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Clinical Trials/JPRN-jRCTs032200131
JPRN-jRCTs032200131
Active, Not Recruiting
Phase 2

Exploratory study on the efficacy and safety of Direct hemoperfusion using polymyxin B-immobilized polystyrene column (PMX-DHP) for COVID-19 patients - X-CODE

Izumi Shinnyuu0 sites30 target enrollmentSeptember 28, 2020

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Izumi Shinnyuu
Enrollment
30
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 28, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Izumi Shinnyuu

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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