Trial NCT04657497; jRCT2031200198
Publication CANDLE - Kinoshita T, BMC Medicine (2022) (published paper)
Dates: 2020-11-09 to 2021-03-30
Funding: Private (Ono Pharmaceutical Co., Ltd)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / Japan Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Camostat Mesilate 600 mg orally four times daily for up to 14 days. |
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Control
Placebo | |
Participants | |
Randomized participants : Camostat Mesilate=78 Placebo=77 | |
Characteristics of participants N= 155 Mean age : NR 78 males Severity : Mild: n=108 / Moderate: n=0 / Severe: n=0 Critical: n=0 Number of vaccinated participants: 0 | |
Primary outcome | |
In the register Time to SARS-CoV-2 negative test [ Time Frame: Up to 14 days ] | |
In the report Time to the first two consecutive negative SARS-CoV-2 tests | |
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 pre-print article, the prospective protocol, statistical analysis plan, supplementary appendix and prospective study registry were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The primary and secondary outcomes indicated in protocol and registry reflect the outcomes reported in the paper. The study (n=155) achieved the target sample size (n=110) specified in the protocol.
On October 20tg, 2020, this study was updated with information extracted from the publication. |