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Background The prevention of coronavirus disease 2019 (COVID-19) in vulnerable populations is a global health priority. EVADE was a phase 2/3 multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended–half-life monoclonal antibody, for postexposure (PEP) and pre-exposure prophylaxis (PrEP) of symptomatic COVID-19. Methods Eligible participants (vaccine-naive, aged ≥12 years) were randomized 1:1 to receive a single 300-mg intramuscular injection of adintrevimab or placebo. Primary efficacy end points were reverse transcription polymerase chain reaction (RT-PCR)–confirmed symptomatic COVID-19 through day 28 in the PEP cohort (RT-PCR-negative at baseline) and through month 3 in the PrEP cohort (RT-PCR-negative and seronegative at baseline) among participants randomized before emergence of the severe acute respiratory syndrome coronavirus 2 Omicron variant (November 30, 2021). Safety was assessed through 6 months. Results Between April 27, 2021, and January 11, 2022, 2582 participants were randomized. In the primary efficacy analysis, RT-PCR-confirmed symptomatic COVID-19 occurred in 3/175 (1.7%) vs 12/176 (6.8%) adintrevimab- and placebo-treated PEP participants, respectively (74.9% relative risk reduction [RRR]; standardized risk difference, −5.0%; 95% CI, −8.87% to −1.08%; P =.0123) and in 12/752 (1.6%) vs 40/728 (5.5%) adintrevimab- and placebo-treated PrEP participants, respectively (71.0% RRR; standardized risk difference, −3.9%; 95% CI, −5.75% to −2.01%; P <.0001). In a prespecified exploratory analysis of 428 PrEP participants randomized after the emergence of Omicron, adintrevimab reduced RT-PCR-confirmed symptomatic COVID-19 by 40.6% (standardized risk difference −8.4%; 95% CI, −15.35% to −1.46%; nominal P =.0177) vs placebo. Adintrevimab was well tolerated, with no serious drug-related adverse events reported. Conclusions A single intramuscular injection of adintrevimab provided prophylactic efficacy against COVID-19 due to susceptible variants without safety concerns. Clinical trial registration. NCT04859517. [ABSTRACT FROM AUTHOR]

Background Safe and effective treatments are needed to prevent severe outcomes in individuals with coronavirus disease 2019 (COVID-19). We report results from STAMP, a phase 2/3, multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended half-life monoclonal antibody, for treatment of high-risk ambulatory patients with mild to moderate COVID-19. Methods Nonhospitalized, unvaccinated participants aged ≥12 years with mild to moderate COVID-19 and ≥1 risk factor for disease progression were randomized to receive a single intramuscular injection of 300 mg adintrevimab or placebo. Enrollment was paused due to the global emergence of the Omicron BA.1/BA1.1 variants, against which adintrevimab showed reduced activity in vitro. The primary efficacy endpoint was COVID-19–related hospitalization or all-cause death through day 29 in participants with COVID-19 due to laboratory-confirmed or suspected non-Omicron severe acute respiratory syndrome coronavirus 2 variants. Results Between 8 August 2021 and 11 January 2022, 399 participants were randomized to receive adintrevimab (n = 198) or placebo (n = 201), including 336 with COVID-19 due to non-Omicron variants. COVID-19–related hospitalization or all-cause death through day 29 occurred in 8 of 169 (4.7%) participants in the adintrevimab group and 23 of 167 (13.8%) participants in the placebo group, a 66% relative risk reduction in favor of adintrevimab (standardized risk difference, −8.7% [95% confidence interval, −14.71% to −2.67%]; P =.0047). Incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups (33.9% for adintrevimab and 39.5% for placebo). No adintrevimab-related serious TEAEs were reported. Conclusions Treatment with a single intramuscular injection of adintrevimab provided protection against severe outcomes in high-risk ambulatory participants with COVID-19 due to susceptible variants, without safety concerns. Clinical Trial Registration. NCT04805671. [ABSTRACT FROM AUTHOR]

[english] The development of digital media has been impressive in recent years which is also among the reason for their increasing use in academic teaching.This is especially true for teaching Anatomy and Histology in the first two years in medical and dental curricula. Modern digital technologies allow for efficient, affordable and easily accessible distribution of histological images in high quality. Microscopy depends almost exclusively on such images. Since 20 years numerous digital teaching systems have been developed for this purpose. Respective developments have changed the ways students acquire knowledge and prepare for exams. Teaching staff should adapt lectures, seminars and labs accordingly. As a first step, a collection of high resolution digital microscopic slides was made available for students at the Friedrich-Schiller-University in Jena. The aim of the present study was to evaluate the importance of conventional light microscopy and related technologies in current and future medical and dental education aswell. A survey was done among 172 medical and dental students at the Friedrich-Schiller-University Jena. 51% of students use now frequently new digital media for learning histology in contrast to 5% in the year 2000 . Digital media including Internet, CD- based learning combined with social networks successfully compete with classical light microscopy.[german] Die Entwicklung digitaler Medien wuchs in jüngster Zeit beträchtlich an, was mitunter als Ursache für deren wachsende Nutzung in der universitären Lehre anzusehen ist. Zutreffend ist dies insbesondere auch im Bereich der Anatomie und Histologie, welche Bestandteile des Studiums für Ärzte und Zahnärzte in den ersten zwei Studienjahren darstellen. Moderne digitale Technologien erlauben es eine leistungsfähige, bezahlbare und begreifbare Verbreitung histologischer Bilder in hoher Qualität zu gewährleisten. Die Mikroskopie hängt fast ausschließlich von Bildern ab. Seit 20 Jahren werden somit stetig neue virtuelle Lernprogramme auch für die Histologie entwickelt. Entsprechende Entwicklungen haben dadurch die Lernmethoden der Studenten zum Wissenserwerb und zur Prüfungsvorbereitung beeinflusst. Die Lehre sollte Seminare, Vorlesungen und Laborarbeiten dementsprechend anpassen. Als einen ersten Schritt wurde eine Sammlung digitaler mikroskopisch-histologischer Bilder für die Studenten an der FSU Jena zur Verfügung gestellt. Das Ziel dieser Studie ist es den Stellenwert des konventionellen Lichtmikroskops im derzeitigen Selbststudium der Studenten der Human- und Zahnmedizin im Vergleich zu digitalen Medien herauszufinden. Dazu wurde eine Umfrage unter 172 Human- und Zahnmedizinstudenten an der Friedrich-Schiller-Universität Jena durchgeführt. Die Ergebnisse lassen einen deutlichen Unterschied mit 51% Nutzung neuer Medien gegenüber früheren ähnlichen Studien mit 5% Nutzung erkennen. Es zeigt, dass digitale Medien wie Internet und CD- oder computergestützte Lernprogramme sich beim Selbststudium der Studenten der Human- und Zahnmedizin als ein Konkurrenzsystem zum klassischen Lichtmikroskop entwickelten.