Outcomes
febrile, fever
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, SECONDARY, ADVERSE EVENT, RESOLUTION
The primary outcome measure was the viral clearance rate between days 0 and 7.All-cause admission to hospital for clinical deterioration (until day 28) was a secondary endpoint, as were determining optimal dosing and development of symptoms of the post-COVID-19 condition (also known as long-COVID; both will be reported elsewhere).The prespecified endpoint of time to resolution of fever and time to resolution of symptoms were assessed using survival methods as the data were right-censored at the last visit. Patients were defined as febrile at baseline if at least one axillary temperature measurement within 24 h of randomisation was 37·5°C or higher. Resolution of fever was defined as an axillary temperature 37·0°C or lower for at least 24 h. Resolution of symptoms was defined as no reported symptoms.Viral rebound was an exploratory outcome, and was defined as a mean daily oropharyngeal viral load which had declined to fewer than 100 genomes per mL for 2 or more consecutive days, followed by a viral load of more than 1000 genomes per mL at any timepoint thereafter.Adverse events were graded according to the Common Terminology Criteria for Adverse Events version 5.0. Summaries were generated if the adverse event was grade 3 or worse and was new or had increased in intensity. Serious adverse events were recorded separately and reported to the data safety monitoring board.