Observational Study, Use of Canakinumab Administered Subcutaneously in the Treatment COVID-19 Pneumonia
Sponsor
AUSL Romagna Rimini (Other)
Overall Status
Unknown status
CT.gov ID
NCT04348448
Collaborator
(none)
100
5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study on the Use of Canakinumab Administered Subcutaneously in the Treatment of Patients With COVID-19 Pneumonia
Anticipated Study Start Date
:
Apr 1, 2020
Anticipated Primary Completion Date
:
Jul 1, 2020
Anticipated Study Completion Date
:
Sep 1, 2020
Outcome Measures
Primary Outcome Measures
- 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
- ICU stay times [9 months]
ICU stay times
- % died after 1 month after treatment [9 months]
percentage of patients who died 1 month after treatment
- hospitalization [9 months]
time of hospitalization
- adverse event [9 months]
number of adverse event
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AUSL Romagna Rimini
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AUSL Romagna Rimini
ClinicalTrials.gov Identifier:
NCT04348448
Other Study ID Numbers:
- CANASCOV
First Posted:
Apr 16, 2020
Last Update Posted:
Apr 16, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: