Tocilizumab in COVID-19 Lahore General Hospital
Tocilizumab in COVID-19 Lahore General Hospital
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.
This is intervention single-center study, that will be done at Lahore General Hospital in
 which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval
 will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed
 consent will be obtained from all patients who will agree to publish their data in this
 research. Patient's privacy and obey will be protected with the Helsinki Declaration.
Inclusion Criteria:

 -  All patients of all ages, males and non-pregnant females who will be diagnosed
 COVID-19 positive by RT-PCR.

 -  Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT
 chest.

 -  Patient >55 years of age Or Age <55 with comorbid condition who will be unable to
 maintain O2 sat > 93% with 5-7 liter of oxygen.

 -  Or Patient < 55 with no comorbid conditions, who will be unable to maintain O2 sat >
 93% with 7-10 liter of oxygen.

 -  Respiratory rate > 30-35/ min and >50% of radiological involvement of lung with
 typical lesions.

 -  Along with > 50% deranged ≥ 2 biochemical markers CRP > 50 mg/l, LDH > 1000U/L,
 D.Dimer > 1mg/l or 1000 ng/ml, Serum Ferritin > 1000 ng/ml or mcg/l will be included
 in clinical trial.

 Exclusion Criteria:

 -  Patient who will not require supplemental oxygen during hospital stay.

 -  Patients on Invasive mechanical ventilation (IMV).

 -  Patients with respiratory rate < 30/mins and whose laboratory findings will not be
 deranged > 50%.

 -  Patients with improving radiological findings will be excluded.

 -  Patients suffering from Active TB

 -  Herpes zoster

 -  Multiple sclerosis,

 -  Allergic to tocilizumab

 -  Presences of chronic renal failure > 4 stage, GFR < 30ml/min/1.73m2.

 -  ALT/AST > 5 times than normal values.

 -  Presences of neutropenia < 500/mm3.

 -  Platelets count less than 50 ×103 /µl.

 -  Complicated diverticulitis/ intestinal perforation.

 -  Immune-suppressive anti- rejection therapy.

 -  Pregnant women.

 -  Previous MI/ IHD, IV heart failure.

 -  Psychiatric patients.