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Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19 (CP022)

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Seraph 100
Sponsored by
ExThera Medical Europe BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects with confirmed SARS-CoV-2 infection
  2. Be ≥ 18 years old and ≤90 years old
  3. Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points
  4. At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point
  5. Written or electronic consent of the subjects who are legally competent and have the capacity to give consent

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation
  2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
  4. Have Child-Pugh Class C cirrhosis
  5. Have platelet count <30.000/uL
  6. Contraindications for heparin sodium for injection
  7. Subjects demonstrating any contraindication for this treatment as described in the IFU
  8. Subjects with known allergy of polyethylene and copolyester
  9. Subjects with hospital-acquired SARS-CoV-2 infections
  10. Subject is held in an institution by court or official order
  11. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary

Sites / Locations

  • Klinikum Aschaffenburg-AlzenauRecruiting
  • Vivantes Klinikum Neukölln
  • Universitätsklinikum Essen
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Extracorporeal therapy with Seraph 100 blood filter

patients receive antibiotics only as standard of care

Outcomes

Primary Outcome Measures

Change in Organ failure
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours

Secondary Outcome Measures

Change in Organ Failure
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction)
All-cause mortality
All-cause mortality
Organ dysfunction-free days
Organ dysfunction-free days
Intensive Care Unit (ICU) complications
Intensive Care Unit (ICU) complications
Ventilator-free days (VFDs)
Ventilator-free days (VFDs)
Length of stay (LOS) at ICU and hospital ward
Length of stay (LOS) at ICU and hospital ward
Prognosis Factors
Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2)
Recurrence of sepsis
Recurrence of sepsis
Persistence of sepsis
Persistence of sepsis

Full Information

First Posted
April 29, 2020
Last Updated
December 15, 2021
Sponsor
ExThera Medical Europe BV
Collaborators
ExThera Medical Corporation, Vivantes Clinic Neukölln
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1. Study Identification

Unique Protocol Identification Number
NCT04547257
Brief Title
Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19
Acronym
CP022
Official Title
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ExThera Medical Europe BV
Collaborators
ExThera Medical Corporation, Vivantes Clinic Neukölln

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
Detailed Description
This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection. The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only). Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The primary objective is to demonstrate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the clinical improvement of SARS-CoV-2 infected patients, measured by the reduction of established and suspected prognostic parameters.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Extracorporeal therapy with Seraph 100 blood filter
Arm Title
Control
Arm Type
No Intervention
Arm Description
patients receive antibiotics only as standard of care
Intervention Type
Device
Intervention Name(s)
Seraph 100
Intervention Description
Bloodfiltration with Seraph 100
Primary Outcome Measure Information:
Title
Change in Organ failure
Description
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours
Time Frame
48 hours after initial treatment
Secondary Outcome Measure Information:
Title
Change in Organ Failure
Description
Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction)
Time Frame
Daily during ICU stay from the start of the initial treatment until day 4
Title
All-cause mortality
Description
All-cause mortality
Time Frame
28 days
Title
Organ dysfunction-free days
Description
Organ dysfunction-free days
Time Frame
Daily during ICU stay (up to 28 days)
Title
Intensive Care Unit (ICU) complications
Description
Intensive Care Unit (ICU) complications
Time Frame
Daily during ICU stay (up to 28 days)
Title
Ventilator-free days (VFDs)
Description
Ventilator-free days (VFDs)
Time Frame
Daily during ICU stay (up to 28 days)
Title
Length of stay (LOS) at ICU and hospital ward
Description
Length of stay (LOS) at ICU and hospital ward
Time Frame
During ICU and hospital ward stay (up to 28 days)
Title
Prognosis Factors
Description
Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2)
Time Frame
From baseline up to 48 hours
Title
Recurrence of sepsis
Description
Recurrence of sepsis
Time Frame
7 days
Title
Persistence of sepsis
Description
Persistence of sepsis
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
N (%) of patients with treatment emergent adverse events
Description
N (%) of patients with treatment emergent adverse events
Time Frame
Occurrence within the 28 days follow-up period
Title
Laboratory data
Description
Laboratory data (blood test, hematology, chemistry, coagulation, and blood gases)
Time Frame
Daily during ICU stay (up to 28 days)
Title
Vital signs score
Description
Vital signs score
Time Frame
Daily during ICU stay (up to 28 days)
Title
Physical examination score
Description
Physical examination score
Time Frame
Daily during ICU stay (up to 28 days)
Title
Reduction of viral load
Description
Reduction of viral load
Time Frame
During treatment (minimum treatment duration is 5 hours, maximum treatment duration is 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with confirmed SARS-CoV-2 infection Be ≥ 18 years old and ≤90 years old Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point Written or electronic consent of the subjects who are legally competent and have the capacity to give consent Exclusion Criteria: Subject is currently participating in another clinical investigation Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results Have Child-Pugh Class C cirrhosis Have platelet count <30.000/uL Contraindications for heparin sodium for injection Subjects demonstrating any contraindication for this treatment as described in the IFU Subjects with known allergy of polyethylene and copolyester Subjects with hospital-acquired SARS-CoV-2 infections Subject is held in an institution by court or official order Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Kikken-Jussen
Phone
+ 31 43 8200 399
Email
carla@extheramedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herwig Gerlach, Prof.
Organizational Affiliation
Vivantes Neukoelln Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Aschaffenburg-Alzenau
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Büttner, Dr.
Phone
+49 6021 320
Email
stefan.buettner@kgu.de
First Name & Middle Initial & Last Name & Degree
Stefan Büttner, Dr.
Facility Name
Vivantes Klinikum Neukölln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricard Ferrer Roca, Dr.
Phone
+34 93 489 44 20
Email
r.ferrer@vhebron.net
First Name & Middle Initial & Last Name & Degree
Ricard Ferrer Roca, Dr.
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Sponsor will be responsible for determining whether to register the clinical investigation on www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of Medical Journal Editors guidelines, or any other applicable guidelines.
IPD Sharing Time Frame
in 9 months
IPD Sharing URL
http://extheramedical.com

Learn more about this trial

Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19

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