Last updated 59 days ago
Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)
100 patients around the world
Available in Mexico
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).
ExThera Medical Corporation
1Research sites
100Patients around the world
This study is for people with
Covid-19
Long Covid
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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.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.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.
- 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.Unable to obtain informed consent from either patient or legally authorized representative.Any subject who, in the investigator's judgment, is considered unsuitable for participation in this trial.The patient must be able to perform a hemoperfusion procedure with an apheresis machine.
Sites
Hospital Ángeles Tijuana
SponsorExThera Medical Corporation
Conditions
Long Covid
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06637800
