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NCT Number: NCT04873141

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

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.

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Key information

Conditions

Cytokine Release Syndrome COVID-19 Pneumonia Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Other names: Actemra

Primary outcomes

  1. Mortality Rate

    Time frame: 28 days

    Patient admitted with cytokine release syndrome and given Tocilizumab and primary outcome was death within hospital.

  2. Time to discharge

    Time frame: 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 outcomes

  1. Laboratory parameters

    Time frame: 30 days

    All the specialized labs (Serum Ferritin, CRP, D- Dimer . IL-6) will be observed till its normal level.

  2. Oxygen Saturation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2021
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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