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

Covid-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873141
• Other study ID #: Tocilizumab and CRS
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: June 22, 2020

Study information

• Verified date: May 2021
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19 Pneumonia
• Cytokine Release Syndrome
• Pneumonia
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
Pakistan	Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate	Patient admitted with cytokine release syndrome and given Tocilizumab and primary outcome was death within hospital.	28 days
Primary	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	Laboratory parameters	All the specialized labs (Serum Ferritin, CRP, D- Dimer . IL-6) will be observed till its normal level.	30 days
Secondary	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