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.
Investigators
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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