The ACTG is working with Novartis to conduct additional clinical trials. Information can be found below.
C5398: Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia (CAN-COVID)
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 adult patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
Who can join?
Key inclusion Criteria:
- Adults (≥ 18 years old)
- Body weight ≥40 kg
- Informed consent must be obtained prior to participation in this study.
- 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
What do I need to do?
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.
For more information about this study please visit clinicaltrials.gov page