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
Blinding: double blinding
Multicenter / USA |
Follow-up duration (days): 60
Initial dose: 2.0 mg/kg IV on day 1 - Maintenance dose: 1.6 mg/kg IV on days 2 and 3
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=98 / Severe: n=164 Critical: n=0
Number of vaccinated participants: NR
|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.
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, 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.