Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction

• Status: Completed
• Trial end date: 2021-01-08
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

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