Trial NCT04362813; EudraCT 2020-001370-30
Publication CAN-COVID - Caricchio R, JAMA (2021) (published paper)
Dates: 2020-04-30 to 2020-08-17
Funding: Private (Novartis Pharma AG )
Conflict of interest: Yes
Blinding: double blinding
Multicenter / France, Italy, Russia, Spain, UK and USA |
Follow-up duration (days): 28
Single dose infused IV over 2 hours: 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg, 750 mg for >80 kg in 250 mL of 5% dextrose.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=26 / Moderate: n=321 / Severe: n=104 Critical: n=0
Number of vaccinated participants: 0
|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).
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
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.
This study was updated on September 28th, 2022 with data extracted from the registry.