drugset / Trial / NCT04560205

Tocilizumab in COVID-19 Lahore General Hospital

NCT04560205

Phase 1 Unknown 50 enrolled Lahore General Hospital
NaSingle-groupOpen-labelTreatment

Summary

The most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.

Timeline

Start
2020-05-01
Primary completion
2020-12-30
Completion
2020-12-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 4 mg/kg Intravenous
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications