Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study

Launched by HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE · Oct 27, 2020

Keywords

ClinConnect Summary

This is a multi-center, observational study that will enroll 1) patients with severe COVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients (medical record data) that have been previously treated with the Seraph® 100 after the date of the EUA approval (17 April 2020), but before the date that the study is approved at the study site, and 3) a convenience sample of patients (medical record data) in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection, meeting the EUA treatment criteria, but not ...

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Eligibility criteria

• Inclusion Criteria:
• • Prospective Seraph® 100
• • 1. Subject must be 18 years of age
• 2. Per the FDA Approve EUA:
• Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:
• • 1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
• 2. Severe disease, defined as:
• • 1. Dyspnea,
• • 2. Respiratory frequency ≥ 30/min,
• • 3. Blood oxygen saturation ≤ 93%,
• • 4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300, and/or
• • 5. Lung infiltrates \> 50% within 24 to 48 hours; or
• 3. Life-threatening disease, defined as:
• • 1. Respiratory failure,
• • 2. Septic shock, and/or
• • 3. Multiple organ dysfunction or failure. 2. Prospective study patients (or their Legally Authorized Representative (LAR)) provides informed consent. Patients or their legally authorized representative will be consented in their main language if they are not fluent in English.
• • 3. Prospective study patient is willing to complete all study visits as required by the protocol 4. For Military Treatment Facility (MTF) enrollment only - must be DEERS eligible for care at the MTF
• • Retrospective Seraph® 100
• • 1. Subject must be 18 years of age
• 2. Per the FDA Approve EUA:
• Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:
• • 1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
• 2. Severe disease, defined as:
• • 1. Dyspnea,
• • 2. Respiratory frequency ≥ 30/min,
• • 3. Blood oxygen saturation ≤ 93%,
• • 4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300, and/or
• • 5. Lung infiltrates \> 50% within 24 to 48 hours; or
• 3. Life-threatening disease, defined as:
• • 1. Respiratory failure,
• • 2. Septic shock, and/or
• • 3. Multiple organ dysfunction or failure.
• • 3. Treated with Seraph® 100 from 17 April 2020 (date of EUA approval) to the date of study approval at the study site.
• • Historical Control
• • 1. Subject must be 18 years of age
• 2. Per the FDA Approve EUA:
• Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:
• • 1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
• 2. Severe disease, defined as:
• • 1. Dyspnea
• • 2. Respiratory frequency ≥ 30/min,
• • 3. Blood oxygen saturation ≤ 93%,
• • 4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300, and/or
• • 5. Lung infiltrates \> 50% within 24 to 48 hours; or
• 3. Life-threatening disease, defined as:
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• • 1. Respiratory failure,
• • 2. Septic shock, and/or
• • 3. Multiple organ dysfunction or failure.
• • 3. Hospitalized from 20 January 2020 to the date of study approval at the study site.
• Exclusion Criteria:
• • Prospective
• • 1. Unwilling to provide informed consent
• • 2. Unable to provide informed consent and no LAR available to provide permission
• • Retrospective No specific exclusion criteria. However, patients treated with Seraph® 100 prior to approval of the study at a site and who remains admitted to the hospital at the time the study is approved, will be given the opportunity to participate in the study by signing consent for their health data to be collected (and not biospecimens).
• Historical Controls:
• • Patients who remain admitted to the hospital at the time that the study is approved at the study site will be excluded.