COVID-19 COVID-19
Conditions
Interventions
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
Sponsors
Izumi Shinnyuu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactDaisuke Katagiri
National Center for Global Health and Medicine
Outcome results
None listed