Publication Holubar M, Clin Infect Dis (2022) (published paper)
Dates: 2020-07-08 to 2021-03-23
Funding: Public/non profit (Anonymous donors to Stanford University)
Conflict of interest: No
Blinding: double blinding
Single center / USA |
Follow-up duration (days): 28
Initial dose: 1800 mg orally twice a day on day 1 - Maintenance dose: 800 mg orally twice a day on days 2-10.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n= 135/ Asymptomatic: n=14
Number of vaccinated participants: NR
|In the register|
Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ] Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
|In the report|
SARS-CoV-2 shedding cessation, defined as the time from enrollment to the first of two consecutive negative nasal RT-PCRs
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 preprint and published articles, the supplemental data and study registry were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The registry primary outcome reflects the reported primary outcome. Some outcomes (e.g. mortality, hospitalization, adverse events) are reported in the paper, but were not pre-specified in the trial registry. The trial (n = 149) achieved its original target sample size (n = 120), but with 116 PCR-positive patients (days 1-3) did not achieve the amended target sample size for PCR-positive patients (n = 120).
This study was updated on May 11th, 2022 with data extracted from the final published report.