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

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

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.

Study Overview

• Status: Completed
• Conditions: Cytokine Release Syndrome; Covid-19 Pneumonia
• Intervention / Treatment: Drug: Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of age (18-all) and suffering from COVID- 19 severe pneumonia

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case Group; 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); Tocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS).; Other Names: Actemra

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
• Investigators: Principal Investigator: Muhammad Hassan, MD, Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): June 22, 2020
• Study Completion (Actual): June 22, 2020

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Tocilizumab; Covid-19 Pneumonia; Cytokine Release Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease; Shock; COVID-19; Syndrome; Pneumonia; Cytokine Release Syndrome
• Other Study ID Numbers: Tocilizumab and CRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study was completed and we retrospectively putting data of a prospective study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No