COVID-19-induced pneumonia (CAN-COVID) MedDRA version: 20.1 Level: PT Classification code 10053983 Term: Corona virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Adults (= 18 years old) 3. Body weight =40 kg 4. Informed consent must be obtained prior to participation in this study. 5. Clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology within 7 days prior to randomization 6. Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan (taken within 5 days prior to randomization) with pulmonary infiltrates 7. SpO2 = 93% on room air or arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) =65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to canakinumab or to biologic drugs 2. Intubated and on mechanical ventilation (invasive) at time of randomization 3. Treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to anakinra, tocilizumab, TNF inhibitors and anti-IL-17 agents within 5 half-lives prior to randomization. Note: Immunomodulators (topical or inhaled) for asthma and atopic dermatitis and corticosteroids are not restricted. 4. Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19 5. Neutropenia with ANC <1000/mm3 6. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study 7. In the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours, irrespective of the provision of treatments 8. Current participation in any other investigational trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the benefit of canakinumab + SOC in increasing chance of survival without ever requiring invasive mechanical ventilation among patients with COVID-19-induced pneumonia and CRS.;Secondary Objective: - To demonstrate the benefit of canakinumab in reducing 4-week case fatality rate (CFR) among patients with COVID-19-induced pneumonia and CRS regardless of other subsequent clinical interventions - To evaluate change in clinical serologic measurements related to CRS in COVID-19 patients with pneumonia - To evaluate safety of canakinumab in patients with COVID-19-induced pneumonia and CRS.;Primary end point(s): Clinical response, defined as survival without ever requiring invasive mechanical ventilation from Day 3 (inclusive) up to Day 29 (inclusive). ;Timepoint(s) of evaluation of this end point: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - COVID-19-related death during the 4-week period after study treatment - Adjusted geometric mean ratio to baseline overtime up to Day 29 in the following clinical chemistry measurements: o CRP o Serum ferritin o D-dimer - Number of participants with Adverse Event (AE), serious adverse events (SAE), clinically significant changes in laboratory measures, and vital signs. ;Timepoint(s) of evaluation of this end point: Duration of trial | — |
Countries
France, Germany, Hungary, Italy, Spain, United Kingdom, United States
Contacts
Public ContactInformation&Communication Médicales
Novartis Pharma S.A.S.
Outcome results
None listed