Data Analysis of the Cytokine Adsorption Treatment on Coronavirus Disease-19 (COVID-19) Patients With Respiratory Failure

NCT04422626 | Withdrawn DMC

• 1 other identifier: 20802-5/2020/EÜIG
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe sepsis and septic shock are some of the leading causes of mortality in intensive care unit (ICU) admitted COVID-19 patients. The main cause of early mortality is the uncontrolled release of inflammatory mediators leading to cardiovascular failure. CytoSorb, a recently developed, highly biocompatible hemadsorption device has been tested, which can selectively remove inflammatory mediators from the circulation. This device is currently commercially available, and in Europe, it has been approved for clinical use. Based on experience to date, this adsorption technique may influence the immune function; removing inflammatory mediators from the blood may improve organ functions and even increase the chances of survival. CYTOAID is an observational, non-interventional study to assess the effectiveness of early cytokine adsorption therapy in critically ill patients who have been admitted to the ICU because of COVID-19 infection. Data on the applied therapy on COVID-19 patients in ICU will be collected and analyzed. The patient's examination and therapy will be applied according to the current regulations at the clinics and the current professional standards. The study does not require any additional examination or intervention.

Conditions

SARS-CoV-2; COVID-19

Keywords

CytoSorb; COVID-19; acute respiratory failure; cytokine; Intensive care unit; Sars-CoV-2

Outcome Measures

Primary Outcomes (1)

• Change in the partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy

  Change in the PaO2/FiO2 ratio after CytoSorb therapy as compared to baseline

  24 months

Secondary Outcomes (12)

• Change in inflammatory biomarker levels during treatment

  24 months

• change in organ function

  24 months

• length of stay in ICU

  24 months

• length of hospital stay

  24 months

• Duration of mechanical ventilation

  24 months

Study Arms (1)

Critically ill COVID-19 patients, who receive CytoSorb therapy

Patients in ICU due to critical COVID-19 infection, who receive early (within the first 24 hours, but no later than 48 hours after intubation) CytoSorb therapy on consultant's discretion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients admitted to ICUs requiring mechanical ventilation with proven COVID-19 infection and treated with CytoSorb.

You may qualify if:

• Age \>18 years
• confirmed COVID-19 infection
• ICU admission
• Mechanical ventilation due to COVID-19 pulmonary complications
• Moderate to severe acute respiratory distress syndrome (ARDS)
• CytoSorb therapy indicated by the attending medical team preferably within the first 24 hours, but no later than 48 hours after intubation
• Informed consent for data collection

You may not qualify if:

• Unlikely survival for 24 hours according to the attending physician
• Acute onset of hemato-oncological illness
• Patient already on ECMO
• Immunosuppression: on chronic systemic steroid therapy (\>10 mg prednisolon/day); immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)
• Patients with transplanted vital organs
• Thrombocytopenia (\<20,000/uL)

Sponsors & Collaborators

• University of Pecs: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Three tubes (less than 25 ml) of blood and 2 ml of saliva will be collected to detect different antibodies, just in case if the physician already ordered blood test. Additional puncture won't be carried out.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Péter Hegyi, MD, PhD, DSc

  Insitute for Translational Medicine, University of Pécs, HU

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 9, 2020
• Study Start: February 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share