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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

Tracking Information
First Submitted Date May 19, 2020
First Posted Date June 4, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date June 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 2, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: June 2, 2020)
  • Decrease in laboratory measures of cytokine reactions and/or viral sepsis [ Time Frame: 24 hours prior to therapy through 24 hours after therapy has been completed ]
    Measure differences in IL-6, C-Reactive Protein, Ferritin, D-Dimer, and Lymphocyte Count before and after treatment with the Seraph®-100 device
  • Improvement in cardiovascular hemodynamic stability [ Time Frame: 24 hours prior to therapy through 24 hours after therapy has been completed ]
    Measure differences in Mean Arterial Pressure and required Vasopressor Dosages before and after treatment with the Seraph®-100 device
  • Improvement in pulmonary/respiratory status [ Time Frame: 24 hours prior to therapy through 24 hours after therapy has been completed ]
    Measure differences in required Respiratory Support before and after treatment with the Seraph®-100 device
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA
Official Title Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalized adult patients in intensive care units in the US
Condition
  • 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
Other Name: Seraph
Study Groups/Cohorts Not Provided
Publications * Sun X, Yang S, Al-Dossary AA, Broitman S, Ni Y, Guan M, Yang M, Li J. Nanobody-Functionalized Cellulose for Capturing SARS-CoV-2. Appl Environ Microbiol. 2022 Mar 8;88(5):e0230321. doi: 10.1128/aem.02303-21. Epub 2022 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 2, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04413955
Other Study ID Numbers 001-Seraph®-100 for SARS-CoV-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Children's Hospital Medical Center, Cincinnati
Original Responsible Party Same as current
Current Study Sponsor Children's Hospital Medical Center, Cincinnati
Original Study Sponsor Same as current
Collaborators ExThera Medical Corporation
Investigators Not Provided
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date September 2021