonary Hypertension.
Actual Study Start Date :
May 7, 2021
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment arm

Observational period with placebo treatment and then experimental treatment

Drug: Placebo
Observational period with placebo infusion during 2 hours.
Other Names:
  • Sodium Chloride

    		•
    Placebo Comparator: Observational period (placebo)

    Starting with observational period with placebo treatment

    Drug: PDNO
    Infusion of PDNO. Starting with dose escalating and then treatment up to 8 hours.
    Other Names:
  • Nitrosooxypropanol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the efficacy of PDNO on in patients with Covid-19 and pulmonary hypertension (PH). [During 24 hours]

      Pulmonary vascular resistance (PVR) and mean pulmonary artery pressure (MPAP)

    Secondary Outcome Measures

    1. To evaluate the safety of PDNO in patients with COVID-19. [Through study completion during 30 days]

      Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    2. To evaluate general clinical outcome [Through study completion during 30 days]

      Number of participants respectively with the following outcome dead, intubated at the ICU, non-intubated at the ICU, discharged from ICU to other hospital care or discharged to home.

    3. To decide the time to non-SARS-CoV-2 infection [7 days]

      Levels of SARS-CoV-2

    4. To evaluate the change in troponin I/T and BNP/NT-proBNP after PDNO dosing in patients with Covid-19 and PH [7 days]

      Levels of troponin and BNP/NT-proBNP

    5. To evaluate the efficacy of PDNO [1 day]

      The pulmonary resistance

    Other Outcome Measures

    1. To assess presence of SARS-CoV-2 virus [7 days]

      Levels of SARS-CoV-2 virus in plasma and in secret

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danderyd Hospital Danderyd Sweden 18257
    2 Örebro University Hospital Örebro Sweden 70116

    Sponsors and Collaborators

    • Attgeno AB
    • Vinnova

    Investigators

    • Principal Investigator: Johanna Savilampi, MD, Region Örebro County
    • Principal Investigator: Piotr Harbut, MD, Danderyd Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Attgeno AB
    ClinicalTrials.gov Identifier:
    NCT04885491
    Other Study ID Numbers:
    • 2020-PDNO-002
    First Posted:
    May 13, 2021
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Attgeno AB
    acute
    Additional relevant MeSH terms:
    COVID-19
    Hypertension, Pulmonary
    Hypertension

    Study Results

    No Results Posted as of Feb 15, 2022