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Background: SARS-CoV-2 binding to ACE2 is potentially associated with severe pneumonia due to COVID-19. The aim of the study was to test whether Mas-receptor activation by 20-hydroxyecdysone (BIO101) could restore the Renin-Angiotensin System equilibrium and limit the frequency of respiratory failure and mortality in adults hospitalized with severe COVID-19. Methods: Double-blind, randomized, placebo-controlled phase 2/3 trial. Randomization: 1:1 oral BIO101 (350 mg BID) or placebo, up to 28 days or until an endpoint was reached. Primary endpoint: mortality or respiratory failure requiring high-flow oxygen, mechanical ventilation, or extra-corporeal membrane oxygenation. Key secondary endpoint: hospital discharge following recovery (ClinicalTrials.gov Number, NCT04472728). Findings: Due to low recruitment the planned sample size of 310 was not reached and 238 patients were randomized between August 26, 2020 and March 8, 2022. In the modified ITT population (233 patients; 126 BIO101 and 107 placebo), respiratory failure or early death by day 28 was 11.4% lower in the BIO101 (13.5%) than in the placebo (24.3%) group, (p = 0.0426). At day 28, proportions of patients discharged following recovery were 80.1%, and 70.9% in the BIO101 and placebo group respectively, (adjusted difference 11.0%, 95% CI [-0.4%, 22.4%], p = 0.0586). Hazard Ratio for time to death over 90 days: 0.554 (95% CI [0.285, 1.077]), a 44.6% mortality reduction in the BIO101 group (not statistically significant). Treatment emergent adverse events of respiratory failure were more frequent in the placebo group. Interpretation: BIO101 significantly reduced the risk of death or respiratory failure supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. Funding: Biophytis.
RESUMO
BACKGROUND: Binge eating disorder (BED) is now a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). However, post-DSM-5 patient profiles and viewpoints on BED diagnosis and treatment remain unclear. This study used a focus group methodology to examine demographic and clinical characteristics, as well as perceptions of diagnosis and treatment from patients with BED symptoms who were either formally diagnosed with BED or undiagnosed. METHODS: Binge eating disorder-diagnosed individuals (n = 11) or those meeting the DSM-5 BED diagnostic criteria but were undiagnosed (n = 14) participated in 6 semistructured focus groups conducted by trained staff at 3 geographic locations in the United States. Patients completed a series of demographic and clinical measures and then engaged in a moderated discussion focused on identifying factors associated with their experiences with BED. RESULTS: Sixty percent of the patients were female, 48% were white and 40% were black, and 76% were employed. The diagnosed group had a slightly higher socioeconomic status; undiagnosed patients had a higher average body mass index. In the overall sample, comorbid anxiety (40%) and depression (40%) were the most common psychiatric comorbidities. Even in the diagnosed group, only half of the patients (54.5%) became aware of BED through their health care provider (HCP; n = 6). Patients perceived that HCPs were focused more on physical ailments, were judgmental about weight, and were unable to distinguish BED from obesity. They also expressed a desire for safe, nonjudgmental interactions with HCPs. CONCLUSIONS: Education and income may be factors affecting access to care and BED diagnosis. Both patient groups reported considerable psychopathology and medical comorbidities. Moreover, the patient groups perceived HCPs as both having inadequate understanding of BED and providing insensitive and ineffective communication regarding eating behaviors. The study findings in diagnosed and undiagnosed patient groups underscore the need for greater BED disease state awareness and patient sensitivity among HCPs.