COVID-19CP022NCT04547257
Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19
A study testing Seraph 100 in people with COVID-19, run by ExThera Medical Corporation at 5 sites in 2 countries.
Trial summary
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Seraph 100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 4 May 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with confirmed SARS-CoV-2 infection
- Be ≥ 18 years old and ≤90 years old
- Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points
- At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point
- Written or electronic consent of the subjects who are legally competent and have the capacity to give consent
Who cannot join
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- Have Child-Pugh Class C cirrhosis
- Have platelet count <30.000/uL
- Contraindications for heparin sodium for injection
Show all 11Show fewer
- Subjects demonstrating any contraindication for this treatment as described in the IFU
- Subjects with known allergy of polyethylene and copolyester
- Subjects with hospital-acquired SARS-CoV-2 infections
- Subject is held in an institution by court or official order
- Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, 63739
Vivantes Klinikum Neukölln
Berlin, 12351
Universitätsklinikum Essen
Essen, 45147
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinico San Carlos
Madrid, 28040
About this study
Official title: Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
Read the detailed description
This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection.
The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only).
Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.
- Conditions
- COVID-19
- Being tested
- Seraph 100
- Keywords
- COVID-19
- 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 100Device
Bloodfiltration with Seraph 100
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Extracorporeal therapy with Seraph 100 blood filter Receives: Device: Seraph 100 |
| Control | No intervention | patients receive antibiotics only as standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Organ failure
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours
Measured: 48 hours after initial treatment
Secondary outcomes (9)
Change in Organ Failure
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction)
Measured: Daily during ICU stay from the start of the initial treatment until day 4
All-cause mortality
All-cause mortality
Measured: 28 days
Organ dysfunction-free days
Organ dysfunction-free days
Measured: Daily during ICU stay (up to 28 days)
Intensive Care Unit (ICU) complications
Intensive Care Unit (ICU) complications
Measured: Daily during ICU stay (up to 28 days)
Ventilator-free days (VFDs)
Ventilator-free days (VFDs)
Measured: Daily during ICU stay (up to 28 days)
Length of stay (LOS) at ICU and hospital ward
Length of stay (LOS) at ICU and hospital ward
Measured: During ICU and hospital ward stay (up to 28 days)
Prognosis Factors
Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2)
Measured: From baseline up to 48 hours
Recurrence of sepsis
Recurrence of sepsis
Measured: 7 days
Persistence of sepsis
Persistence of sepsis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start4 May 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary objective is to demonstrate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the clinical improvement of SARS-CoV-2 infected patients, measured by the reduction of established and suspected prognostic parameters.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ExThera Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vivantes Clinic Neukölln
- Responsible party
- Sponsor
- Investigators
- Herwig Gerlach, Prof., Principal investigator, Vivantes Neukoelln Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547257
- Sponsor's protocol ID
- CP022
- Acronym
- CP022
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2020
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Sponsor will be responsible for determining whether to register the clinical investigation on www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of Medical Journal Editors guidelines, or any other applicable guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04547257
- Acronym / sponsor ID
- CP022 / CP022
- Conditions
- COVID-19
- Keywords
- COVID-19
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- ExThera Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Vivantes Clinic Neukölln
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Sep 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.
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
Detailed description
This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection.
The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only).
Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary objective is to demonstrate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the clinical improvement of SARS-CoV-2 infected patients, measured by the reduction of established and suspected prognostic parameters.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Seraph 100Extracorporeal therapy with Seraph 100 blood filter |
| Control | No intervention | –patients receive antibiotics only as standard of care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with confirmed SARS-CoV-2 infection
- Be ≥ 18 years old and ≤90 years old
- Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points
- At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point
- Written or electronic consent of the subjects who are legally competent and have the capacity to give consent
Key exclusion criteria (11 listed)
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- Have Child-Pugh Class C cirrhosis
- Have platelet count <30.000/uL
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 100Bloodfiltration with Seraph 100 | Device | Treatment |
Primary outcome
Change in Organ failure
Time frame: 48 hours after initial treatment
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours
9 secondary outcomes
Change in Organ Failure
Time frame: Daily during ICU stay from the start of the initial treatment until day 4
All-cause mortality
Time frame: 28 days
Organ dysfunction-free days
Time frame: Daily during ICU stay (up to 28 days)
Intensive Care Unit (ICU) complications
Time frame: Daily during ICU stay (up to 28 days)
Ventilator-free days (VFDs)
Time frame: Daily during ICU stay (up to 28 days)
Length of stay (LOS) at ICU and hospital ward
Time frame: During ICU and hospital ward stay (up to 28 days)
Prognosis Factors
Time frame: From baseline up to 48 hours
Recurrence of sepsis
Time frame: 7 days
Persistence of sepsis
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. The Sponsor will be responsible for determining whether to register the clinical investigation on www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of Medical Journal Editors guidelines, or any other applicable guidelines.
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.
Herwig Gerlach, Prof. principal investigator
Vivantes Neukoelln Berlin
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seraph 100 in people with COVID-19, run by ExThera Medical Corporation at 5 sites in 2 countries.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Organ failure (time frame: 48 hours after initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.