Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction
NCT04339712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2021-01-11
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.
Conditions
- COVID-19
- Virus Diseases
- Macrophage Activation Syndrome
- Corona Virus Infection
Interventions
- DRUG
-
Anakinra
In case of diagnosis of MAS treatment with anakinra
- DRUG
-
In case of diagnosis of immune dysregulation treatment with tocilizumab
Sponsors & Collaborators
-
Hellenic Institute for the Study of Sepsis
lead OTHER
Principal Investigators
-
Apostolos Armaganidis, MD, PhD · National Kapodistrian University of Athens, Medical School
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-02
- Primary Completion
- 2020-12-01
- Completion
- 2021-01-08
Countries
- Greece
Study Locations
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