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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04348448
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
COVID-19 Drug: Canakinumab 150 MG/ML [Ilaris]

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Canakinumab

Intervention Details:
  • Drug: Canakinumab 150 MG/ML [Ilaris]

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. ICU stay times [ Time Frame: 9 months ]
    ICU stay times

  2. % died after 1 month after treatment [ Time Frame: 9 months ]
    percentage of patients who died 1 month after treatment

  3. hospitalization [ Time Frame: 9 months ]
    time of hospitalization

  4. adverse event [ Time Frame: 9 months ]
    number of adverse event

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with COVID 19

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)
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Responsible Party: AUSL Romagna Rimini Identifier: NCT04348448    
Other Study ID Numbers: CANASCOV
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs