Trial NCT04362813; EudraCT 2020-001370-30
Publication Caricchio R, JAMA, 2021 (published paper)
Dates: 2020-04-30 to 2020-08-17
Funding: Private (Novartis Pharma AG )
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / France, Italy, Russia, Spain, UK and USA Follow-up duration (days): 28 | |
| Inclusion criteria | Hospitalized patients with severe COVID-19; at least 12 years old (United States) or 18 years old (Europe); hypoxemia but did not require IMV; diagnosis of infection with SARS- CoV-2 within 7 days prior to randomization; diagnosis of pneumonia with pulmonary infiltrates on chest x-ray or computed tomographic scan within 5 days prior to randomization; peripheral capillary oxygen saturation of 93% or less on room air or arterial oxygen partial pressure/fraction of inspired oxy- gen less than 300 mm Hg,; blood levels of CRP of 20 mg/L or greater or ferritin of 600 μg/L or greater. |
| Exclusion criteria | Treated with therapies targeting IL-1 or IL-6; suspected or known untreated active infection due to another pathogen; if progression to death was imminent within 24 hours according to the investigator. |
| Interventions | |
| Treatment
Placebo * |
|
| Control
Canakinumab ( / ) | |
| Participants | |
| Randomized 454 participants (n1=227 / n2= 227) | |
| Characteristics of participants N=454 Mean age : 58.2 267 males Severity : Mild: n=26 / Moderate: n=321/ Severe: n=104 Critical: n=0 | |
| Primary outcome | |
| In the register Patients who survived without requiring invasive mechanical ventilation from Day 3 to Day 29 | |
| In the report The proportion of patients who survived without ever requiring IMV from day 3 to day 29 (inclusive). | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
|
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
| General comment |
In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were no substantive differences between the published article and the registry in population, procedures, interventions or outcomes. The report describes the participants as having severe COVID-19, and chest x-ray or CT scan and blood oxygen inclusion criteria indicate severe disease. However, assessments at baseline on the WHO ordinal scale range from Mild (Hospitalized, no oxygen therapy) to Severe (Noninvasive ventilation or high-flow oxygen). And this scale has been used to categorize patients for this extraction. The study achieved its target sample size. The study reports an interim analysis including data up to day 29.
This study was updated on October 25th, 2021 with data from contact with authors. |