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

No results posted yet for this study

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

Tocilizumab

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04339712 on ClinicalTrials.gov