Study of efficacy and safety of canakinumab treatment for CRS in participants with COVID-19-induced pneumonia.

Phase 1

Conditions: COVID-19-induced pneumonia (CAN-COVID)
MedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2020-001370-30-GB

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 450

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) < 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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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