This study will use a prospective, open, single-arm design, in which a group of 100patients with a diagnosis of prolonged COVID, previously selected according to inclusionand exclusion criteria, and who have undergone informed consent process and have signedthe informed consent form, undergo two hemoperfusion procedures with the Seraph 100filter, on consecutive days. They are then evaluated at day 3 and 4 weeks, to completethe 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).
Device: 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.
Inclusion Criteria:
Subjects will be considered eligible for participation in the study if they meet all the
following inclusion criteria:
1. Adult patients age of 18-85 (had 18th birthday but did not have 85th birthday).
2. 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).
3. 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).
4. Patient (legally designated representative) has completed the Informed Consent
process prior to enrollment into this study.
5. Patient (legally designated representative) is willing to comply with the study
protocol -
Exclusion Criteria:
Subjects meeting any of the following criteria will not be recruited for the study:
1. History of heparin allergy.
2. History of heparin-induced thrombocytopenia.
3. Pregnancy or breastfeeding.
4. Life expectancy is less than 30 days.
5. The patient is currently enrolled in another drug or device trial. Patients who
cannot tolerate placement of double-lumen catheter.
6. 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.
Hospital Angeles Tijuana
Tijuana, Mexico
Investigator: Brittany Ptak
brittany@lumati.com
Mink Chawla, M.D.
(925) 839-2060
mink@extheramedical.com
Drina Aldana
(925) 839-2060
Drina@extheramedical.com
Mink Chawla, M.D., Principal Investigator
ExThera Medical Corporation