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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)
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.
Danderyd Hospital
Danderyd, Sweden
Örebro University Hospital
Örebro, Sweden
Change in MPAP and calculated PVR measured with PAC, at target dose after up-titration and 10 minutes after steady state.
Mean pulmonary arterial pressure (MPAP) and pulmonary vascular resistance (PVR), as measured with a pulmonary artery catheter (PAC).
Time frame: During 24 hours
Safety and tolerability of PDNO in patients with COVID-19, as measured by incidence of treatment-emergent AEs, SAEs, and AESI.
* Treatment-emergent adverse events (AEs) * Treatment-emergent serious AEs (SAEs) * Treatment-emergent AEs of special interest (AESI)
Time frame: Through study completion (i.e., Day 30)
Safety and tolerability of PDNO in patients with COVID-19, as measured by incidence of treatment-emergent changes in vital signs, ECG abnormalities, and laboratory abnormalities.
* Treatment-emergent changes in vital signs (blood pressure, pulse, oxygen saturation, respiratory frequency, body temperature) * Treatment-emergent electrocardiogram (ECG) abnormalities * Treatment-emergent laboratory abnormalities
Time frame: From baseline until Day 7
Number of participants with the following clinical outcome (dead, intubated at the intensive care unit [ICU], non-intubated at the ICU, discharged from ICU to other hospital care or discharged to home).
Time frame: At Days 7, 14, 21, and 30.
Time to obtain first negative upper respiratory tract sample in the SARS-CoV-2-rt-PCR assay
Time frame: From Day 1 to Day 14
Change in troponin I/T and BNP/NT-proBNP
Time frame: From end of PDNO infusion to Day 7.
Change in the ratio PVR/SVR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pulmonary vascular resistance (PVR) and systemic vascular resistance (SVR) will be calculated from the obtained values according to the following formulas: PVR= (mean pulmonary arterial pressure \[MPAP\] - pulmonary capillary wedge pressure \[PCWP\])/cardiac output (CO) SVR= (mean arterial pressure \[MAP\] - central venous pressure \[CVP\])/CO Ratio of PVR to SVR = PVR/SVR
Time frame: During 24 hours