PMX-DHP for COVID-19

JRCT ID: jRCTs032200131

Registered date:28/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 28/09/2020
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Device used: Product name: Toraymyxin PMX-20R (Toray Industries, Inc.) polymyxin B-filled polystyrene derivative fiber-filled blood purifier
Treatment: flow rate 60-120 mL/min, 3-6 hours per bottle of tremyxin (up to 24 hours), with a minimum of 2 bottles (up to 3) to be used and followed up to 4 weeks after completion of PMX therapy.

Outcome(s)

• Primary Outcome: Percentage of patients who had an improvement of 1 or more from the 4.5.6 condition on Day15 in the eight-category evaluation.

Secondary Outcome

Percentage of patients who improved.
Improvement in Day 4 and Day 8 P/F ratio.
Changes in cytokines, coagulation system markers, and urine biomarkers.
Changes in cytokines, coagulation markers, and urine biomarkers.
Ventilator avoidance rate and duration of ventilator placement.
ECMO avoidance rate, ECMO duration.
Mortality rates.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Dyspnea that cannot be explained by other diseases (heart failure, renal failure, etc.)
2)SARS-CoV-2 infection has been diagnosed by PCR or LAMP within 1 week
3)chest image shows pneumonia
4)P/F ratio is 300 or less, or SpO2 93% (room air) or less
5)Applicable to any of the following in the eight-category evaluation *
4, hospitalized, requiring supplemental oxygen
5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
6. requiring invasive mechanical ventilation
6)16 years or older
7)Have written consent from the patient or legal representative

Exclude criteria

1)Patients with severe progression of multiple organ failure
2) P/F ratio is 100 or less
3)implementing ECMO
4)hospitalized for more than 15 days
5)platelet count of 20,000 /microL or less
6)received cytotoxic or biological treatment within 4 weeks before consent
7)received TNF inhibitor within 2 weeks before consent
8)received recovering plasma or intravenous immunoglobulin against COVID-19
9) A person whose inclusion in the research is deemed inappropriate by the principal investigator or sub-researcher

Related Information

• Primary Sponsor: Izumi Shinnyuu
• Source(s) of Monetary Support: Toray Industries, Inc.,National Center for Global Health and Medicine