SAFETY of REMDESIVIR VS PLACEBO in NONHOSPITALIZED PATIENTS with COVID-19

Background: Remdesivir (RDV), a potent nucleotide inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase, effectively reduces COVID-19 related hospitalization in outpatients at high risk for progression to severe disease. However, limited data exist on the safety profile of RDV in this population. Methods: We conducted a Phase III placebo-controlled study evaluating a 3-day regimen of RDV in non-hospitalized patients who are at risk for disease progression (age>60 years or underlying comorbid condition). Patients were randomly assigned 1:1 to receive intravenous RDV (200 mg on day 1, 100 mg on days 2 to 3) or placebo (PBO). The primary safety endpoint was the proportion of patients with treatment-emergent adverse events (AEs). AEs were evaluated through day 28 and lab abnormalities were evaluated through day 14. Results: 562 patients were randomized and initiated treatment (279, RDV;283, placebo). Baseline characteristics were balanced between groups. Thirty percent were ≥60 years old and most common comorbidities were diabetes mellitus (62%), obesity (56%;median BMI, 30.7 kg/m2), and hypertension (48%). RDV was well tolerated with a similar rate of any AEs between groups (Table). Patients treated with RDV had fewer Grade ≥3 and serious AEs (SAEs) compared to PBO, but had more study-drug related AEs, with the most common one being nausea (18 [6.5%] in RDV vs. 10 [3.5%] in PBO). Grade 3 or higher ALT elevation was reported in 1 (0.4%) RDV vs. 2 (0.7%) PBO treated patients. Median change from baseline in AST, ALT, and bilirubin was similar between groups (Table). Grade 3 or higher decrease in creatinine clearance (CrCl) occurred more often in RDV vs. to PBO treated patients (5.6% vs 1.9% respectively). Most decreases in creatinine clearance occurred within the normal serum creatinine range, occurred after completion of RDV therapy, and resolved on follow-up. Median changes in CrCl from baseline were similar between groups and no renal AEs were reported (Table). Incidence of cardiac-related AEs was similar between RDV and PBO groups. All bradycardia events occurred in the PBO group. No patient experienced a serious AE or drug discontinuation due to hypersensitivity. Conclusion: Treatment with RDV was safe and well tolerated in non-hospitalized patients with risk factors for COVID-19 disease progression. Patients in the RDV group had similar type, incidence, and severity of AEs and lab abnormalities as those receiving PBO.

Remdesivir for the Treatment of High-Risk Non-Hospitalized Individuals with COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial

Background. Remdesivir (RDV) is a potent nucleotide prodrug inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase that has demonstrated efficacy in the treatment of patients hospitalized with moderate to severe COVID-19. This Phase 3 (GS-US-540-9012) double-blind, placebo-controlled study compared the efficacy and safety of 3 days of RDV to standard of care in non-hospitalized, high-risk participants with confirmed COVID-19. Methods. Participants were randomly assigned 1:1 to receive intravenous (IV) RDV (200 mg on day 1, 100 mg on days 2 to 3) or placebo. The primary efficacy endpoint was composite COVID-19 hospitalization or all-cause death by day 28 and compared using Cox proportional hazards model with baseline stratification factors as covariates. The primary safety endpoint was proportion of participants with treatment-emergent adverse events. Study enrollment was terminated early for administrative reasons in light of the evolving pandemic. Results. 562 patients underwent randomization and started their assigned treatment (279, RDV;283, placebo). Baseline demographics and characteristics were balanced across arms. Overall, 52% were male, 44% were Hispanic/Latino ethnicity and 30% were ≥ 60 years old. The most common comorbidities were diabetes mellitus (62%), obesity (56%;median BMI, 30.7), and hypertension (48%). Median baseline SARS-CoV-2 RNA nasopharyngeal viral load was 6.2 log10 copies/mL. Treatment with RDV significantly reduced COVID-19 hospitalization or all-cause death by day 28 (HR, 0.13;95% CI, 0.03 - 0.59;p = 0.008;Table 1) compared to placebo. Participants receiving RDV also had significantly lower risk for COVID-19-related medically attended visits or all-cause death by day 28 compared to placebo (HR, 0.19;95% CI, 0.07 - 0.56;p = 0.002;Table 1). No deaths occurred in either arm by day 28. There was no difference between arms in time-weighted average change in nasopharyngeal viral loads from baseline up to day 7. The proportion of patients with AEs was similar between arms (Table 1);the most common AEs in the RDV arm were nausea (11%), headache (6%), and diarrhea (4%). Conclusion. A 3-day course of IV RDV was safe, well tolerated and highly effective at preventing COVID-19 related hospitalization or death in high-risk non-hospitalized COVID-19 patients.

