Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04413955

Collaborator

ExThera Medical Corporation (Industry)

100

Enrollment

Location

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV 2	Device: Seraph®-100 Microbind® Affinity Blood Filter

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Rate of known, expected, or unanticipated adverse device effects [From the initiation of therapy through 24 hours after therapy has been completed]
Monitor and report on adverse events and unanticipated adverse device effects experienced by patients receiving treatment with the Seraph®-100 for COVID-19, including but not limited to: bleeding, clotting, cardiac dysrhythmia, hypotension, increase in oxygen requirement, hemolytic anemia, and allergic/anaphylactic reaction

Secondary Outcome Measures

Change in cardiovascular hemodynamic stability [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device
Change in cardiovascular hemodynamic support [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device
Change in pulmonary/respiratory status [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6 [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in Ferritin before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in D-Dimer before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC [24 hours prior to therapy through 24 hours after therapy has been completed]
Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed COVID-19 infection
Confirmed or imminent respiratory failure
At least one of the following conditions

Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)
Severe disease, defined as:

dyspnea,
respiratory frequency ≥ 30 bpm,
blood oxygen saturation ≤ 93%,
partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
lung infiltrates > 50% within 24 to 48 hours

Life-threatening disease, defined as:

respiratory failure,
septic shock, and/or
multiple organ dysfunction or failure

Exclusion Criteria:

No Exclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdventHealth Orlando	Orlando	Florida	United States	32803

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati
ExThera Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT04413955

Other Study ID Numbers:

001-Seraph®-100 for SARS-CoV-2

First Posted:

Jun 4, 2020

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 16, 2021