COVID-19 Clinical Trial
— ESCAPEOfficial title:
Efficiency in Management of Organ Dysfunction Associated With Infection by the Novel SARS-CoV-2 Virus (COVID-19) Through a Personalized Immunotherapy Approach: the ESCAPE Clinical Trial
Verified date | January 2021 |
Source | Hellenic Institute for the Study of Sepsis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.
Status | Completed |
Enrollment | 102 |
Est. completion date | January 8, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age equal to or above 18 years - Male or female gender - In case of women, unwillingness to remain pregnant during the study period. - Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent - Confirmed infection by SARS-CoV-2 virus using molecular techniques as defined by the World Health Organization11 - Organ dysfunction defined as the presence of at least one of the following conditions: - Total SOFA score greater than or equal to 2; - Involvement of the lower respiratory tract - Laboratory documentation of MAS or immune dysregulation. MAS is documented by the findings of any serum ferritin greater than 4,420ng/ml. immune dysregulation is documented by the combination of two findings: a) serum ferritin equal to or lower than 4,420ng/ml; and b) less than 5,000 receptors of the membrane molecule of HLA-DR on the cell membrane of blood CD14-monocytes or less than 30 MFI of HLA-DR on the cell membrane of blood CD14-monocytes as counted by flow cytometry Exclusion Criteria: - Age below 18 years - Denial for written informed consent - Any stage IV malignancy - Any do not resuscitate decision - Active tuberculosis (TB) as defined by the co-administration of drugs for the treatment of TB - Infection by the human immunodeficiency virus (HIV) - Any primary immunodeficiency - Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone or greater the last 15 days. - Any anti-cytokine biological treatment the last one month - Medical history of systemic lupus erythematosus - Medical history of multiple sclerosis or any other demyelinating disorder. - Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study |
Country | Name | City | State |
---|---|---|---|
Greece | 1st Department of Pulmonary Medicine and Intensive Care Unit | Athens | |
Greece | 2nd Department of Critical Care Medicine, ATTIKON University Hospital | Athens | Haidari |
Greece | 4th Department of Internal Medicine, Attikon University Hospital | Athens | |
Greece | Department of Internal Medicine, I PAMMAKARISTOS Hospital | Athens | |
Greece | Intensive Care Unit, General Hospital ASKLEPIEIO Voulas | Athens | |
Greece | Intensive Care Unit, General Hospital of Athens IPPOKRATEIO | Athens | |
Greece | Intensive Care Unit, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S. | Athens | |
Greece | Intensive Care Unit, "Latsio", Thriasio Elefsis General Hospital | Elefsína | |
Greece | Intensive Care Unit, Ioannina University Hospital | Ioánnina | Ioannina |
Greece | Department of Internal Medicine, Larissa University Hospital | Larissa | |
Greece | Intensive Care Unit, "Koutlimbaneio & Triantafylleio" Larissa General Hospital | Larissa | |
Greece | Department of Internal Medicine, Patras University Hospital | Patras | Rion |
Greece | Department of Anesthesiology and Intensive Care Medicine, University General Hospital of Thessaloniki AHEPA | Thessaloniki | |
Greece | Intensive Care Unit, AGIOS DIMITRIOS General Hospital of Thessaloniki | Thessaloniki | |
Greece | Intensive Care Unit, G. GENNIMATAS General Hospital of Thessaloniki | Thessaloniki | |
Greece | Intensive Care Unit, General Hospital of Thessaloniki IPPOKRATEIO | Thessaloniki | |
Greece | Intensive Care Unit, Theageneio Oncological Hospital of Thessaloniki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Institute for the Study of Sepsis |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of baseline total sequential organ failure assessment (SOFA) score | At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8 | Visit study day 8 | |
Primary | Improvement of lung involvement measurements | Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8 | Visit study day 8 | |
Primary | Increase of pO2/FiO2 ratio | At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8 | Visit Study Day 8 | |
Secondary | Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators | Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome) | Screening, Day 8 | |
Secondary | Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators | Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database | Screening, Day 8 | |
Secondary | Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators | Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database | Screening, Day 8 | |
Secondary | Change of sequential organ failure assessment (SOFA) score | Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome) | Day 28 | |
Secondary | Rate of Mortality | Mortality on day 28 | Day 28 | |
Secondary | Rate of Mortality | Mortality on day 90 | Day 90 | |
Secondary | Cytokine stimulation | Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4 | Screening, Day 4 | |
Secondary | Gene expression | Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4 | Screening, Day 4 | |
Secondary | Serum/plasma proteins | Change of serum/plasma proteins between days 0 and 4 | Screening, Day 4 | |
Secondary | Classification of the immune function | Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation | Screening |
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