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Since the availability of vaccines, a drastic drop in number of patients with increased PAP was observed and when the WHO re-categorized the COVID-19 pandemic from PHEIC to an "established and ongoing health issue" the study was withdrawn.
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| Name | Class |
|---|---|
| Vinnova | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with PDNO | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium chloride (placebo) | Drug | Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of PDNO in patients with COVID-19, as measured by incidence of treatment-emergent AEs, SAEs, and AESI. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of SARS-CoV-2 virus in plasma and sputum/tracheal secretion | From Day 1 to Day 2 | |
| Collection of plasma for future analysis of biomarkers such as nitrite and nitrate in plasma (µM) | From Day 1 to Day 7 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Kemi, PhD | Attgeno AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd Hospital | Danderyd | 182 88 | Sweden | |||
| Örebro University Hospital |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C000717227 | 1-(nitrosooxy)propan-2-ol and 2-(nitrosooxy)propan-1-ol drug combination |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Observational period with placebo treatment, followed by treatment with PDNO.
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| PDNO | Drug | 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. |
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| 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). | At Days 7, 14, 21, and 30. |
| Time to obtain first negative upper respiratory tract sample in the SARS-CoV-2-rt-PCR assay | From Day 1 to Day 14 |
| Change in troponin I/T and BNP/NT-proBNP | From end of PDNO infusion to Day 7. |
| Change in the ratio PVR/SVR | 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 | During 24 hours |
| Örebro |
| 701 85 |
| Sweden |
| D002318 |
| Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D017670 |
| Sodium Compounds |