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Completed

NCT Number: NCT04413955

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seraph®-100 Microbind® Affinity Blood Filter

Device

Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood

Other names: Seraph

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • ExThera Medical Corporation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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