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)
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.
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).
Pneumonia and Cytokine Release Syndrome (Covid-19)
Active, not recruiting
Oct 09, 2020
Apr 30, 2020
Dec 22, 2020
12 Years and older (Child, Adult, Older Adult)
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.
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
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