Trial NCT04365153
Publication The three C study - Cremer P, Eur Heart J (2021) (published paper)
Dates: 2020-04-28 to 2020-08-25
Funding: Private (Novartis
)
Conflict of interest: No
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / USA Follow-up duration (days): 150 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Canakinumab 300 300 mg IV single dose Canakinumab 600 600 mg IV single dose |
|
Control
Placebo | |
Participants | |
Randomized participants : Placebo=16 Canakinumab 300=14 Canakinumab 600=15 | |
Characteristics of participants N= 45 Mean age : NR 33 males Severity : Mild: n=4 / Moderate: n=20 / Severe: n=11 Critical: n=10 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Clinical Improvement at Day 14 [ Time Frame: Up to day 14 ] (Number of patients with either an improvement of two points on a seven category ordinal scale or discharge from the hospital) | |
In the report Time to clinical improvement up to day 14, defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurred first | |
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 two published articles, the study registry (with outcome data posted online) and the protocol were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the population, intervention and control treatments, or in the primary outcomes.
On 10th of August, 2021, this study was updated based on the published report in European Heart Journal. |