Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is an enveloped, single-stranded RNA virus. Favipi-ravir is an orally administrable antiviral drug whose mechanism of action is to selectively inhibit RNA-dependent RNA polymerase. A preliminary trial in COVID-19 patients reported significant improvements across a multitude of clinical parameters, but these findings have not been confirmed in an adequate well-controlled trial. We conducted a randomized, single-blind, placebo-controlled Phase III trial assessing the efficacy and safety of favipiravir in patients with
Background: The pharmacokinetics and appropriate dose regimens of favipiravir are unknown in hospitalized influenza patients; such data are also needed to determine dosage selection for favipiravir trials in COVID-19. Methods: In this dose-escalating study, favipiravir pharmacokinetics and tolerability were assessed in critically ill influenza patients. Participants received one of two dosing regimens; Japan licensed dose (1600 mg BID on day 1 and 600 mg BID on the following days) and the higher dose (1800 mg/800 mg BID) trialed in uncomplicated influenza. The primary pharmacokinetic endpoint was the proportion of patients with a minimum observed plasma trough concentration (C trough) 20 mg/L at all measured time points after the second dose. Results: Sixteen patients were enrolled into the low dose group and 19 patients into the high dose group of the study. Favipiravir C trough decreased significantly over time in both groups (p <0.01). Relative to day 2 (48 hrs), concentrations were 91.7% and 90.3% lower in the 1600/600 mg group and 79.3% and 89.5% lower in the 1800/800 mg group at day 7 and 10, respectively. In contrast, oseltamivir concentrations did not change significantly over time. A 2-compartment disposition model with first-order absorption and elimination described the observed favipiravir concentration-time data well. Modeling demonstrated that less than 50% of patients achieved C trough 20 mg/L for >80% of the duration of treatment of the two dose regimens evaluated (18.8% and 42.1% of patients for low and high dose regimen, respectively). Increasing the favipravir
The main factor that affects the prognosis of patients with head and neck cancer (HNC) is regional lymph node metastases. For this reason, the accurate evaluation of neck metastases is required for neck management. This study investigates the sentinel lymph node identification and the accuracy of the histopathology of the sentinel lymph node in patients with HNC. Eleven patients with histologically proven oral squamous cell carcinoma accessible to radiocolloid injection were enrolled in this study. Using both lymphoscintigraphy and a handheld gamma probe, the sentinel lymph node could be identified in all 11 patients. Subsequently, the sentinel lymph nodes and the neck dissection specimen were examined for lymph node involvement due to tumor. The histopathology of sentinel lymph nodes was consistent with the pathological N classification in all 11 patients. Furthermore, the histopathology of sentinel lymph nodes was superior to physical examination, computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) scan. The results of this study indicate that sentinel lymph node identification is technically feasible and predicts cervical metastases in patients with oral cavity cancer. This may be a useful diagnostic technique for identifying lymph node disease in staging lymph node dissection.
It is possible to use a smaller number of subjects in thorough QT studies in Japan than in Europe and the US utilizing moxifloxacin as a positive control. There were no detectable effects of favipiravir on the QT/QTc interval.
Transcutaneous electrical stimulation was applied to the penis in 22 patients complaining of frequency, urgency and/or urge incontinence. Detrusor activity was suppressed with this stimulation, causing decreased bladder spasticity and/or increased cystometric capacity in 10 of 22 patients. Clinical success was noted in four patients with a portable stimulator.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.