Long COVIDNCT06637800
Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)
A study testing Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in people with Long COVID, run by ExThera Medical Corporation at 1 site in Mexico.
Trial summary
This study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged COVID, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 15 Feb 2025to Apr 2025
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be considered eligible for participation in the study if they meet all the following inclusion criteria:
- Adult patients age of 18-85 (had 18th birthday but did not have 85th birthday).
- History of COVID 19 infection established by positive polymerase chain reaction (PCR) test or by compatible clinical testing (e.g. rapid antigen, serum testing, or other relevant clinical documentation).
- Persistent symptoms for 12 or more weeks after acute COVID 19 infection including fatigue and one or more of the following: myalgia or generalized aches and pains; joint pain; dizziness or unsteadiness; cognitive dysfunction (mental fog).
- Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.
- Patient (legally designated representative) is willing to comply with the study protocol -
Who cannot join
- Subjects meeting any of the following criteria will not be recruited for the study:
- History of heparin allergy.
- History of heparin-induced thrombocytopenia.
- Pregnancy or breastfeeding.
- Life expectancy is less than 30 days.
- The patient is currently enrolled in another drug or device trial. Patients who cannot tolerate placement of double-lumen catheter.
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- Unable to obtain informed consent from either patient or legally authorized representative (LAR)Any subject who, in the investigator's judgment, is considered unsuitable for participation in this trial.
- After verification of eligibility and signature of consent:
- 1. The patient must be able to perform a hemoperfusion procedure with an apheresis machine.
Trial locations and contacts
1 site in 1 country.
About this study
This study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged COVID, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion procedures with the Seraph 100 filter, on consecutive days. They are then evaluated at day 3 and 4 weeks, to complete the safety and effectiveness assessment.
Read the detailed description
This will be a prospective, open-label, single-arm, pilot study, in which a group of 100 PC patients will undergo two hemoperfusion procedures, to verify the safety and preliminary efficacy of the Seraph 100 device. Eligible patients will be invited to participate and once they sign the Informed Consent (IC) they will undergo two hemoperfusion procedures, on consecutive days, of -4 hours duration each time, using a multicomponent apheresis machine with the Seraph 100 filter. Patients will be followed for a total of 30 days, to monitor the presence of AEs (safety) and possible changes in clinical outcomes (preliminary efficacy).
- Conditions
- Long COVID
- Being tested
- Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)Device
The Seraph 100 is part of the Seraph platform technology that was developed as an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens, bacteria, viruses, fungus, and other sepsis mediators from the bloodstream. In addition, it has been demonstrated that Seraph 100 is also capable of removing circulating tumor cells from the whole blood.
| Study group | Role | What they receive |
|---|---|---|
| Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use | Experimental | The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use, disposable column packed with ultra-high molecular weight polyethylene (UHMWPE) beads. These beads have been modified to contain endpoint-attached heparin on the surface, thus forming a new chemical entity, the polymer now containing material of animal origin (porcine mucosa). The devices are sterilized using a standard ethylene oxide (EtO) cycle, following ISO 11135:2014. Receives: Device: Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Technical Procedure Success
Procedural Success is defined as:
- Device use as originally intended, and
- No device procedure related serious adverse events (SAEs)
Measured: Procedure Stop Time
Assessment of Device Success
Seraph 100 Device Success
Measured: 3, 7 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Feb 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: ExThera was not the sponsor. No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ExThera Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mink Chawla, M.D., Principal investigator, ExThera Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637800
- Sponsor's protocol ID
- SLC01 Prolonged COVID
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Following completion of the study, results of this research will be in a scientific journal. Data will be available immediately following publication, with no end date, with data sharing at the discretion of the Sponsor.
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
- Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)
- ClinicalTrials.gov ID
- NCT06637800
- Acronym / sponsor ID
- SLC01 Prolonged COVID
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ExThera was not the sponsor. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ExThera Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
This study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged COVID, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion procedures with the Seraph 100 filter, on consecutive days. They are then evaluated at day 3 and 4 weeks, to complete the safety and effectiveness assessment.
Detailed description
This will be a prospective, open-label, single-arm, pilot study, in which a group of 100 PC patients will undergo two hemoperfusion procedures, to verify the safety and preliminary efficacy of the Seraph 100 device. Eligible patients will be invited to participate and once they sign the Informed Consent (IC) they will undergo two hemoperfusion procedures, on consecutive days, of -4 hours duration each time, using a multicomponent apheresis machine with the Seraph 100 filter. Patients will be followed for a total of 30 days, to monitor the presence of AEs (safety) and possible changes in clinical outcomes (preliminary efficacy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use | Experimental | Device: Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use, disposable column packed with ultra-high molecular weight polyethylene (UHMWPE) beads. These beads have been modified to contain endpoint-attached heparin on the surface, thus forming a new chemical entity, the polymer now containing material of animal origin (porcine mucosa). The devices are sterilized using a standard ethylene oxide (EtO) cycle, following ISO 11135:2014. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be considered eligible for participation in the study if they meet all the following inclusion criteria:
- Adult patients age of 18-85 (had 18th birthday but did not have 85th birthday).
- History of COVID 19 infection established by positive polymerase chain reaction (PCR) test or by compatible clinical testing (e.g. rapid antigen, serum testing, or other relevant clinical documentation).
- Persistent symptoms for 12 or more weeks after acute COVID 19 infection including fatigue and one or more of the following: myalgia or generalized aches and pains; joint pain; dizziness or unsteadiness; cognitive dysfunction (mental fog).
- Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.
Key exclusion criteria (9 listed)
- History of heparin allergy.
- History of heparin-induced thrombocytopenia.
- Pregnancy or breastfeeding.
- Life expectancy is less than 30 days.
- The patient is currently enrolled in another drug or device trial. Patients who cannot tolerate placement of double-lumen catheter.
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 Filter (Seraph 100)The Seraph 100 is part of the Seraph platform technology that was developed as an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens, bacteria, viruses, fungus, and other sepsis mediators from the bloodstream. In addition, it has been demonstrated that Seraph 100 is also capable of removing circulating tumor cells from the whole blood. | Device | Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use |
Primary outcome
Assessment of Technical Procedure Success
Time frame: Procedure Stop Time
Procedural Success is defined as: 1. Device use as originally intended, and 2. No device procedure related serious adverse events (SAEs)
Assessment of Device Success
Time frame: 3, 7 and 28 days
Seraph 100 Device Success
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. Following completion of the study, results of this research will be in a scientific journal. Data will be available immediately following publication, with no end date, with data sharing at the discretion of the Sponsor.
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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.
Mink Chawla, M.D. principal investigator
ExThera Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in people with Long COVID, run by ExThera Medical Corporation at 1 site in Mexico.
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 6 inclusion and 9 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: withdrawn, 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 1 site in Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assessment of Technical Procedure Success (time frame: Procedure Stop Time). The study lists 2 primary outcomes in all. 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.