Overview

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

Status:
Completed
Trial end date:
2020-12-22
Target enrollment:
0
Participant gender:
All
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 COVID-19-induced pneumonia and cytokine release syndrome (CRS).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
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