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

Terminated

• Conditions: COVID-19

• Registration Number: NCT04348448
• Lead Sponsor: AUSL Romagna Rimini

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 available

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Primary Completion: 2020-05-01
• Study Completion: 2020-09-01
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
adverse event	9 months	number of adverse event
ICU stay times	9 months	ICU stay times
hospitalization	9 months	time of hospitalization
% died after 1 month after treatment	9 months	percentage of patients who died 1 month after treatment

Trial Locations

Locations (1)

Ausl della Romagna; 🇮🇹 Ravenna, Italy