TInformative treatment and media competencies on COVID-19 in Ecuador

Information overload, misinformation and false news have led to the need to strengthen media literacy. With the global health emergency decree produced by the appearance of CoViD-19, users of traditional and digital media are in a constant search for information on the subject. This study analyzes the communication practices of media users and their perception of the information they receive about the coronavirus. To this end, quantitative research was done with the help of a self-administered questionnaire to a total of 2,090 Ecuadorians. In addition, use is made of the technique of reverse engineering of data to analyze the topics and traditional and digital platforms that citizens frequently access to get information. The results indicate that there is a preference for the information published on Web 2.0 platforms: topics related to health guidelines and a possible vaccine to face the disease. Also, a loss of confidence in traditional media and government sources is identified, while citizens give greater credibility to news shared by friends and family. Therefore, it is concluded that it is necessary to develop strategies focused on the diversity of social groups. This can be done by working among health organisms, scientists from Ecuadorian universities, media (traditional - digital) and citizen participation (prosumer) through interactive communicational proposals. These will make it possible to counteract the infodemic through media literacy and digital responsibility to position information based on scientific evidence.

Informative treatment and media competencies on COVID-19 in Ecuador

Information overload, misinformation and false news have led to the need to strengthen media literacy. With the global health emergency decree produced by the appearance of CoViD-19, users of traditional and digital media are in a constant search for information on the subject. This study analyzes the communication practices of media users and their perception of the information they receive about the coronavirus. To this end, quantitative research was done with the help of a self-administered questionnaire to a total of 2,090 Ecuadorians. In addition, use is made of the technique of reverse engineering of data to analyze the topics and traditional and digital platforms that citizens frequently access to get information. The results indicate that there is a preference for the information published on Web 2.0 platforms: topics related to health guidelines and a possible vaccine to face the disease. Also, a loss of confidence in traditional media and government sources is identified, while citizens give greater credibility to news shared by friends and family. Therefore, it is concluded that it is necessary to develop strategies focused on the diversity of social groups. This can be done by working among health organisms, scientists from Ecuadorian universities, media (traditional - digital) and citizen participation (prosumer) through interactive communicational proposals. These will make it possible to counteract the infodemic through media literacy and digital responsibility to position information based on scientific evidence. (English) [ABSTRACT FROM AUTHOR] La sobresaturación informativa, desinformación y noticias falsas ha propiciado la necesidad de reforzar la alfabetización mediática. Con el decreto de emergencia sanitaria mundial producido por la aparición del CoViD-19, los usuarios de medios tradicionales y digitales se encuentran en una búsqueda informativa constante sobre el tema. El presente estudio analiza las prácticas comunicativas de los usuarios de los medios de comunicación y su percepción en torno a la información que reciben sobre el coronavirus. Para ello, se ha realizado una investigación cuantitativa con ayuda de un cuestionario autoadministrado a un total de 2.090 ecuatorianos. Además, se hace uso de la técnica de ingeniería inversa de datos para analizar las temáticas y plataformas tradicionales y digitales a las que frecuentemente accede la ciudadanía para informarse. Los resultados indican que existe una preferencia por la información publicada en plataformas de la Web 2.0: referencias a directrices sanitarias y una posible vacuna para enfrentar la enfermedad. También, se identifica una pérdida de confianza en los medios de comunicación tradicionales y en las fuentes gubernamentales, en tanto que la ciudadanía le da mayor credibilidad a las noticias compartidas por amigos y familiares. Por tanto, se concluye que es necesario desarrollar estrategias focalizadas a la diversidad de grupos sociales. Esto se puede llevar a cabo mediante un trabajo articulado entre los organismos de salud, científicos de las universidades ecuatorianas, medios de comunicación (tradicionales - digitales) y la participación ciudadana (prosumer) por medio de propuestas comunicacionales interactivas. Estos permitirán contrarrestar la infodemia mediante la alfabetización mediática y la responsabilidad digital para posicionar la información basada en evidencia científica. (Spanish) [ABSTRACT FROM AUTHOR] Copyright of Revista de Comunicación is the property of Revista de Comunicacion-Universidad de Piura and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Spanish Society of Cardiovascular and Endovascular surgery recommendations for the COVID-19 pandemia

In the actual COVID-19 pandemic, the Spanish Society of Cardiovascular and Endovascular Surgery (SECCE) assumes the obligation to elaborate special recommendations that ensure an adequate health care of population, while minimizing the exposure and the risk of contagion for both patients and professionals. For that reason, Cardiovascular Surgery Departments need to develop a functional plan of contingency within the global framework formulated by the instructions of the Ministry of Health and hospital authorities. The aim of this strategy is the proper functioning of Cardiovascular Surgery Departments: a) Correct care for urgent and emerging patients. b) The preparation of a list of preferred patients and temporary treatment criteria. c) The justified and safe delay of elective patients if their pathology and clinical situation allow it. d) The concrete application of ECMO programs in the COVID-19 context.