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

NCT04873141 | Completed FDA Drug

• 1 other identifier: Tocilizumab and CRS
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytokine Release Syndrome; Covid-19 Pneumonia

Keywords

Cytokine Release Syndrome; Covid-19 Pneumonia; Tocilizumab

Outcome Measures

Primary Outcomes (2)

• Mortality Rate

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

  28 days

• 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 Outcomes (2)

• Laboratory parameters

  30 days

• Oxygen Saturation

  30 days

Study Arms (1)

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)

Interventions

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).

Also known as: Actemra

Case Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of age (18-all) and suffering from COVID- 19 severe pneumonia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Cytokine Release Syndrome

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Muhammad Hassan, MD

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 5, 2021
• Study Start: April 28, 2020
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)