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

January 25, 2023 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized adult patients in intensive care units in the US

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of known, expected, or unanticipated adverse device effects
Time Frame: 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
From the initiation of therapy through 24 hours after therapy has been completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiovascular hemodynamic stability
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in cardiovascular hemodynamic support
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in pulmonary/respiratory status
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed
Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC
Time Frame: 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
24 hours prior to therapy through 24 hours after therapy has been completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

ExThera Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-Seraph®-100 for SARS-CoV-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Seraph®-100 Microbind® Affinity Blood Filter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe