ABSTRACT
Background: Omalizumab is an anti-immunoglobulin E monoclonal antibody used to treat moderate to severe chronic idiopathic urticaria, asthma, and nasal polyps. Recent research suggested that omalizumab may enhance the innate antiviral response and have anti-inflammatory properties. Objective: We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for coronavirus disease 2019 (COVID-19) pneumonia. Methods: This was a phase II randomized, double blind, placebo-controlled trial comparing omalizumab with placebo (in addition to standard of care) in hospitalized patients with COVID-19. The primary endpoint was the composite of mechanical ventilation and/or death at day 14. Secondary endpoints included all-cause mortality at day 28, time to clinical improvement, and duration of hospitalization. Results: Of 41 patients recruited, 40 were randomized (20 received the study drug and 20 placebo). The median age of the patients was 74 years and 55.0% were male. Omalizumab was associated with a 92.6% posterior probability of a reduction in mechanical ventilation and death on day 14 with an adjusted odds ratio of 0.11 (95% credible interval 0.002-2.05). Omalizumab was also associated with a 75.9% posterior probability of reduced all-cause mortality on day 28 with an adjusted odds ratio of 0.49 (95% credible interval, 0.06-3.90). No statistically significant differences were found for the time to clinical improvement and duration of hospitalization. Numerically fewer adverse events were reported in the omalizumab group and there were no drug-related serious adverse events. Conclusions: These results suggest that omalizumab could prove protective against death and mechanical ventilation in hospitalized patients with COVID-19. This study could also support the development of a phase III trial program investigating the antiviral and anti-inflammatory effect of omalizumab for severe respiratory viral illnesses requiring hospital admission. ClinicalTrials.gov ID: NCT04720612.
ABSTRACT
Mental practice (MP) using motor imagery is recognized as an effective clinical tool in rehabilitative medicine for improving motor performance. Preliminary data using MP in dysphagia rehabilitation are promising, though nothing is known about the current landscape among speech-language pathologists (SLPs) relating to MP implementation. This nationwide study surveys practicing SLPs about knowledge and practice patterns of using MP to gain a better understanding of the current knowledge, as well as perceived benefits and challenges in using MP. Descriptive data are reported and open-ended questions analyzed for emerging themes using inductive coding. Over half of the participants were familiar or somewhat familiar with motor imagery in the context of dysphagia rehabilitation, though only 16% of those SLPs reported using MP with a patient. Nearly 75% of respondents expressed interest in learning more about MP. Emerging themes include factors SLPs perceive to limit patient engagement, evidence-based practice concerns, and therapeutic environmental factors. More research on MP and access to training for clinicians is needed in the area of dysphagia rehabilitation to address acknowledged interest in MP.
