ABSTRACT
PURPOSE: To present a case of bilateral acute iris depigmentation after covid 19 infection. CASE REPORT: A 55-year-old female presented with binocular pain and blurred vision a month after being diagnosed with severe acute respiratory syndrome - coronavirus-2 (SARS-CoV-2). She presented pigment dispersion in the anterior chamber and pigment depositions on the corneal endothelium. The patient was treated with dexamethasone and during follow-up visits, the pigment dispersion decreased and the symptoms ceased. CONCLUSIONS: Covid-19 infection may be associated with rare ocular disorders such as BADI.
ABSTRACT
Rationale Asthma is characterized by chronic inflammation;inhaled corticosteroids (ICS) are the preferred antiinflammatory treatment at all severity levels. Velsecorat, a once-daily inhaled non-steroidal selective glucocorticoid receptor (GR) modulator potentially has an improved risk-benefit profile compared to ICS. The aim of this Phase 1 study (AMBER, NCT03976869) was to establish the pharmacokinetic (PK) and pharmacodynamic (PD) profile of velsecorat in adolescents to enable inclusion of this population in phase 3 studies. Necessitating long site visits, PK studies are challenging to conduct in adolescents, disrupt patient school attendance and interfere with the daily lives of the patients' families. In AMBER, we revolutionized the conduct of this type of study by bringing the study directly to the patient's home (Figure 1). Methods This open-label, multi-center study enrolled 36 adolescents (12-17 years) with Global Initiative for Asthma (GINA) step 2 asthma. After a 2-3-week washout of asthma controller, patients received 360μg velsecorat inhaled once-daily for two weeks, with short acting β-agonists allowed as rescue medication. The primary objective was to determine steady state PK;key secondary endpoints were safety and change from baseline in;trough FEV1, plasma cortisol, and asthma control as measured by the asthma control questionnaire-5 (ACQ-5). Study site visits were combined with telemedicine and home nursing visits, as well as collection of daily dairy data via smartphone app. Results Following administration of velsecorat, individual steady state exposure parameters in patients aged 12-14 and 15-17 years were within the same range. Change from baseline in adjusted mean plasma cortisol levels, mean ACQ-5 scores and mean Day15 FEV1 were limited and not clinically significant. Velsecorat was well tolerated, and no new safety concerns were identified. During the COVID-19 pandemic, patient recruitment was accelerated, highlighting that the decentralized design of AMBER, was more suitable for social distancing practices than the traditional site-centric trial model. Participant and caregiver surveys administered at study end revealed that most participants were willing to participate in similar decentralized trials in the future. Conclusions Overall, the results support the advancement of velsecorat into phase 3 studies including adolescents. AMBER offered a convenient and patient-centric study experience for adolescents and their families during the pandemic. Decentralized studies has the potential to become a new standard by offering a flexible convenient, safe and patient-friendly study format for an adolescent population, as shown by the high recruitment and retention rate during the peak of the COVID-19 pandemic.
ABSTRACT
The negative effects of coronavirus disease 2019 (COVID-19) pandemic have impacted the world economy due to the absence from work because of SARS-CoV-2 infection in workers, among other reasons. However, some economic areas are essential to society and people must continue working outside the home to support economic reactivation;their serological profile could be different from that of the global population. Cross-sectional study: Workers from health, construction, public transportation, public force, bike delivery messengers, independent or informal commerce areas, and residents of Bucaramanga or its metropolitan area were invited to participate. All participants self-completed a virtual survey and a blood test was taken to assess IgG and IgM with the ARC COV2 test. Seroprevalence was estimated considering a complex survey design, correcting for a finite population effect and adjusting for test performance. A total of 7045 workers were enrolled;59.9% were women and most were residents of Bucaramanga and working in health occupations. The global adjusted seroprevalence was 19.5% (CI: 95% 18.6-20.4), being higher for Giron (27.9%;95% CI: 24.5-31.30). Workers with multiple contact with people during working hours or using public transportation to go to work had a higher frequency of seropositivity for SARS-CoV-2. The seroprevalence among workers living in these four municipalities from the Colombian northeast area is still low.