Evaluation of Acebilustat, a Selective Inhibitor of Leukotriene B4 Biosynthesis, for Treatment of Outpatients With Mild-Moderate Coronavirus Disease 2019: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.

BACKGROUND: The vast majority of coronavirus disease 2019 (COVID-19) disease occurs in outpatients where treatment is limited to antivirals for high-risk subgroups. Acebilustat, a leukotriene B4 inhibitor, has potential to reduce inflammation and symptom duration. METHODS: In a single-center trial spanning Delta and Omicron variants, outpatients were randomized to 100 mg/d of oral acebilustat or placebo for 28 days. Patients reported daily symptoms via electronic query through day 28 with phone follow-up on day 120 and collected nasal swab samples on days 1-10. The primary outcome was sustained symptom resolution to day 28. Secondary 28-day outcomes included time to first symptom resolution, area under the curve (AUC) for longitudinal daily symptom scores, duration of viral shedding through day 10, and symptoms on day 120. RESULTS: Sixty participants were randomized to each study arm. At enrollment, the median duration was 4 days (interquartile range, 3-5 days), and the median number of symptoms was 9 (7-11). Most patients (90%) were vaccinated, with 73% having neutralizing antibodies. A minority of participants (44%; 35% in the acebilustat arm and 53% in placebo) had sustained symptom resolution at day 28 (hazard ratio, 0.6 [95% confidence interval, .34-1.04]; P = .07 favoring placebo). There was no difference in the mean AUC for symptom scores over 28 days (difference in mean AUC, 9.4 [95% confidence interval, -42.1 to 60.9]; P = .72). Acebilustat did not affect viral shedding or symptoms at day 120. CONCLUSIONS: Sustained symptoms through day 28 were common in this low-risk population. Despite this, leukotriene B4 antagonism with acebilustat did not shorten symptom duration in outpatients with COVID-19. Clinical Trials Registration. NCT04662060.

Development and outcomes of a psychiatric pharmacy clinic for indigent patients.

PURPOSE: The development and outcomes of an outpatient psychiatric pharmacy clinic serving a mostly indigent Hispanic population are described. SUMMARY: Su Clinica Familiar (SCF) is a community health center in Texas's Lower Rio Grande Valley that sees over 30,000 patients a year, 20% of whom have a psychiatric disorder. In 2005 SCF began collaborating with a psychiatric clinical pharmacist to provide free psychiatric services within the health center. SCF patients with mental health complications were referred to the clinic by their primary care provider. Consultation notes were reviewed by the medical director, and treatment, if approved, was begun the same day. During the period from April 2005 to June 2006, 96 (77%) of 125 patients referred to the psychiatric pharmacy clinic actually attended it. Fifty-three (72%) of the 74 patients who were asked to return for follow-up care returned. Over 90% of the pharmacist's clinical recommendations were accepted. Most referrals were for depression, anxiety, and cognitive impairment; other referrals were for insomnia, medication education, and smoking cessation. The medications most frequently prescribed were sertraline and donepezil. Cost savings were estimated at $22,380. CONCLUSION: A psychiatric pharmacy clinic in an underserved region appeared to benefit patients' mental health and save money.