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

NCT ID: NCT04873141

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-28

Study Completion Date

2020-06-22

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.

Conditions

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Cytokine Release Syndrome Covid-19 Pneumonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Case Group

All the patients suffering from severe covid pneumonia and laboratory parameter suggestive of cytokine release syndrome.

Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)

Intervention Type DRUG

Tocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS).

Interventions

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Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)

Tocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS).

Intervention Type DRUG

Other Intervention Names

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Actemra

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Fibhaa Syed

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University

Locations

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Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Tocilizumab and CRS

Identifier Type: -

Identifier Source: org_study_id

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