Cellfree DNA as a prognostic biomarker in ICU patients suffering from COVID-19 or sepsis

Cellfree DNA as a prognostic biomarker in ICU patients suffering from COVID-19 or sepsis - COVSEP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025222

Enrollment

120

Registered

2021-04-30

Start date

2021-05-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, sepsis A41.9

Interventions

Group 1: ICU patients suffering from sepsis => Blood collection on three days, determination of the cfDNA level, pseudonymised recording of clinical data Group 2: ICU patients suffering from COVID-19

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who meet the following criteria will be included in this study: -Patients =18 years of age with one of the three following diagnoses: - Acute SARS-Cov-2 infection upon admission to the intensive care unit OR - Sepsis with no known previous SARS-CoV-2 infection

Exclusion criteria

Exclusion criteria: Patients who meet only one of the following criteria will not be included in this study: - Pregnant women - Breastfeeding women - Known, active tumor disease in treatment - Palliative therapy approach - Present DNR (Do Not Resuscitate) / DNI (Do Not Intubate) / DNARRT (Do Not Apply Renal Replacement Therapy) arrangement - Inclusion stop at escalation level 4 according to SOP of the COVID supply

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the overall survival of the patients in both groups (COVID-19 group, sepsis group) within the first 30 days after determining the first cfDNA value.	—

Secondary

Measure	Time frame
Secondary objectives are - Cf-DNA course in the following subgroups: COVID group, sepsis group, survivors, deceased. The course parameters to be examined are maximum, minimum, average, difference between maximum and minimum, falling or rising trend of the three recorded values. - Association of cf-DNA maximum and other course parameters with a) Risk factors (age, frailty, diabetes, obesity, hypertension, immunodeficiency) b) Organ failure (SOFA total and partial scores) c) Inflammation (white blood cell count, CRP, interleukin-6) d) Coagulopathy (D-dimers, platelet count) e) Complications (neurological, pulmonary, cardiac, renal) f) Outcome (ventilation-free days, ICU days, length of hospital stay) - Comparison of these associations between COVID and sepsis groups	—

Measure

Time frame

Secondary objectives are - Cf-DNA course in the following subgroups: COVID group, sepsis group, survivors, deceased. The course parameters to be examined are maximum, minimum, average, difference between maximum and minimum, falling or rising trend of the three recorded values. - Association of cf-DNA maximum and other course parameters with a) Risk factors (age, frailty, diabetes, obesity, hypertension, immunodeficiency) b) Organ failure (SOFA total and partial scores) c) Inflammation (white blood cell count, CRP, interleukin-6) d) Coagulopathy (D-dimers, platelet count) e) Complications (neurological, pulmonary, cardiac, renal) f) Outcome (ventilation-free days, ICU days, length of hospital stay) - Comparison of these associations between COVID and sepsis groups

—

Countries

Germany

Contacts

Public ContactMarc Bodenstein

Klinik für Anästhesiologie der Universitätsmedizin Mainz

marc.bodenstein@unimedizin-mainz.de+496131177168

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026