Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis

NCT05647096 | Not Yet Recruiting DMC

• 1 other identifier: SAN/01/2022
• Study Type: interventional
• Target: 73
• Locations: 3 countries
• Sites: 9

Brief Summary

This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in sepsis patients.

Conditions

Sepsis; Respiratory Failure

Keywords

Sepsis; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• To demonstrate the NucleoCapture column reduces the amount of cfDNA/NETs in the plasma of participants with sepsis and respiratory failure

  The mean reduction of an expected ≥50% of the net amount of cfDNA/NETs across the NucleoCapture column at the end of each NuceoCapture treatment session

  Within 6 hours from the baseline (pre-column) plasma

Secondary Outcomes (2)

• Mean reduction in circulating cfDNA/NETs measured by circulating blood levels of nucleosomes (H.3.1)

  Before and after treatment with the NucleoCapture column and at the start and end of a 6 hour period in the SOC treatment arm

• The clinical benefit of the NucleoCapture column in participants with sepsis and respiratory failure

  From date of randomisation to day 21 for organ support and day 28 for survival

Other Outcomes (3)

• The biological efficacy and performance of NucleoCapture will be assessed using routine biomarkers

  At baseline, days 1 to 5, day 7 and day 14

• The biological efficacy and performance of NucleoCapture will be assessed using non-routine biomarkers

  At baseline, days 1 to 5, day 7 and day 14

• Device handling and usability

  Day 1 up to day 5

Study Arms (2)

NucleoCapture Treatment

EXPERIMENTAL

Participants in the NucleoCapture treatment arm will receive Standard of Care plus three treatment sessions with the NucleoCapture treatment device. The device consists of 100ml NucleoCapture selective adsorber.

Device: NucleoCapture device

Standard of Care

NO INTERVENTION

Participants in the Standard of Care arm will receive standard medical care alone.

Interventions

NucleoCapture device DEVICE

100ml NucleoCapture selective DNA adsorber

NucleoCapture Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-75
• Proven or suspected respiratory sepsis aetiology
• Acute respiratory failure currently requiring invasive mechanical ventilation for not more than 48 hours duration
• Horowitz Index for Lung Function (Pa02/Fi02 Ratio) ≤200mmHg or ≤26.6kPa
• Sequential organ failure assessment score (SOFA) ≥4 and ≤ 14
• Have provided written informed consent or consent is given by the patient's legally designated representative or an independent physician (if possible, according to local law).

You may not qualify if:

• Expected duration of invasive mechanical ventilation less than 48 hours
• The use of other non-routine extracorporeal sepsis treatments such as very high flux renal replacement therapy (\>60ml/kg/h total exchange), use of high cut off filters or other non-routine extracorporeal treatment columns such as Cytosorb, Toramyxcin, etc).
• Presence of severe multiple organ failure at the point of enrolment as evidenced by:
• Severe refractory vasoplegic failure
• Norepinephrine dose \> 0.60 μg/kg/min
• Use of epinephrine
• Concomitant cardiogenic shock, clinically suspected or CI\<2.2 if measured
• Use of dobutamine, epinephrine, phosphodiesterase inhibitors or levosimendan
• Coagulopathy as defined by platelet count \<50
• Calculated Plasma Volume greater than 5000ml as determined by an estimation of total blood volume (according to Nadler's formula, incorporating height, weight and sex) multiplied by (1- Haematocrit). A total blood volume calculator is available at https://www.omnicalculator.com/health/blood-volume
• Long term oxygen therapy or home oxygen use
• Liver cirrhosis (histologically proven or clinically suspected)
• Active bleeding
• Citrate intolerance if citrate is required for therapeutic apheresis
• Heparin allergy if heparin is required for therapeutic apheresis

Sponsors & Collaborators

• Santersus AG: lead
• ISS AG: collaborator

Study Sites (9)

University of Bonn

Bonn, Germany

Location

Technical University Dresden

Dresden, Germany

Location

Hannover Medical School

Hannover, Germany

Location

University of Zurich

Zurich, Switzerland

Location

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Liverpool University Hospital

Liverpool, United Kingdom

Location

Guy's and St Thomas' Hospital

London, United Kingdom

Location

University College London

London, United Kingdom

Location

MeSH Terms

Conditions

Sepsis; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Andrew Aswani

  Santersus AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Barsoum

CONTACT

+447806820434; eb@santersus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either the interventional treatment arm (SOC plus NucleoCapture) or the SOC treatment arm in a 2:1

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 28, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (5); CH (1)