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

Completed

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

• Registration Number: NCT04873141
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Brief Summary

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

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 Timeline

• Study Start: 2020-04-28
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Study First Submitted: 2021-04-28
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Study First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)	All the patients suffering from severe covid pneumonia and laboratory parameter suggestive of cytokine release syndrome.

Primary Outcome Measures

Name	Time	Method
Mortality Rate	28 days	Patient admitted with cytokine release syndrome and given Tocilizumab and primary outcome was death within hospital.
Time to discharge	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Laboratory parameters	30 days	All the specialized labs (Serum Ferritin, CRP, D- Dimer . IL-6) will be observed till its normal level.
Oxygen Saturation	30 days	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.

Trial Locations

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University; 🇵🇰 Islamabad, Pakistan