Observational Study, Use of Canakinumab Administered Subc... | NCT04348448

Studies
Observational Study, Use of Canakinumab Administered Subcutaneously in the Treatment COVID-19 Pneumonia

NCT04348448

Sponsor

AUSL Romagna Rimini

Status

Terminated

Last Update Posted

Jul 21, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Canakinumab 150 MG/ML [Ilaris]

Countries

Italy

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

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to covid

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

Sep 1, 2020Actual

First Submitted Date

Apr 13, 2020

First Submission Date that Met QC Criteria

Apr 13, 2020

First Posted Date

Apr 16, 2020Actual

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

Jul 19, 2023

Last Update Posted Date

Jul 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all COVID-19 pneumonia patients treated with canakinumab administered subcutaneously.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
Canakinumab 150 MG/ML [Ilaris]	Drug	COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intensive care treatment	percentage of patients treated with canakinumab sc who do not require intensive care treatment during hospitalization for COVID-19	9 months

Secondary Outcomes

Measure	Description	Time Frame
ICU stay times	ICU stay times	9 months
% died after 1 month after treatment	percentage of patients who died 1 month after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with COVID 19 who have received or are candidates to receive treatment with canakinumab subcutaneously
Age> 18 years
Pneumonia diagnosed with Chest X-ray / or Chest CT

Exclusion Criteria:

Patients with Covid19-related pathology in the context of another cause of major admission (trauma, surgery)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

patients with COVID 19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ausl della Romagna		Ravenna		48121	Italy

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
C541220	canakinumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided