Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection : A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

The limited understanding of the clinical behavior of patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (the viral organism responsible for COVID-19 disease) is evolving on a daily basis. Reports from China indicate that a subset of patients with the worst clinical outcomes may manifest cytokine storm syndrome. Hypotheses that excess cytokines may trigger a secondary hemophagocytic lymphohistiocytosis (sHLH) have been proposed. Indeed, cytokine profiles consistent with this picture were observed in Chinese patients with severe pulmonary involvement. Specifically, elevated ferritin and interleukin-6 (IL-6) were associated with fatalities among the infected patients. A role for targeted anti-inflammatory and anti-cytokine therapies in the treatment of pulmonary hyperinflammation has been proposed.Clazakizumab is a genetically engineered humanized immunoglobulin-1 (IgG1) monoclonal antibody (mAb) that binds with high affinity to human IL-6. This investigational agent is currently being studied as a treatment for chronic active antibody mediated rejection of renal allografts.In this study investigators propose to administer clazakizumab to patients with life-threatening pulmonary failure secondary to COVID-19 disease..

Medienart:

Klinische Studie

Erscheinungsjahr:

2022

Erschienen:

2022

Enthalten in:

ClinicalTrials.gov - (2022) vom: 08. Apr. Zur Gesamtaufnahme - year:2022

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
COVID-19
Medical Condition: COVID-19
Phase: Phase 2
Recruitment Status: Terminated
Study Type: Interventional

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: May 8, 2020, Last downloaded: ClinicalTrials.gov processed this data on April 18, 2022, Last updated: April 20, 2022

Study ID:

NCT04381052
AAAT0142

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG00338618X