Effect of Tocilizumab on Intensive Care Patients With COV... | NCT04893031

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

NCT04893031

Sponsor

Karadeniz Technical University

Status

Completed

Last Update Posted

May 20, 2021Actual

Enrollment

213Actual

Phase

Not provided

Conditions

Tocilizumab
COVID-19
Critical Care
Mortality

Interventions

Tocilizumab

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-01-24T17_19_44	Other Identifier	Republic of Turkey Ministery of Health

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

May 10, 2021

First Submission Date that Met QC Criteria

May 10, 2021

First Posted Date

May 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2021

Last Update Posted Date

May 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehtap Pehlivanlar Küçük, Assistant professor, Colsuntant Intensivist, Karadeniz Technical UniversityPrincipal Investigator

Lead Sponsor

Karadeniz Technical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

With 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.

With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 <90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared.

In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

213Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tocilizumab	Drug	400mg or 800 mg IV tocilizumab treatment according to patient clinical severity	Tocilizumab treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Rates of needed of mechanical ventilation in the groups	Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.	28 Day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karadeniz Technical University		Trabzon		61080	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data can be shared with researchers if contact with corresponded.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

1 year

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C502936	tocilizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided