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

July 19, 2023 updated by: AUSL Romagna Rimini

Observational Study on the Use of Canakinumab Administered Subcutaneously in the Treatment of Patients With COVID-19 Pneumonia

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.

Study Overview

Status

Terminated

Conditions

COVID-19

Intervention / Treatment

Drug: Canakinumab 150 MG/ML [Ilaris]

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Ravenna, Italy, 48121
    - AUSL della Romagna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

patients with COVID 19

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay times Time Frame: 9 months	ICU stay times	9 months
% died after 1 month after treatment Time Frame: 9 months	percentage of patients who died 1 month after treatment	9 months
hospitalization Time Frame: 9 months	time of hospitalization	9 months
adverse event Time Frame: 9 months	number of adverse event	9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AUSL Romagna Rimini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria