Use of digital tools in virtual education in Ecuador

Education changes with the passing of time, in the modern age schools and universities emerged, including the teaching given by church professors, until the diversification of classes that could exercise the right to education given by governmental models such as democracy. All these changes transformed several human paradigms, among the recent changes of the contemporary age, we found: secular education, and virtual education, the latter became potentialized thanks to a global event. In the year 2020, humanity faced a critical situation that had not been experienced for more than six centuries, since the emergence of the Black Death in Eurasia in 1347-1353. The Covid-19 pandemic disrupted "normality”, according to the Economic Commission for Latin America and the Caribbean (ECLAC), leading countries to take restrictive protective measures, including the suspension of face-to-face classes in all educational institutions. Thanks to this event, digital tools were essential for the intellectual and economic development of the world, among those used was the e-learning platform that allowed teachers and students to interact with each other. However, there coexisted countless homes in which buying a technological device or hiring internet service was not possible, either because of the economic situation or geographical location, they could not access virtual classes, which led them to make monetary sacrifices such as: loans or mobilizing to places where the signal could reach. © 2022, Associacao Iberica de Sistemas e Tecnologias de Informacao. All rights reserved.

Safety, Tolerability, and Viral Pharmacodynamics of the IgG Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection for the Treatment of Early Mild-to-Moderate COVID-19

Background. There is a continued need for therapeutics for the treatment of COVID-19, including intramuscular (IM) agents, which will enable broader use across a variety of healthcare delivery settings. Methods. COMET-PEAK (NCT04779879) is a 3-part study evaluating the safety, tolerability, pharmacokinetics (Part A), and viral pharmacodynamics (PD) of sotrovimab as treatment in adults >= 18 years with early mild/moderate COVID-19. In Parts B and C, the safety, tolerability and viral PD of sotrovimab administered as a 500 mg intravenous (IV) infusion or as a 500 mg or 250 mg IM injection, respectively, was evaluated. The primary objective for Parts B and C was to compare the virologic response of sotrovimab IM to IV, with an endpoint of mean area under the curve (AUC) of SARS-CoV-2 viral load as measured by qRT-PCR from Day 1 to Day 8 (AUCD1-8) in nasopharyngeal swabs and predefined 90% confidence interval (CI) limits of 0.5-2.0 indicating equivalence. Results. A total of 167 and 157 participants were enrolled in Part B and C, respectively, from February-July 2021. The median age of participants was 47 and 42 years in Part B and C, respectively, and ~50% had >= 1 risk factor for progression to severe disease. The viral load at baseline and through Day 29 of follow-up for each arm is shown in Table 1 and Figure 1. The primary objective was met for both study parts: the ratio of the least square geometric mean viral load AUC(D1-8) of sotrovimab IM vs IV was 1.04 (90% CI, 0.98, 1.09) and 1.02 (90% CI, 0.94, 1.11), for Part B and C, respectively. Through Day 29 of follow-up, the most common adverse event was injection site reactions (ISRs) in the IM arms. A total of 10 (12%) participants in the 500 mg IM group and 4 (5%) participants in the 250 mg IM group experienced an ISR, all Grade 1. Serious adverse events were uncommon, and related to COVID-19 progression, including one death in the 250 mg IM arm (Table 2). ISRs aside, there were few treatment-related AEs (2/84 IV, 1/82 IM) in Part B, none serious. Conclusion. IM administration of sotrovimab 500 mg and 250 mg each demonstrated equivalence to 500 mg sotrovimab IV in viral load assessments. Overall, there were no treatment-related serious AEs and sotrovimab was well tolerated. An 500 mg IM formulation will allow for expanded treatment potential with sotrovimab.

Machine learning models to characterize the cough signal of patients with COVID-19

Automatic recognition of audio signals is a challenging signal task due to the difficulty of extracting important attributes from such signals, which relies heavily on discriminating acoustic features to determine the type of cough audio coming from COVID-19 patients. In this work, the use of state-of-the-art pre-trained models and a convolutional neural network for the extraction of characteristics of a cough signal from patients with COVID-19 is analyzed. A comparison of three machine learning models has been proposed to extract the features containing relevant information, leading to the recognition of the COVID-19 cough signal. The first model is based on a basic convolutional neural network, the second is based on a YAMNet pre-treatment model, and the third is a VGGish pre-trained model. The experimental results carried out with a ComPare 2021 CCS database show that models, of the three, used, VGGish to provide better performance when extracting the characteristics of the audio signals of the COVID-19 cough signal, having as results the performance metrics f1 score and accuracy with values of 30.76% and 80.51%, representing an improvement of 6.06% and 3.61% compared to the YANMet model, and the confusion matrices, which validate the mentioned model. © 2022 Latin American and Caribbean Consortium of Engineering Institutions. All rights reserved.

INTRAMUSCULAR SOTROVIMAB IS NONINFERIOR to INTRAVENOUS SOTROVIMAB for COVID-19

Background: Sotrovimab is a pan-sarbecovirus neutralizing monoclonal antibody shown to be safe and effective for the treatment of early COVID-19 in high-risk patients and retains activity against variants of concern, including delta and omicron. To facilitate wider access to sotrovimab, it was formulated to allow for either intramuscular (IM) or intravenous (IV) administration. Methods: COMET-TAIL (NCT04913675) is a Phase III, randomized, multicenter, open-label, noninferiority (NI) study of IM vs IV sotrovimab for the treatment of mild/moderate COVID-19 in participants ≥12 years of age at high risk of disease progression. Participants were randomized to receive sotrovimab by single 500 mg IV infusion or IM injection (500 mg or 250 mg). The primary objective was to evaluate the efficacy of 500 mg IM vs 500 mg IV sotrovimab in preventing hospitalization for >24 hours for acute management of illness due to any cause or death. The 250 mg IM arm discontinued early due to a greater number of hospitalizations seen in that arm. A 3.5% NI margin on the risk difference scale was prespecified. Results: COMET-TAIL enrollment occurred from Jun-Aug 2021, coinciding with a surge in the SARS-CoV-2 delta variant in southern USA. The majority (∼85%) of participants were Hispanic or Latino and ∼25% were ≥65 years of age. In the 500 mg IM sotrovimab arm, 10/376 (2.7%) participants compared with 5/378 (1.3%) in the sotrovimab 500 mg IV arm met progression criteria for the primary endpoint (adjusted risk difference: 1.07% [95% CI:-1.25%, 3.39%]), meeting the NI margin of 3.5%. The overall rate of adverse events and injection/infusion-related reactions was low and similar between the 500 mg treatment arms. Most injection-site reactions were mild (grade 1), occurred shortly after dosing, and were limited in duration. Disease-related events (DREs) were balanced between the 500 mg IV and 500 mg IM arms. The most frequent DREs were COVID-19 pneumonia and pneumonia. There was a low percentage of participants (∼1%) with serious adverse events across all treatment arms, and none were considered related to treatment. Two participants (1 with BMI 69 mg/kg2 and an 82-year-old man) in the 500 mg IM arm died due to progression of COVID-19;no deaths occurred in the 500 mg IV arm. Conclusion: In the COMET-TAIL trial, sotrovimab given by 500 mg IM injection was found to be noninferior to IV infusion and was well tolerated. The option of IM administration will expand the potential for outpatient treatment with sotrovimab.

Early COVID-19 Treatment with SARS-CoV-2 Neutralizing Antibody Sotrovimab

Background. COVID-19 disproportionately results in hospitalization and death in older patients and those with underlying comorbidities. Sotrovimab is a pan-sarbecovirus monoclonal antibody that binds a highly conserved epitope of the SARSCoV-2 receptor binding domain and has an Fc modification that increases half-life. Sotrovimab retains activity against UK, S. Africa, Brazil, India, New York and California variants in vitro. Objectives. To evaluate the efficacy and safety of treatment with sotrovimab in high-risk, non-hospitalized patients with mild/moderate COVID-19, as part of the COMET-ICE clinical trial. Methods. Multicenter, double-blind, phase 3 trial in non-hospitalized patients with symptomatic COVID-19 and ≥1 risk factor for disease progression were randomized 1:1 to an IV infusion of sotrovimab 500 mg or placebo. The primary efficacy endpoint was the proportion of patients with COVID-19 progression, defined as hospitalization > 24 hours or death, due to any cause, ≤29 days of randomization. Results. The study met the pre-defined primary efficacy endpoint in a preplanned interim analysis: the risk of COVID-19 progression was significantly reduced by 85% (97.24% CI, 44% to 96%;P = 0.002) in 583 patients. In the final intention-to-treat analysis (N = 1057), the adjusted relative risk reduction was 79% (95% CI, 50% to 91%;p< 0.001) through Day 29 in recipients of sotrovimab (n=528) vs. placebo (n=529). Treatment with sotrovimab (ITT) resulted in a numerical reduction in the need for ER visits for illness management, hospitalization for acute illness management (any duration) or death (any cause) compared to placebo. No participants on sotrovimab required ICU admission, compared to 9 participants on placebo, of whom 4 participants required mechanical ventilation. No participants who received sotrovimab died, compared to 4 participants on placebo. The incidence of adverse events was similar between treatment arms and SAEs were numerically more common in the placebo arm. Conclusion. Treatment with sotrovimab 500 mg IV resulted in a clinically and statistically significant reduction in progression of COVID-19 to hospitalization or death in patients with mild/moderate disease and was well-tolerated.

What happened to infectious diseases and anti-infective therapy in 2020 beyond COVID-19?

The year 2020 was the year of infectious diseases with the arrival of SARS-CoV-2, which represented a profound change in the world we knew. However, we present a brief description of some of the top infectious diseases articles from 2020 not related with SARS-CoV-2. We reviewed a selection of the most important and relevant achievements in diagnosis and therapy related to bacteremia, nosocomial pneumonia, skin and soft tissue infections, infections by Clostridioides difficile, mycobacterial infections and invasive fungal infections. This year entailed a significant step forward in the indisputable value of the health care stewardship programs.