Study of efficacy and safety of canakinumab treatment for CRS in participants with COVID-19-induced pneumonia.
- Conditions
- COVID-19-induced pneumonia (CAN-COVID)Therapeutic area: Diseases [C] - Immune System Diseases [C20]MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862
- Registration Number
- EUCTR2020-001370-30-HU
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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) < 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m))
8.C-reactive protein =20 mg/L or ferritin level =600 µg/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 405
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- To evaluate change in clinical serologic measurements related to CRS in COVID-19 patients with pneumonia<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - COVID-19-related death during the 4-week period after study treatment<br>- Adjusted geometric mean ratio to baseline overtime up to Day 29 in the following clinical chemistry measurements:<br> o CRP<br> o Serum ferritin<br> o D-dimer<br>- Number of participants with Adverse Event (AE), serious adverse events (SAE), clinically significant changes in laboratory measures, and vital signs. <br><br>;Timepoint(s) of evaluation of this end point: Duration of trial