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ExThera was not the sponsor. No patients were enrolled.
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Technical Procedure Success | Procedural Success is defined as:
| Procedure Stop Time |
| Assessment of Device Success | Seraph 100 Device Success | 3, 7 and 28 days |
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Inclusion Criteria:
Subjects will be considered eligible for participation in the study if they meet all the following inclusion criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will not be recruited for the study:
After verification of eligibility and signature of consent:
1. The patient must be able to perform a hemoperfusion procedure with an apheresis machine.
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| Name | Affiliation | Role |
|---|---|---|
| Mink Chawla, M.D. | ExThera Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Angeles Tijuana | Tijuana | Mexico |
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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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Unblinded
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|
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |