Trial NCT04345614
Publication Miller J, Crit Care (2020) (published paper)
Dates: 2020-04-08 to 2020-05-13
Funding: Private (CalciMedica, Inc. )
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / USA Follow-up duration (days): 30 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Auxora Initial dose: 2.0 mg/kg IV infusion, maximum 250 mg followed by 1.6 mg/kg IV infusion, maximum 200 mg the next 2 days |
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Control
Standard care | |
Participants | |
Randomized participants : Standard care=9 Auxora=17 | |
Characteristics of participants N= 26 Mean age : NR 12 males Severity : Mild: n=0 / Moderate: n=26 / Severe: n=0 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 30 ] | |
In the report recovery rate defined as the first day the patient satisfied criterion 6, 7, or 8 of the 8-point ordinal scale | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
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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 all available versions of the published article, the study registry and supplementary appendix were used in data extraction and risk of bias assessment. The study was terminated early by the US Food and Drug Administration. As a result, the target sample size specified in the registry was not achieved. Quote "The FDA provided guidance on May 12, 2020, to limit further enrolment in the open-label study and transition to a randomized, blinded, placebo-controlled study, and as such, both arms A and B ceased further enrolment". The study reported the results in two arms based on severity of the disease. Data on the arm with patients requiring high flow oxygenation (Arm B) was not used in this review as the sample size (n=4) was too small. In the trial registration, the control treatment was intended to be Placebo but was Standard care in the published report. There was no change from the trial registration in the intervention and control treatments in the primary outcome. Some secondary outcomes (number of days in the ICU and CM4620-IE serum concentration) were reported in the registry and not in the published article. |