Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637800
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Prospective Open-label Study of Seraph 100 in Patients With Prolonged COVID PC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Open-label Study of Seraph 100 in Patients With Prolonged COVID PC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None