Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

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).

Official Title

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)

Details

This is 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 syndrome (CRS). The study will enroll patients to canakinumab or placebo, in addition to standard of care (SOC) per local practice, which may include anti-viral treatment, corticosteroids and/or supportive care.

Patients who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio to either canakinumab + SOC or placebo + SOC and can be dosed immediately after ensuring that the patient has met all eligibility criteria. Patients in the canakinumab arm will be dosed on Day 1 with canakinumab 450 mg for body weight of 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. Patients in the placebo arm will be administered with 250 mL of 5% dextrose infused IV over 2 hours.

The study will include:

  • Screening period of 0-1 day
  • Study period from initial dose on Day 1 to Day 29 or hospital discharge
  • Follow-up to Day 127 The primary objective is to demonstrate the benefit of canakinumab + SOC in increasing the chance of survival without ever requiring invasive mechanical ventilation among patients with COVID-19-induced pneumonia and CRS.

Keywords

Pneumonia and Cytokine Release Syndrome (Covid-19) COVID-19 pneumonia cytokine release syndrome SARS-CoV-2 canakinumab Pneumonia Syndrome

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Novartis Investigative Site
    San Francisco California 94143 United States
  • Novartis Investigative Site
    San Francisco California 94110 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04362813
Phase
Phase 3
Study Type
Interventional
Last Updated