Status:
COMPLETED
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was 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 ...
Detailed Description
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab in patients with COVID-19-induced pneumonia and cytokine release ...
Eligibility Criteria
Inclusion
- Key inclusion Criteria:
- Adults ≥ 18 years old (for US only: patients ≥ 12 years old, although no children ever enrolled. This was an adult trial.)
- 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
Exclusion
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2020
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT04362813
Start Date
April 30 2020
End Date
December 22 2020
Last Update
January 24 2022
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Birmingham, Alabama, United States, 35294
2
Novartis Investigative Site
Glendale, California, United States, 91206
3
Novartis Investigative Site
San Francisco, California, United States, 94110
4
Novartis Investigative Site
San Francisco, California, United States, 94143