Status:
COMPLETED
Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
COVID-19
Virus Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Humanity is experiencing since November 2019 a new pandemic by the novel SARS Coronavirus-19 (SARS-CoV-2). As of March 16 2020 170,191 documented case were reported worldwide of which 6,526 died1. The...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04339712
Start Date
April 2 2020
End Date
January 8 2021
Last Update
January 11 2021
Active Locations (17)
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1
2nd Department of Critical Care Medicine, ATTIKON University Hospital
Athens, Haidari, Greece, 12462
2
Intensive Care Unit, Ioannina University Hospital
Ioannina, Ioannina, Greece, 45500
3
Department of Internal Medicine, Patras University Hospital
Pátrai, Rion, Greece, 26504
4
Department of Internal Medicine, I PAMMAKARISTOS Hospital
Athens, Greece, 11144