Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)

NCT06637800 | Withdrawn DMC FDA Device

• 1 other identifier: SLC01 Prolonged COVID
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (2)

• Assessment of Technical Procedure Success

  Procedural Success is defined as: 1. Device use as originally intended, and 2. No device procedure related serious adverse events (SAEs)

  Procedure Stop Time

• Assessment of Device Success

  Seraph 100 Device Success

  3, 7 and 28 days

Study Arms (1)

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.

Device: Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100)

Interventions

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.

Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ExThera Medical Corporation: lead

Study Sites (1)

Hospital Angeles Tijuana

Tijuana, Mexico

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mink Chawla, M.D.

  ExThera Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: February 15, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)