OBJECTIVES: Remdesivir shortens time to recovery in adults with severe coronavirus disease 2019 (COVID-19), but its efficacy and safety in children are unknown. We describe outcomes in children with severe COVID-19 treated with remdesivir. METHODS: Seventy-seven hospitalized patients <18 years old with confirmed severe acute respiratory syndrome coronavirus 2 infection received remdesivir through a compassionate-use program between March 21 and April 22, 2020. The intended remdesivir treatment course was 10 days (200 mg on day 1 and 100 mg daily subsequently for children ≥40 kg and 5 mg/kg on day 1 and 2.5 mg/kg daily subsequently for children <40 kg, given intravenously). Clinical data through 28 days of follow-up were collected. RESULTS: Median age was 14 years (interquartile range 7–16, range <2 months to 17 years). Seventy-nine percent of patients had ≥1 comorbid condition. At baseline, 90% of children required supplemental oxygen and 51% required invasive ventilation. By day 28 of follow-up, 88% of patients had a decreased oxygen-support requirement, 83% recovered, and 73% were discharged. Among children requiring invasive ventilation at baseline, 90% were extubated, 80% recovered, and 67% were discharged. There were 4 deaths, of which 3 were attributed to COVID-19. Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to COVID-19 or comorbid conditions. Laboratory abnormalities, including elevations in transaminase levels, were common; 61% were grades 1 or 2. CONCLUSIONS: Among 77 children treated with remdesivir for severe COVID-19, most recovered and the rate of serious adverse events was low.

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Qualitative analysis of a mucoadhesive polymeric (hydroxypropyl methylcellulose, HPMC) suspension of norfloxacin was carried out with the aim of developing an oral controlled release gastro-retentive dosage form. The characterization of ultrasonicated formulation was performed by Fourier Transform Infrared Spectroscopy (FTIR), Raman spectroscopy, X-ray powder diffraction (XRD) and Scanning electron microscopy (SEM) analyses. For interpretation, FTIR (400-4000 cm-1 region) and Raman (140-2400 cm-1 region) spectra were used. XRD data of pure drug, polymer and the mucoadhesive polymeric suspension were obtained using a powder diffractometer, scanned from a Bragg’s angle (2θ) of 10˚ to 70˚. In addition, dispersion of particle was studied using SEM techniques. The results from FTIR and Raman spectroscopic analyses of the mucoadhesive suspension suggested that carboxylic groups of norfloxacin and hydroxyl groups of HPMC undergo chemical interaction leading to esterification and hydrogen bonding. The XRD data indicated the retention of crystalline nature of norfloxacin in the mucoadhesive suspension. Moreover, the SEM image analysis suggested that in the formulation, maximum particles exhibited network like structure to produce pseudoplastic flow. From our analysis, it may be concluded that it is feasible to prepare a homogeneous, uniformly dispersed, pharmaceutically stable controlled release norfloxacin suspension that has better bioavailability and penetration capacity.

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