Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia

Study Overview
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Brief Summary
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Tocilizumab (TCZ), interleukin-6 (IL-6), newly appeared as treatment of cytokine release syndrome (CRS) in patients with severe covid-19 associated pneumonia. In the present study, we aimed to discuss the treatment response of TCZ therapy in COVID-19 infected patients.

Detailed Description
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This observational study was designed just to visualize the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers.Patients will be followed until Day 29 after randomization.

Official Title
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Tocilizumab and Cytokine Release Syndrome (CRS) In Covid-19 Pneumonia: Experience From Single Center of Pakistan

Conditions
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Cytokine Release Syndrome, Covid-19 Pneumonia

Intervention / Treatment
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* Drug: Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old; Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending); Hospitalized with COVID-19-induced pneumonia; Elevated CRP, D-Dimers or ferritin levels; Bodyweight ≥ 40kg. Exclusion Criteria: Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab; Use of tocilizumab within 3 weeks prior; Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19); Patients with significant neutropenia (ANC <1000/mm3); Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to tocilizumab dose.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Group<br>All the patients suffering from severe covid pneumonia and laboratory parameter suggestive of cytokine release syndrome. | Drug: Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)<br>* Tocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS).<br>* Other names: Actemra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Patient admitted with cytokine release syndrome and given Tocilizumab and primary outcome was death within hospital. | 28 days | 
| Time to discharge | Time to Hospital Discharge or Ready for Discharge as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or >/= 2 liters (L) supplemental oxygen. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory parameters | All the specialized labs (Serum Ferritin, CRP, D- Dimer . IL-6) will be observed till its normal level. | 30 days | 
| Oxygen Saturation | Patients who were given Tocilizumab, observed for demand of oxygen therapy to see decremental response of oxygen, whether its decreasing or increasing after tocilizumab dosing and it will be observed both in pulse oximeter and oxygen given in L/min. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytokine Release Syndrome, Covid-19 Pneumonia, Tocilizumab