Publication NCT04369469, Unpublished (2022) (results posted on registry)
Dates: 2020-05-10 to 2021-01-13
Funding: Not reported/unclear
Conflict of interest: *
Multicenter / France, Japan, Spain, UK, USA |
Follow-up duration (days): 90
A weight-based dose (≥40 to < 60 kg/2400 mg, 60 to < 100 kg/2700 mg, ≥100 kg/3000 mg) IV on Day 1.
600 mg (≥40 to <60 kg) or 900 mg (>60 kg) IV on Day 5 and Day 10.
900 mg IV on Day 15.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
|In the register|
Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 [ Time Frame: Day 29 ]
|In the report|
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
|General comment||This is an unpublished trial whose results have been reported in ClinicalTrials.gov. The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The study was terminated. According to the registy, "Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021."|