COVID-19NCT04413955
Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA
An observational study of COVID-19 and SARS-CoV 2, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- Seraph®-100 Microbind® Affinity Blood Filter
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Jan 2022
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adult patients in intensive care units in the US
Who may be able to join
- 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,
Show all 14Show fewer
- 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
Who cannot join
- No Exclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- Seraph®-100 Microbind® Affinity Blood Filter
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seraph®-100 Microbind® Affinity Blood FilterDevice
Also called Seraph
Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of known, expected, or unanticipated adverse device effects
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
Measured: From the initiation of therapy through 24 hours after therapy has been completed
Secondary outcomes (8)
Change in cardiovascular hemodynamic stability
Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device
Measured: 24 hours prior to therapy through 24 hours after therapy has been completed
Change in cardiovascular hemodynamic support
Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device
Measured: 24 hours prior to therapy through 24 hours after therapy has been completed
Change in pulmonary/respiratory status
Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device
Measured: 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
Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device
Measured: 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
Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device
Measured: 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
Measure change in Ferritin before and after treatment with the Seraph®-100 device
Measured: 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
Measure change in D-Dimer before and after treatment with the Seraph®-100 device
Measured: 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
Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device
Measured: 24 hours prior to therapy through 24 hours after therapy has been completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- ExThera Medical Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413955
- Sponsor's protocol ID
- 001-Seraph®-100 for SARS-CoV-2
- Status last verified
- Feb 2025
- First submitted
- 19 May 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 34985974
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry
- ClinicalTrials.gov ID
- NCT04413955
- Acronym / sponsor ID
- 001-Seraph®-100 for SARS-CoV-2
- Conditions
- COVID-19, SARS-CoV 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- ExThera Medical Corporation
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients in intensive care units in the US
Key inclusion criteria (14 listed)
- Confirmed COVID-19 infection
- Confirmed or imminent respiratory failure
- At least one of the following conditions
Key exclusion criteria (1 listed)
- No Exclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seraph®-100 Microbind® Affinity Blood FilterAlso: SeraphUse of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood | Device | – |
Primary outcome
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
8 secondary outcomes
Change in cardiovascular hemodynamic stability
Time frame: 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
Change in pulmonary/respiratory status
Time frame: 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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 34985974Sun 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.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV 2, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of known, expected, or unanticipated adverse device effects (time frame: From the initiation of therapy through 24 hours after therapy has been completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.