Trial NCT04345614
Publication CARDEA - Bruen C, Crit Care (2022) (published paper)
Dates: 2020-09-08 to 2021-05-24
Funding: Private (CalciMedica, Inc. (La Jolla, CA, USA))
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / USA Follow-up duration (days): 60 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
Auxora Initial dose: 2.0 mg/kg IV on day 1 - Maintenance dose: 1.6 mg/kg IV on days 2 and 3 |
|
Control
Placebo | |
Participants | |
Randomized participants : Placebo=141 Auxora=143 | |
Characteristics of participants N= 284 Mean age : NR 190 males Severity : Mild: n=0 / Moderate: n=98 / Severe: n=164 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Number of days from the Start of the First Infusion of Study Drug (SFISD) to recovery [ Time Frame: From start of first infusion of study drug to day 60 ] | |
In the report Time to recovery through Day 60, defined as meeting the criteria for category 6 (Hospitalized, not requiring supplemental oxygen or ongoing medical care), category 7 (Discharged, requiring supplemental oxygen), or category 8 (Discharged, not requiring supplemental oxygen) using an 8-point ordinal scale. | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes |
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, pre-print article, the protocol, the SAP, the supplementary material, the study registry and data from contact with authors were used in data extraction and risk of bias assessment. The study terminated early due to declining rates of US COVID-19 hospitalizations in the spring of 2021, and the adoption of tocilizumab as standard of care in patients at many study sites. Consequently. The trial (n = 284) did not achieve its target sample size (n = 400). There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. The study was first posted to SSRN but was later removed.
The study was updated on February 2nd, 2022 with data from the Research Square report. The study was updated on April 28th, 2022 with data acquired after contact with authors. The study was updated on May 11th, 2022 with data from the published report. |