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

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04873141

Collaborator

(none)

Enrollment

Location

1.8

Actual Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytokine Release Syndrome Covid-19 Pneumonia	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

24 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 28, 2020

Actual Primary Completion Date :

Jun 22, 2020

Actual Study Completion Date :

Jun 22, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.