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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413955
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
ExThera Medical Corporation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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
COVID-19 SARS-CoV 2 Device: Seraph®-100 Microbind® Affinity Blood Filter

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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
    Other Name: Seraph


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized adult patients in intensive care units in the US
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413955


Locations
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United States, Florida
AdventHealth Orlando
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
ExThera Medical Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: June 4, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases