Outcomes.
cough, COVID-19-related symptoms, dyspnea, headache
INFECTIOUS DISEASES, SECONDARY, ADVERSE EVENT
From the beginning of the treatment (day 1) to the end of the follow-up period (day 28), saliva samples were obtained from patients once daily, and viral load was measured only using quantitative RT-PCR at the National Institute of Infectious Diseases (Tokyo, Japan). Furthermore, patients kept a daily diary to record the presence or absence of COVID-19-related symptoms, such as cough, dyspnea, or headache, from day 1 to day 28. They also recorded any untoward symptom as an adverse event. Abnormal findings in vital signs or laboratory values were collected if the investigators considered them necessary. Viral load data obtained before enrollment were not used for the analyses.The primary endpoint was the time to clearance of SARS-CoV-2, which was adjudicated by the assessors at the central laboratory. The assessors were blinded to the assigned treatment. Viral clearance was defined as negative results for two consecutive RT-PCR assays conducted using saliva samples. Time to viral clearance was defined as the time from the inclusion to the day when the first negative result was obtained in case of viral clearance.The secondary endpoints included the AUC and the half-life of the viral load. In addition to these secondary endpoints, the time to resolution of all COVID-19-related symptoms and that of each symptom were recorded for patients with mild symptoms. An Effectiveness and Safety Assessment Committee was established independently of the physicians associated with the trial to review the overall safety and efficacy of the trial following standard operating procedures.