Phase 3
N=454
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04362813 ↗Enrolled (actual)
454
Serious AEs
22.3%
Results posted
Aug 2021
Primary outcome: Primary: Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis — 198; 191 Participants — p=0.2874
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Canakinumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis |
198; 191 | 0.2874 |
| SECONDARY COVID-19-related Death After Study Treatment |
11; 16 | 0.3303 |
| SECONDARY Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) |
0.726; 0.785; 0.479; 0.649; 0.255; 0.384 | — |
| SECONDARY Geometric Mean Ratio to Baseline in the D-dimer |
1.032; 1.028; 0.992; 1.188; 1.094; 1.188 | — |
| SECONDARY Geometric Mean Ratio to Baseline in Ferritin |
0.996; 1.014; 0.921; 1.014; 0.825; 0.879 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
141; 140 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04362813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.