Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)
Key facts
- Who runs it
- ExThera Medical Corporation
- Where
- Mexico1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 15 Feb 2025
- Ended
- Apr 2025
- Type of study
- Interventional
- Treatments tested
- Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)
- Record updated
- 20 April 2026
- Why it stopped
- ExThera was not the sponsor. No patients were enrolled.
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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 take part
- The patient is currently enrolled in another drug or device trial. Patients who cannot tolerate placement of double-lumen catheter
- History of heparin allergy
- History of heparin-induced thrombocytopenia
- Subjects meeting any of the following criteria will not be recruited for the study:
- Pregnancy or breastfeeding
- Life expectancy is less than 30 days
- 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:
- The patient must be able to perform a hemoperfusion procedure with an apheresis machine
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single useTreatment being tested
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.
Treatment: Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 20 April 2026