Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study

NCT04893031 | Completed DMC

• 2 other identifiers: 2021/242021-01-24T17_19_44
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. In this study the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.

Conditions

Tocilizumab; COVID-19; Critical Care; Mortality

Keywords

tocilizumab; COVID-19; Critical Care; Mortality

Outcome Measures

Primary Outcomes (1)

• Rates of intensive care mortality in the groups

  all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit.

  28 Day

Secondary Outcomes (1)

• Rates of needed of mechanical ventilation in the groups

  28 Day

Study Arms (2)

Tocilizumab treatment group

Symptoms of hypoxia and systemic inflammation (SpO2 \<90% on room air with accompanying elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrations on chest radiography or rapid progression of existing infiltrations, but who did not need mechanical ventilation at admission and were given tocilizumab treatment.

Drug: Tocilizumab

Standard treatment group

Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization.

Interventions

Tocilizumab DRUG

400mg or 800 mg IV tocilizumab treatment according to patient clinical severity

Tocilizumab treatment group

Eligibility Criteria

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

Study Population

Patients were diagnosed with COVID-19 and were admitted to intensive care unit

You may qualify if:

• All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia

You may not qualify if:

• Patients who require mechanical ventilation in intensive care admission
• Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission
• patients for whom tocilizumab is contraindicated

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Colsuntant Intensivist

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 19, 2021
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year

Locations

TU (1)