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

Sponsor
Hellenic Institute for the Study of Sepsis
Study ID
NCT04339712
Phase
PHASE2
Status
Completed

Conditions

  • COVID-19
  • Corona Virus Infection
  • Macrophage Activation Syndrome
  • Virus Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anakinra — DRUG
    In case of diagnosis of MAS treatment with anakinra
  • Tocilizumab — DRUG
    In case of diagnosis of immune dysregulation treatment with tocilizumab

Study Details

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.

Key Dates

Start date
Apr 2, 2020
Status verified
Jan 2021
Primary completion
Dec 1, 2020
Completion
Jan 8, 2021

Study Design

Enrollment
102 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: anakinra
    In case of diagnosis of MAS, IV anakinra 200mg three times daily (every eight hours) for 7 days. Patients who will receive anakinra treatment and who suffer from kidney dysfunction will receive 50% of the dose i.e. 100mg anakinra three times daily for 15 days
  • Experimental: tocilizumab
    In case of diagnosis of immune dysregulation IV tocilizumab 8mg/kg body weight once up to a maximum of 800mg. These patients will receive anakinra at the above dose in case they meet one of the following contra-indications for tocilizumab: 1. absolute neutrophil count less than 2,500/mm3; 2. absolute platelet count less than 100,000/mm3; and 3. AST or ALT more than 1.5 x the upper normal limit

Primary Outcome Measure

Change of baseline total sequential organ failure assessment (SOFA) score [ Time Frame: Visit study day 8 ]

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