Clinical trial NCT04413955: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV 2
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: ExThera Medical Corporation
First posted: 2020-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized adult patients in intensive care units in the US

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.


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

Primary outcomes:
measure: Rate of known, expected, or unanticipated adverse device effects
timeFrame: From the initiation of therapy through 24 hours after therapy has been completed
Secondary outcomes:
measure: Change in cardiovascular hemodynamic stability
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in cardiovascular hemodynamic support
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in pulmonary/respiratory status
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC
timeFrame: 24 hours prior to therapy through 24 hours after therapy has been completed
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
citation: 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.