Clinical trial NCT04547257: Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19
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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: ExThera Medical Europe BV
Sponsor class: INDUSTRY
Collaborators: name: ExThera Medical Corporation
name: Vivantes Clinic Neukölln
First posted: 2020-09-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Organ failure
timeFrame: 48 hours after initial treatment
Secondary outcomes:
measure: Change in Organ Failure
timeFrame: Daily during ICU stay from the start of the initial treatment until day 4
measure: All-cause mortality
timeFrame: 28 days
measure: Organ dysfunction-free days
timeFrame: Daily during ICU stay (up to 28 days)
measure: Intensive Care Unit (ICU) complications
timeFrame: Daily during ICU stay (up to 28 days)
measure: Ventilator-free days (VFDs)
timeFrame: Daily during ICU stay (up to 28 days)
measure: Length of stay (LOS) at ICU and hospital ward
timeFrame: During ICU and hospital ward stay (up to 28 days)
measure: Prognosis Factors
timeFrame: From baseline up to 48 hours
measure: Recurrence of sepsis
timeFrame: 7 days
measure: Persistence of sepsis
timeFrame: 7 days
Other outcomes:
measure: N (%) of patients with treatment emergent adverse events
timeFrame: Occurrence within the 28 days follow-up period
measure: Laboratory data
timeFrame: Daily during ICU stay (up to 28 days)
measure: Vital signs score
timeFrame: Daily during ICU stay (up to 28 days)
measure: Physical examination score
timeFrame: Daily during ICU stay (up to 28 days)
measure: Reduction of viral load
timeFrame: During treatment (minimum treatment duration is 5 hours, maximum treatment duration is 24 hours)
Locations:
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Vivantes Neukoelln Berlin
name: Herwig Gerlach, Prof.
role: PRINCIPAL_INVESTIGATOR
References: