COVID-19 Acute Respiratory Distress SyndromeHERICCNCT05470907
Registry for Hemoperfusion of Covid-19 ICU Patients
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Viral Disease, run by Croatian Society for Organ Support at 1 site in Croatia.
Trial summary
The ongoing COVID-19 pandemic caused high hospitalization and mortality rates especially in critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Viral Disease, Critical Illness
- What is being tested?
- Hemoperfusion
- Type of treatment
- Medical device
- How many people
- 1,050 participants
- Where
- 1 siteCroatia
- Study dates
- 21 Jul 2022to 5 Feb 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All medical institutions from South-East European countries (Slovenia, Croatia, Bosnia, Montenegro, Serbia, Macedonia, Albania, Kosovo, Greece, Italy, Turkey, Bulgaria and Romania) that provide extracorporeal blood purification treatments to COVID-19 critically ill patients are eligible for participation.
Who may be able to join
- COVID-19 infection
- laboratory and clinical evidence of systemic inflammation: high levels of inflammatory cytokines such as IL-6 (>25 pg / ml); high values of inflammatory parameters from serum (leukocytes >15x10 9 / l, CRP >40 mg / l, procalcitonin >0.9 mg / l) and a high SOFA score (>2).
- diagnosed with sepsis or septic shock: sepsis is defined as the presence of suspected or documented infections along with systemic inflammatory response syndrome; septic shock is defined as the presence of sepsis and acute circulatory failure according to European criteria Society for Intensive Care Medicine
- clinical symptoms of hemodynamic instability requiring vasopressors and initial signs immune dysregulation or cascade coagulation disorders
- acute kidney injury assessed according to KDIGO / AKIN criteria: increase in serum creatinine ≥ 0.3 mg / dL within 48 hours, or ≥ 50% over 7 days, or hourly diuresis <0.5 mL / kg / h for more than 6 hours
- diagnosis of ARDS
Show all 9Show fewer
- the need for ECMO
- deterioration of respiratory status with the onset of respiratory failure requiring mechanical ventilation (respiration rate >30 / min, or oxygen saturation <93%, or PaO2 / FiO2 ratio <300mmHg).
- Admission to ICU
Who cannot join
- besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients
The ongoing COVID-19 pandemic caused high hospitalization and mortality rates especially in critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. The purpose of this registry study is to investigate the effectiveness and safety of the extracorporeal blood purification and hemoperfusion/hemadsorption filters in treating of critically ill COVID-19 patients.
Read the detailed description
The COVID-19 pandemic has been associated with high mortality rate and high percentage of patients with with severe multi-organ dysfunction. Many therapies were investigated in this group of patients. The usage of extracorporeal blood purification, namely hemoperfusion/hemadsorption was introduced in everyday clinical practice even before COVID-19 pandemic in which became increasingly common. The efficacy of hemoperfusion/hemadsorption in removal of endotoxins and cytokines is still questioned by some physicians mostly due to the fact that some trials failed to demonstrate the effect of this therapy on long-term outcomes of critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. Several extracorporeal blood purification therapies have been proposed to attenuate systemic inflammation in COVID-19 patients but there is no study which analyzed more than one filter or patients without specific conditions. Due to these limitations the studies were not able to analyze the method itself. Therefore, the primary aim of this observational prospective, multi-centric, regional web-based registry is to define the results and outcome of treatment, possible advantages over patients who have not undergone targeted treatment and to set regional indications/inclusion criteria for the treatment of ICU COVID-19 patients with the method of hemoadsorption/hemoperfusion.
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome, Viral Disease, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome, AKI - Acute Kidney Injury
- Being tested
- Hemoperfusion
- Keywords
- COVID-19 Acute Respiratory Distress Syndrome, Viral Disease, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome, AKI - Acute Kidney Injury
- Medical subject headings
- Virus Diseases, Critical Illness, Multiple Organ Failure, Systemic Inflammatory Response Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoperfusionDevice
Commercial membranes for extracorporeal blood purification (hemoperfusion)
| Study group | Role | What they receive |
|---|---|---|
| EBP | ICU COVID-19 patients treated with hemoperfusion/hemadsorption Receives: Device: Hemoperfusion | |
| non-EBP | ICU COVID-19 patients not treated with hemoperfusion/hemadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients
Define the inclusion criteria for extracorporeal blood purification (hemoperfusion) with different filters/hemadsorbers in ICU COVID-19 patients
Measured: 28 days
Secondary outcomes (9)
To assess the correlation between hemoperfusion and positive short-term outcome
Define as to assess the correlation between hemoperfusion and positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 24 hours after hemoperfusion initiation
To assess the correlation between hemoperfusion and positive short-term outcome
Define as to assess the correlation between hemoperfusion and positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 72 hours after finishing all the hemoperfusion procedures
To assess the correlation between hemoperfusion and positive long-term outcome
To assess the correlation between hemoperfusion and positive long-term outcome, defined as patient survival at ICU discharge.
Measured: 28 days
To assess the correlation between different filters/hemadsorbers and positive short-term outcome
Define as to assess the correlation between different filters/hemadsorbers and positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 24 hours after hemoperfusion initiation
To assess the correlation between different filters/hemadsorbers and positive short-term outcome
Define as to assess the correlation between different filters/hemadsorbers and positive long-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 72 hours after finishing all the hemoperfusion procedures
To assess the correlation between different filters/hemadsorbers and positive long-term outcome
To assess the correlation between different filters/hemadsorbers and positive long-term outcome, defined as patient survival at ICU discharge.
Measured: 28 days
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 24 hours after initiation of the procedure with the combination of filters/hemadsorbers and extracorporeal organ support therapy
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 72 hours after finishing all the procedures with the combination of filters/hemadsorbers and extracorporeal organ support therapy
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start21 Jul 2022
- Primary completion1 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Croatian Society for Organ Support
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Responsible party
- Principal investigator, Vedran Premuzic, Croatian Society for Organ Support
- Investigators
- Vedran Premuzic, M.D., Ph.D., Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470907
- Sponsor's protocol ID
- HERICC-1982
- Acronym
- HERICC
- Status last verified
- Feb 2025
- First submitted
- 21 Jul 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lovric D, Situm I, Nedeljkovic V, Mogus M, Erceg A, Mazar M, Mihaljevic S, Premuzic V. Seraph(R) filter effectiveness in the treatment of circuit-related infections in ECMO patients-a single-center report. Front Med (Lausanne). 2025 Oct 17;12:1664552. doi: 10.3389/fmed.2025.1664552. eCollection 2025.
PubMed 41179859
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients
- ClinicalTrials.gov ID
- NCT05470907
- Acronym / sponsor ID
- HERICC / HERICC-1982
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome, Viral Disease, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome, AKI - Acute Kidney Injury
- Keywords
- COVID-19 Acute Respiratory Distress Syndrome, Viral Disease, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome, AKI - Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Croatian Society for Organ SupportUniversity, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ongoing COVID-19 pandemic caused high hospitalization and mortality rates especially in critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. The purpose of this registry study is to investigate the effectiveness and safety of the extracorporeal blood purification and hemoperfusion/hemadsorption filters in treating of critically ill COVID-19 patients.
Detailed description
The COVID-19 pandemic has been associated with high mortality rate and high percentage of patients with with severe multi-organ dysfunction. Many therapies were investigated in this group of patients. The usage of extracorporeal blood purification, namely hemoperfusion/hemadsorption was introduced in everyday clinical practice even before COVID-19 pandemic in which became increasingly common. The efficacy of hemoperfusion/hemadsorption in removal of endotoxins and cytokines is still questioned by some physicians mostly due to the fact that some trials failed to demonstrate the effect of this therapy on long-term outcomes of critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. Several extracorporeal blood purification therapies have been proposed to attenuate systemic inflammation in COVID-19 patients but there is no study which analyzed more than one filter or patients without specific conditions. Due to these limitations the studies were not able to analyze the method itself. Therefore, the primary aim of this observational prospective, multi-centric, regional web-based registry is to define the results and outcome of treatment, possible advantages over patients who have not undergone targeted treatment and to set regional indications/inclusion criteria for the treatment of ICU COVID-19 patients with the method of hemoadsorption/hemoperfusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBP | – | Device: HemoperfusionICU COVID-19 patients treated with hemoperfusion/hemadsorption |
| non-EBP | – | –ICU COVID-19 patients not treated with hemoperfusion/hemadsorption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All medical institutions from South-East European countries (Slovenia, Croatia, Bosnia, Montenegro, Serbia, Macedonia, Albania, Kosovo, Greece, Italy, Turkey, Bulgaria and Romania) that provide extracorporeal blood purification treatments to COVID-19 critically ill patients are eligible for participation.
Key inclusion criteria (9 listed)
- COVID-19 infection
- laboratory and clinical evidence of systemic inflammation: high levels of inflammatory cytokines such as IL-6 (>25 pg / ml); high values of inflammatory parameters from serum (leukocytes >15x10 9 / l, CRP >40 mg / l, procalcitonin >0.9 mg / l) and a high SOFA score (>2).
- diagnosed with sepsis or septic shock: sepsis is defined as the presence of suspected or documented infections along with systemic inflammatory response syndrome; septic shock is defined as the presence of sepsis and acute circulatory failure according to European criteria Society for Intensive Care Medicine
- clinical symptoms of hemodynamic instability requiring vasopressors and initial signs immune dysregulation or cascade coagulation disorders
- acute kidney injury assessed according to KDIGO / AKIN criteria: increase in serum creatinine ≥ 0.3 mg / dL within 48 hours, or ≥ 50% over 7 days, or hourly diuresis <0.5 mL / kg / h for more than 6 hours
Key exclusion criteria (1 listed)
- besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoperfusionCommercial membranes for extracorporeal blood purification (hemoperfusion) | Device | EBP |
Primary outcome
Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients
Time frame: 28 days
Define the inclusion criteria for extracorporeal blood purification (hemoperfusion) with different filters/hemadsorbers in ICU COVID-19 patients
9 secondary outcomes
To assess the correlation between hemoperfusion and positive short-term outcome
Time frame: 24 hours after hemoperfusion initiation
To assess the correlation between hemoperfusion and positive short-term outcome
Time frame: 72 hours after finishing all the hemoperfusion procedures
To assess the correlation between hemoperfusion and positive long-term outcome
Time frame: 28 days
To assess the correlation between different filters/hemadsorbers and positive short-term outcome
Time frame: 24 hours after hemoperfusion initiation
To assess the correlation between different filters/hemadsorbers and positive short-term outcome
Time frame: 72 hours after finishing all the hemoperfusion procedures
To assess the correlation between different filters/hemadsorbers and positive long-term outcome
Time frame: 28 days
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
Time frame: 24 hours after initiation of the procedure with the combination of filters/hemadsorbers and extracorporeal organ support therapy
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
Time frame: 72 hours after finishing all the procedures with the combination of filters/hemadsorbers and extracorporeal organ support therapy
The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 41179859Lovric D, Situm I, Nedeljkovic V, Mogus M, Erceg A, Mazar M, Mihaljevic S, Premuzic V. Seraph(R) filter effectiveness in the treatment of circuit-related infections in ECMO patients-a single-center report. Front Med (Lausanne). 2025 Oct 17;12:1664552. doi: 10.3389/fmed.2025.1664552. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vedran Premuzic, M.D., Ph.D. principal investigator
Clinical Hospital Centre Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Viral Disease, run by Croatian Society for Organ Support at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.