Related Experiment Video
Updated: Aug 28, 2025
Artificial Lung Device Priming for In Situ Fiber Bundle Surface Grafting
Published on: March 28, 2025
Efficacy and Safety of Direct Hemoperfusion Using Polymyxin B-Immobilized Polystyrene Column for Patients With
Junko Terada-Hirashima1, Shinyu Izumi2, Daisuke Katagiri3
1Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
Background:
Polymyxin B-immobilized fiber column (PMX; Toraymyxin column) was approved for the relief of systemic inflammatory response syndrome caused by bacterial infection or endotoxemia. PMX reduces lung damage by removing leukocytes and cytokines in addition to endotoxin removal in the setting of idiopathic pulmonary fibrosis. Acute exacerbation of interstitial pneumonia pathologically presents with diffuse alveolar damage (DAD). PMX direct hemoperfusion (PMX-DHP) demonstrated efficacy, improving oxygenation. The SARS-CoV-2 virus causes COVID-19, which emerged in December 2019. The condition may become severe about 1 week after onset, and respiratory failure rapidly develops, requiring intensive care management. A characteristic of COVID-19-related severe pneumonia is ground-glass opacities rapidly progressing in both lungs, which subsequently turn into infiltrative shadows. This condition could be classified as DAD. As for the congealing fibrinogenolysis system, D-dimer, fibrin/fibrinogen degradation product quantity, and prolonged prothrombin time were significant factors in nonsurviving COVID-19 cases, associated with aggravated pneumonia. Clinical trials are being conducted, but except for remdesivir and dexamethasone, no treatments have yet been approved. COVID-19 aggravates with the deterioration of oxygen saturation, decrease in lymphocytes, and the occurrence of an abnormal congealing fibrinogenolysis system, leading to diffuse lung damage. Once the condition transitions from moderate to severe, it is necessary to prevent further exacerbation by providing treatment that will suppress the aforementioned symptoms as soon as possible.
Objective:
This study aims to access treatment options to prevent the transition from acute exacerbation of interstitial pneumonia to DAD. The mechanism of action envisioned for PMX-DHP is to reduce congealing fibrinogenolysis system abnormalities and increase oxygenation by removing activated leukocytes and cytokines, which are risk factors for the aggravation of COVID-19-related pneumonia.
Methods:
We will conduct a multicenter, prospective, intervention, single-group study to evaluate the efficacy and safety of direct hemoperfusion using PMX-DHP for patients with COVID-19. Efficacy will be evaluated by the primary end point, which is the rate of Ordinal Scale for Clinical Improvement after PMX-DHP of at least 1 point from a status of 4, 5, or 6 on day 15. The effect of PMX-DHP will be estimated by setting a control group with background factors from non-PMX-DHP patients enrolled in the COVID-19 registry. This study will be carried out as a single-group open-label study and will be compared with a historical control. The historical control will be selected from the COVID-19 registry according to age, gender, and severity of pneumonia.
Results:
The study period is scheduled from September 28, 2020, through April 30, 2023. Patient enrollment was scheduled from the Japan Registry of Clinical Trials publication for March 31, 2022. Data fixation is scheduled for October 2022, with the publication of the results by March 2023.
Conclusions:
From a clinical perspective, PMX-DHP is expected to become an adjunctive therapy to address unmet medical needs and prevent the exacerbation from moderate to severe acute respiratory distress syndrome in COVID-19 cases.
International Registered Report Identifier (Irrid):
DERR1-10.2196/37426.
Insights
Polymyxin B-immobilized fiber column direct hemoperfusion (PMX-DHP) may prevent COVID-19 from progressing to severe lung damage. This therapy aims to reduce inflammatory markers and improve oxygenation in patients with severe pneumonia.
Area of Science:
- Critical Care Medicine
- Pulmonology
- Infectious Diseases
Background:
- Polymyxin B-immobilized fiber column (PMX-DHP) is approved for inflammatory conditions and shows promise in reducing lung damage.
- COVID-19 can rapidly progress to severe pneumonia and diffuse alveolar damage (DAD), characterized by respiratory failure and abnormal coagulation.
- Existing treatments for severe COVID-19 are limited, highlighting the need for novel therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of PMX-DHP in preventing the transition from acute exacerbation of interstitial pneumonia to DAD in COVID-19 patients.
- To assess PMX-DHP's potential to reduce inflammatory cytokines and leukocytes, and improve oxygenation.
- To explore PMX-DHP as an adjunctive therapy for severe COVID-19.
Main Methods:
- A multicenter, prospective, single-group study will evaluate PMX-DHP in COVID-19 patients.
- Efficacy will be measured by clinical improvement on the Ordinal Scale for Clinical Improvement.
- A historical control group from a COVID-19 registry will be used for comparison.
Main Results:
- Study period: September 28, 2020, to April 30, 2023.
- Patient enrollment: Scheduled through March 31, 2022.
- Data fixation and results publication: Scheduled for October 2022 and March 2023, respectively.
Conclusions:
- PMX-DHP is a potential adjunctive therapy for COVID-19.
- It may address unmet medical needs by preventing the exacerbation of acute respiratory distress syndrome.
- Further clinical evaluation is warranted to establish its role in managing severe COVID-19.
