Trial NCT04343989
Publication Lonze B, Crit Care Med (2022) (published paper)
Dates: 2020-04-01 to 2020-12-03
Funding: Mixed (This study was funded by a grant from the Jack Rudin Family
Foundation to Dr. Lonze. Clazakizumab was provided at no cost to the investigators by Vitaeris, recently acquired by CSL Behring. No corporate monetary support was provided. Vitaeris provided advice on the study design but had no role in conduct of the
study, data collection, analysis, or interpretation. CSL Behring
had no role in the study design, study conduct, data collection,
analysis, or interpretation.)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / USA Follow-up duration (days): 60 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
Clazakizumab 12.5 12.5 mg IV single dose. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. Clazakizumab 25 mg IV single dose. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. |
|
Control
Placebo | |
Participants | |
Randomized participants : Placebo=74 Clazakizumab 12.5=26 Clazakizumab=78 | |
Characteristics of participants N= 178 Mean age : NR 123 males Severity : Mild: n=0 / Moderate: n=25 / Severe: n=90 Critical: n=37 Number of vaccinated participants: NR | |
Primary outcome | |
In the register 1) Ventilator Free Survival [ Time Frame: 28 days ] Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days; 2) Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab [ Time Frame: 60 days ] | |
In the report 28-day ventilator free survival | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported |
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 |
Some concerns |
General comment | In addition to the published article, the study registry, protocol/SAP were used in data extraction and risk of bias assesment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry original primary outcome does not reflect the current primary outcome. This study reports on the results of the high-dose clazakizumab only since the Safety and Monitoring Board (DSMB) recommended dropping of the low-dose arm after interim analysis. |