A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Covid-19 Patients With aPH
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Hypertension Pulmonary
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Starting with an observational period with placebo treatment and then starting the treatment with PDNOMasking: Single (Participant)Masking Description: The treatment is blinded for the subjects.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 de...
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.
Tracking Information
- NCT #
- NCT04885491
- Collaborators
- Vinnova
- Investigators
- Principal Investigator: Johanna Savilampi, MD Region Örebro County Principal Investigator: Piotr Harbut, MD Danderyd Hospital
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