Publication Mukae H, Antimicrob Agents Chemother (2022) (published paper)
Dates: 2021-09-28 to 2022-01-30
Funding: Mixed (Shionogi & Co., Ltd ; Japan Agency for Medical Research and Development. Employees of Shionogi & Co., Ltd. participated in and approved the design and conduct of the study, wrote the protocol, and were involved in the collection, management, analysis, and interpretation of data. Institutional authors reviewed and approved the protocol and collected and interpreted the data.)
Conflict of interest: Yes
Blinding: triple blinding
Multicenter / Japan |
Follow-up duration (days): 28
Initial dose: 750 mg orally on day 1 - Maintenance dose: 250 mg orally on days 2-5.
Initial dose: 375 mg orally on day 1 - Maintenance dose: 125 mg orally on days 2-5.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n= 40/ Asymptomatic: n=7
Number of vaccinated participants: 25
|In the register|
Change in virus titer of SARS-CoV-2 from baseline at each time point
|In the report|
Change from baseline (day 1, before drug administration) in SARS-CoV-2 viral titer on days 2, 4, 6, 9, 14, and 21 (or study discontinuation).
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 pre-print article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the article reflect those in the registry. The trial (n = 69) its target sample size (n = 69). This paper reports on a part a of a 2 part phase 2 trial.
This study was updated on November 18th, 2022 with data extracted from the published report and after contact with authors.