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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04413955
• Other study ID #: 001-Seraph®-100 for SARS-CoV-2
• Status: Enrolling by invitation
• Start date: June 1, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

1. Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)

2. 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

3. Life-threatening disease, defined as:

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

Exclusion Criteria:

• No Exclusion

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

Device:
• Seraph®-100 Microbind® Affinity Blood Filter
Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	ExThera Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of known, expected, or unanticipated adverse device effects	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	From the initiation of therapy through 24 hours after therapy has been completed
Secondary	Change in cardiovascular hemodynamic stability	Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in cardiovascular hemodynamic support	Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in pulmonary/respiratory status	Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6	Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP	Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin	Measure change in Ferritin before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer	Measure change in D-Dimer before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed
Secondary	Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC	Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device	24 hours prior to therapy through 24 hours after therapy has been completed