Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia

Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Canakinumab on Cytokine Release Syndrome in Patients With COVID-19-induced Pneumonia (CAN-COVID)

ClinicalTrials.gov Identifier: NCT04362813

Novartis Reference Number: CACZ885D2310

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).

Condition 
Pneumonia and Cytokine Release Syndrome (Covid-19)
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
451 participants
Start date 
Apr 30, 2020
Completion date 
Dec 22, 2020
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
Canakinumab
Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Drug
Placebo
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.

Eligibility Criteria

Key inclusion Criteria:

Adults ≥ 18 years old (for US only: patients ≥ 12 years old)
Body weight ≥40 kg
Informed consent must be obtained prior to participation in this study. For US patients 12 - < 18 years old; parent/guardian consent must be obtained and assent if applicable.
Clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology
Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with pulmonary infiltrates
SpO2 ≤ 93% on room air or arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg
C-reactive protein ≥20 mg/L or ferritin level ≥600 µg/L

Key exclusion Criteria:

History of hypersensitivity to canakinumab or to biologic drugs
Intubated and on mechanical ventilation (invasive) at time of randomization
Treatment with immunomodulators or immunosuppressant drugs, including but not limited to tocilizumab, TNF inhibitors and anti-IL-17 agents within 5 half-lives or 30 days (whichever is longer) prior to randomization with the exception of anakinra which is excluded within 5 half-lives only. Note: Immunomodulators (topical or inhaled) for asthma and atopic dermatitis and corticosteroids (any route of administration) are permitted.
Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19

Study Locations

United States
Novartis Investigative Site
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Birmingham, 35294
Alabama
United States
Novartis Investigative Site
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Glendale, 91206
California
United States
Novartis Investigative Site
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San Francisco, 94110
California
United States
Novartis Investigative Site
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San Francisco, 94143
California
United States
Novartis Investigative Site
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Chicago, 60611
Illinois
United States
Novartis Investigative Site
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Baltimore, 21201
Maryland
United States
Novartis Investigative Site
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Boston, 02115
Massachusetts
United States
Novartis Investigative Site
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Boston, 02118
Massachusetts
United States
Novartis Investigative Site
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Brooklyn, 11219
New York
United States
Novartis Investigative Site
-
Chapel Hill, 27599
North Carolina
United States
Novartis Investigative Site
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Cleveland, 44106-5000
Ohio
United States
Novartis Investigative Site
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Philadelphia, 19140
Pennsylvania
United States
Novartis Investigative Site
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Houston, 77030
Texas
United States
Novartis Investigative Site
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Richmond, 23298
Virginia
United States
Novartis Investigative Site
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Tacoma, 98405
Washington
United States
France
Novartis Investigative Site
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Toulouse Cedex 4, 31054
-
France
Italy
Novartis Investigative Site
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Bergamo, 24127
BG
Italy
Novartis Investigative Site
-
Cona, 44100
FE
Italy
Russian Federation
Novartis Investigative Site
-
Barnaul, 656045
-
Russian Federation
Novartis Investigative Site
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Moscow, 111539
-
Russian Federation
Novartis Investigative Site
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Moscow, 121309
-
Russian Federation
Novartis Investigative Site
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Moscow, 123056
-
Russian Federation
Novartis Investigative Site
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Moscow, 123182
-
Russian Federation
Novartis Investigative Site
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Ryazan, 390039
-
Russian Federation
Novartis Investigative Site
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S-Petersburg, 194354
-
Russian Federation
Novartis Investigative Site
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Saint Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
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Sestroretsk, 197706
-
Russian Federation
Novartis Investigative Site
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St Petersburg, 193312
-
Russian Federation
Spain
Novartis Investigative Site
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Hospitalet de Llobregat, 08907
Barcelona
Spain
Novartis Investigative Site
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Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
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San Sebastian de los Reyes, 28702
Madrid
Spain
Novartis Investigative Site
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Madrid, 28034
-
Spain
Novartis Investigative Site
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Madrid, 28040
-
Spain
Novartis Investigative Site
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Madrid, 28041
-
Spain
United Kingdom
Novartis Investigative Site
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Barnet, EN5 3DJ
-
United Kingdom
Novartis Investigative Site
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Coventry, CV2 2DX
-
United Kingdom
Novartis Investigative Site
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Leeds, LS9 7TF
-
United Kingdom
Novartis Investigative Site
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London, NW3 2QG
-
United Kingdom
Novartis Investigative Site
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London, SE5 9RS
-
United Kingdom

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Call 1-999-669-6682 or email [email protected]