Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction (NCT04339712) | Clinical Trial Compass
CompletedPhase 2
Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction
Greece102 participantsStarted 2020-04-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 la…
What they're measuring
1
Change of baseline total sequential organ failure assessment (SOFA) score