NCT04348448

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 21, 2023

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 13, 2020

Last Update Submit

July 19, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • ICU stay times

    9 months

  • % died after 1 month after treatment

    9 months

  • hospitalization

    9 months

  • adverse event

    9 months

Interventions

Canakinumab 150 MG/ML [Ilaris]DRUG

COVID-19

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with COVID 19

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ausl della Romagna

Ravenna, 48121, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

February 1, 2020

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

July 21, 2023

Record last verified: 2020-04

Locations

IT(1)