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There is an unmet medical need for effective treatments for hospitalized patients with coronavirus disease 2019 (COVID-19). Ribavirin is a broad-spectrum antiviral with demonstrated in vitro activity against multiple viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This trial evaluated the potential of ribavirin inhalation solution (ribavirin aerosol) to reduce COVID-19 disease severity in adults with confirmed SARS-CoV-2 infection and a diagnosis of respiratory distress. This phase I, multicenter, open-label, nonrandomized trial was conducted from February 2021 through August 2021. Patients received ribavirin aerosol (100 mg/ml for 30 min or 50 mg/ml for 60 min) twice daily for up to 6 days. The primary end point was change from baseline in clinical status severity, rated on a 7-point scale (1 [death]; 7 [not hospitalized; no limitations on activities]), at day 7 (or end-of-treatment/early termination) and day 30 (follow-up). Fifty-one patients were treated with ribavirin aerosol (mean age, 51.5 years; 78.4% men); mean number of doses was 9.7 (range, 1-12). Improvement of =1 level in clinical status severity was observed in 31.4% (16/51) and 78.4% (40/51) of patients at end-of-treatment and day 30, respectively. Of 21 patients who required a ventilator, 16 (76.2%) were able to discontinue ventilator use. Five patients (9.8%) died between end-of-treatment and day 30. Three patients (5.9%) discontinued study treatment due to adverse events. No deaths were considered related to study treatment. These data provide preliminary evidence that ribavirin aerosol may be an efficacious treatment for respiratory distress in adults with COVID-19. [ABSTRACT FROM AUTHOR]

Aims: Oral treatment extended-release naltrexone/bupropion (NB) leads to significant weight loss, but its effect on body composition remains unclear. We investigated changes in body composition with dual-energy x-ray absorptiometry after treatment with NB or placebo in a subgroup of participants from a randomized control phase 3 study (COR-I)., Materials and Methods: Observed changes from baseline to week 52 were estimated for total, lean, and fat mass. Changes in body composition were evaluated using linear regression and adjusted for baseline covariates., Results: The analysis included 82 participants (placebo, n = 26; NB, n = 56) with comparable baseline characteristics (age, BMI, sex). The NB group experienced a significant -7.8% change of total mass (-12.9% change in fat mass and -4.1% in lean mass), compared with a -2.8% change of total mass (-4.8% change in fat mass and -1.4% in lean mass) in the placebo group. The adjusted changes in lean-to-fat mass ratio of 0.069 in the NB group and -0.056 in the placebo group were significantly different (p < 0.05)., Conclusions: NB-induced weight loss is associated with significant reductions in total percent fat mass, increase in total percent lean mass, and change in lean-to-fat mass ratio, in comparison to placebo. Larger studies are needed to further elucidate the clinical significance of these changes and impact of a potentially healthier metabolism., (© 2025 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)