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NCT04348448 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04348448
Other study ID # CANASCOV
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date September 1, 2020

Study information
Verified date April 2020
Source AUSL Romagna Rimini
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date September 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Canakinumab 150 MG/ML [Ilaris]
COVID-19

Locations
Country Name City State
Italy Ausl della Romagna Ravenna

Sponsors (1)
Lead Sponsor Collaborator
AUSL Romagna Rimini

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 ICU stay times ICU stay times 9 months
Secondary % died after 1 month after treatment percentage of patients who died 1 month after treatment 9 months
Secondary hospitalization time of hospitalization 9 months
Secondary adverse event number of adverse event 9 months
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