Controversy on the CONVINCE study findings: the PRO take / Controvérsia sobre os achados do estudo CONVINCE: a perspectiva PRO

ABSTRACT The CONVINCE study, recently published in the New England Journal of Medicine, reveals a groundbreaking 23% reduction in the relative risk of all-cause mortality among end-stage kidney patients undergoing high convective volume hemodiafiltration. This significant finding challenges the conventional use of high-flux hemodialysis and offers hope for improving outcomes in chronic kidney disease patients. While some controversies surround the study's findings, including concerns about generalizability and the causes of death, it is essential to acknowledge the study's design and its main outcomes. The CONVINCE study, part of the HORIZON 2020 project, enrolled 1360 patients and demonstrated the superiority of hemodiafiltration in reducing all-cause mortality overall, as well as in specific patient subgroups (elderly, short vintage, non-diabetic, and those without cardiac issues). Interestingly, it was shown that hemodiafiltration had a protective effect against infection, including COVID-19. Future research will address sustainability, dose scaling effects, identification of subgroups especially likely to benefit and cost-effectiveness. However, for now, the findings strongly support a broader adoption of hemodiafiltration in renal replacement therapy, marking a significant advancement in the field.

RESUMO O estudo CONVINCE, publicado recentemente no New England Journal of Medicine, revela uma redução inovadora de 23% no risco relativo de mortalidade por todas as causas entre pacientes renais em estágio terminal submetidos à hemodiafiltração de alto volume de convecção. Esse achado significativo desafia o uso convencional da hemodiálise de alto fluxo e oferece esperança de melhoria dos desfechos em pacientes com doença renal crônica. Embora algumas controvérsias cerquem os achados do estudo, incluindo preocupações sobre a generalização e as causas de óbito, é essencial reconhecer o desenho do estudo e seus principais desfechos. O estudo CONVINCE, parte do projeto HORIZON 2020, inscreveu 1.360 pacientes e demonstrou a superioridade da hemodiafiltração na redução da mortalidade por todas as causas em geral, bem como em subgrupos específicos de pacientes (idosos, HD de curta duração, não diabéticos e aqueles sem problemas cardíacos). Curiosamente, demonstrou-se que a hemodiafiltração teve um efeito protetor contra infecções, incluindo a COVID-19. Pesquisas futuras abordarão sustentabilidade, efeitos de escalonamento da dose, identificação de subgrupos especialmente propensos a se beneficiar e a relação custo-benefício. No entanto, por ora, os achados apoiam fortemente uma adoção mais ampla da hemodiafiltração na terapia renal substitutiva, marcando um avanço significativo na área.

Risk factors for acute kidney injury in patients hospitalized with COVID-19 / Fatores de risco para lesão renal aguda em pacientes hospitalizados com COVID-19

Abstract Introduction: Acute kidney injury (AKI) occurs frequently in COVID-19 patients and is associated with greater morbidity and mortality. Knowing the risks of AKI allows for identification, prevention, and timely treatment. This study aimed to identify the risk factors associated with AKI in hospitalized patients. Methods: A descriptive, retrospective, cross-sectional, and analytical component study of adult patients hospitalized with COVID-19 from March 1 to December 31, 2020 was carried out. AKI was defined by the creatinine criteria of the KDIGO-AKI guidelines. Information, regarding risk factors, was obtained from electronic medical records. Results: Out of the 934 patients, 42.93% developed AKI, 60.59% KDIGO-1, and 9.9% required renal replacement therapy. Patients with AKI had longer hospital stay, higher mortality, and required more intensive care unit (ICU) admission, mechanical ventilation, and vasopressor support. Multivariate analysis showed that age (OR 1.03; 95% CI 1.02-1.04), male sex (OR 2.13; 95% CI 1.49-3.04), diabetes mellitus (DM) (OR 1.55; 95% CI 1.04-2.32), chronic kidney disease (CKD) (OR 2.07; 95% CI 1.06-4.04), C-reactive protein (CRP) (OR 1.02; 95% CI 1.00-1.03), ICU admission (OR 1.81; 95% CI 1.04-3.16), and vasopressor support (OR 7.46; 95% CI 3.34-16.64) were risk factors for AKI, and that bicarbonate (OR 0.89; 95% CI 0.84-0.94) and partial pressure arterial oxygen/inspired oxygen fraction index (OR 0.99; 95% CI 0.98-0.99) could be protective factors. Conclusions: A high frequency of AKI was documented in COVID-19 patients, with several predictors: age, male sex, DM, CKD, CRP, ICU admission, and vasopressor support. AKI occurred more frequently in patients with higher disease severity and was associated with higher mortality and worse outcomes.

RESUMO Introdução: Lesão renal aguda (LRA) ocorre frequentemente em pacientes com COVID-19 e associa-se a maior morbidade e mortalidade. Conhecer riscos da LRA permite a identificação, prevenção e tratamento oportuno. Este estudo teve como objetivo identificar fatores de risco associados à LRA em pacientes hospitalizados. Métodos: Realizou-se estudo descritivo, retrospectivo, transversal e de componente analítico de pacientes adultos hospitalizados com COVID-19 de 1º de março a 31 de dezembro, 2020. Definiu-se a LRA pelos critérios de creatinina das diretrizes KDIGO-LRA. Informações sobre fatores de risco foram obtidas de prontuários eletrônicos. Resultados: Dos 934 pacientes, 42,93% desenvolveram LRA, 60,59% KDIGO-1 e 9,9% necessitaram de terapia renal substitutiva. Pacientes com LRA apresentaram maior tempo de internação, maior mortalidade e necessitaram de mais internações em UTIs, ventilação mecânica e suporte vasopressor. A análise multivariada mostrou que idade (OR 1,03; IC 95% 1,02-1,04), sexo masculino (OR 2,13; IC 95% 1,49-3,04), diabetes mellitus (DM) (OR 1,55; IC 95% 1,04-2,32), doença renal crônica (DRC) (OR 2,07; IC 95% 1,06-4,04), proteína C reativa (PCR) (OR 1,02; IC 95% 1,00-1,03), admissão em UTI (OR 1,81; IC 95% 1,04-3,16) e suporte vasopressor (OR 7,46; IC 95% 3,34-16,64) foram fatores de risco para LRA, e que bicarbonato (OR 0,89; IC 95% 0,84-0,94) e índice de pressão parcial de oxigênio arterial/fração inspirada de oxigênio (OR 0,99; IC 95% 0,98-0,99) poderiam ser fatores de proteção. Conclusões: Documentou-se alta frequência de LRA em pacientes com COVID-19, com diversos preditores: idade, sexo masculino, DM, DRC, PCR, admissão em UTI e suporte vasopressor. LRA ocorreu mais frequentemente em pacientes com maior gravidade da doença e associou-se a maior mortalidade e piores desfechos.

Brazilian Dialysis Survey 2022 / Censo Brasileiro de Diálise 2022

Abstract Introduction: The Brazilian Dialysis Survey (BDS) is an annual national survey about patients on chronic dialysis that contributes to health policies. Objective: To report the 2022 epidemiological data from the BDS of the Brazilian Society of Nephrology (BSN). Methods: A survey was carried out in Brazilian chronic dialysis centers using an online questionnaire that included clinical and epidemiological aspects of patients on chronic dialysis, dialysis therapy data, and dialysis center characteristics. Results: Overall, 28% (n = 243) of the centers answered the questionnaire. In July 2022, the estimated total number of patients on dialysis was 153,831. The estimated prevalence and incidence rates of patients per million population (pmp) were 758 and 214, respectively. Of the prevalent patients, 95.3% were on hemodialysis (HD, 4.6% of these on hemodiafiltration) and 4.7% on peritoneal dialysis (PD). Only 1.3% of patients were not vaccinated against COVID-19. The prevalence of anemia (Hb < 10g/dL) was 27% and hyperphosphatemia (P > 5.5mg/dL) reached 30%. The estimated overall crude annual mortality rate was 17.1%. Conclusions: The absolute number and prevalence rate of patients on chronic dialysis continue to increase. A growing number of patients were receiving hemodiafiltration. The mortality rate decreased, probably due to the end of COVID-19 pandemic. The conclusions were drawn in the context of relatively low voluntary participation, which imposed methodological limitations on our estimates.

Resumo Introdução: O Censo Brasileiro de Diálise (CBD) é uma pesquisa nacional anual sobre pacientes em diálise crônica que contribui para as políticas de saúde. Objetivo: Informar os dados epidemiológicos de 2022 do CBD da Sociedade Brasileira de Nefrologia (SBN). Métodos: Foi realizada uma pesquisa em centros brasileiros de diálise por meio de um questionário online que incluiu aspectos clínicos e epidemiológicos de pacientes em diálise crônica, dados da terapia dialítica e características do centro de diálise. Resultados: No total, 28% (n = 243) dos centros de diálise ativos cadastrados na SBN responderam ao questionário. Em julho de 2022, o número total estimado de pacientes em diálise era de 153.831. As taxas estimadas de prevalência e incidência de pacientes por milhão (ppm) de habitantes foram 758 e 214, respectivamente. Dos pacientes prevalentes, 95,3% estavam em hemodiálise (HD; 4,6% desses em hemodiafiltração) e 4,7% em diálise peritoneal (DP). Apenas 1,3% dos pacientes não foram vacinados contra a COVID-19. A prevalência de anemia (Hb < 10g/dL) foi de 27% e de hiperfosfatemia (P > 5,5mg/dL) alcançou 30%. A taxa bruta total anual de mortalidade estimada foi de 17,1%. Conclusões: O número absoluto e a taxa de prevalência de pacientes em diálise crônica continuam a aumentar. Um número crescente de pacientes estava em hemodiafiltração. A taxa de mortalidade diminuiu, provavelmente devido ao fim da pandemia da COVID-19. As conclusões foram de um contexto de participação voluntária relativamente baixa, o que impõe limitações metodológicas às nossas estimativas.

Artificial Neural Network Prediction of COVID-19 Daily Infection Count.

This study addresses COVID-19 testing as a nonlinear sampling problem, aiming to uncover the dependence of the true infection count in the population on COVID-19 testing metrics such as testing volume and positivity rates. Employing an artificial neural network, we explore the relationship among daily confirmed case counts, testing data, population statistics, and the actual daily case count. The trained artificial neural network undergoes testing in in-sample, out-of-sample, and several hypothetical scenarios. A substantial focus of this paper lies in the estimation of the daily true case count, which serves as the output set of our training process. To achieve this, we implement a regularized backcasting technique that utilize death counts and the infection fatality ratio (IFR), as the death statistics and serological surveys (providing the IFR) as more reliable COVID-19 data sources. Addressing the impact of factors such as age distribution, vaccination, and emerging variants on the IFR time series is a pivotal aspect of our analysis. We expect our study to enhance our understanding of the genuine implications of the COVID-19 pandemic, subsequently benefiting mitigation strategies.

Efficacy and Safety of Oral and IV Levonadifloxacin Therapy in Management of Bacterial Infections: Findings of a Prospective, Observational, Multi-center, Post-marketing Surveillance Study.

Background Antimicrobial resistance by bacteria poses a substantial threat to morbidity and mortality worldwide, and treatment of resistant infections is a challenge for the treating clinician. Levonadifloxacin is a novel broad-spectrum agent belonging to the benzoquinolizine subclass of quinolone, which can be used by both oral and intravenous administration for the treatment of infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data from 1266 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of various bacterial infections. The duration of the study was 18 months. Study outcomes were clinical success and microbial success at the end of therapy. Global assessments were done for safety and efficacy at the end of therapy using a 5-point Likert scale (excellent, very good, good, satisfactory, and poor). Results The mean (median) duration of therapy was 7.2 (7.0) days, with a median time to clinical improvement of four days. Oral therapy was administered to 224 patients; 940 received IV, and 102 received IV followed by oral therapy. Patients were prescribed levonadifloxacin for gram-positive infections, skin and soft tissue infections, diabetic foot infections, septicemia, catheter-related blood-stream infections, bone and joint infections, febrile neutropenia, and respiratory infections, including COVID-19 pneumonia. The clinical cure on the eighth day was 95.7%, whereas the microbial success on the eighth day was 93.3% (n=60). For different types of infections, the clinical success rates ranged from 85.2% to 100%. There were only 30 treatment-emergent adverse events reported in 29 patients. Overall, about 95.6% of patients rated the efficacy as good to excellent, whereas only 3.8% of patients rated it satisfactory; for safety, 95.7% of patients rated it as good to excellent, with only 3.9% of patients rated it as satisfactory. Conclusions The excellent safety and efficacy profile of levonadifloxacin, when administered as an oral or intravenous therapy, makes it a desirable treatment modality for the management of various bacterial infections, including those caused by resistant pathogens such as MRSA and quinolone-resistant Staphylococcus aureus (QRSA). Features of levonadifloxacin, such as availability in both IV and oral form, minimal drug-drug interactions, lack of the need to adjust dosages in renal and hepatically impaired patients along with a broad spectrum of coverage, make it a suitable agent that meets several unmet clinical needs of physicians.

Baseline findings of a multicentric ambispective cohort study (2021-2022) among hospitalised mucormycosis patients in India.

In India, the incidence of mucormycosis reached high levels during 2021-2022, coinciding with the COVID-19 pandemic. In response to this, we established a multicentric ambispective cohort of patients hospitalised with mucormycosis across India. In this paper, we report their baseline profile, clinical characteristics and outcomes at discharge. Patients hospitalized for mucormycosis during March-July 2021 were included. Mucormycosis was diagnosed based on mycological confirmation on direct microscopy (KOH/Calcofluor white stain), culture, histopathology, or supportive evidence from endoscopy or imaging. After consent, trained data collectors used medical records and telephonic interviews to capture data in a pre-tested structured questionnaire. At baseline, we recruited 686 patients from 26 study hospitals, of whom 72.3% were males, 78% had a prior history of diabetes, 53.2% had a history of corticosteroid treatment, and 80% were associated with COVID-19. Pain, numbness or swelling of the face were the commonest symptoms (73.3%). Liposomal Amphotericin B was the commonest drug formulation used (67.1%), and endoscopic sinus surgery was the most common surgical procedure (73.6%). At discharge, the disease was stable in 43.3%, in regression for 29.9% but 9.6% died during hospitalization. Among survivors, commonly reported disabilities included facial disfigurement (18.4%) and difficulties in chewing/swallowing (17.8%). Though the risk of mortality was only 1 in 10, the disability due to the disease was very high. This cohort study could enhance our understanding of the disease's clinical progression and help frame standard treatment guidelines.

Evaluating the spike in the symptomatic proportion of SARS-CoV-2 in China in 2022 with variolation effects: a modeling analysis.

Despite most COVID-19 infections being asymptomatic, mainland China had a high increase in symptomatic cases at the end of 2022. In this study, we examine China's sudden COVID-19 symptomatic surge using a conceptual SIR-based model. Our model considers the epidemiological characteristics of SARS-CoV-2, particularly variolation, from non-pharmaceutical intervention (facial masking and social distance), demography, and disease mortality in mainland China. The increase in symptomatic proportions in China may be attributable to (1) higher sensitivity and vulnerability during winter and (2) enhanced viral inhalation due to spikes in SARS-CoV-2 infections (high transmissibility). These two reasons could explain China's high symptomatic proportion of COVID-19 in December 2022. Our study, therefore, can serve as a decision-support tool to enhance SARS-CoV-2 prevention and control efforts. Thus, we highlight that facemask-induced variolation could potentially reduces transmissibility rather than severity in infected individuals. However, further investigation is required to understand the variolation effect on disease severity.

Causes and Effects of COVID-19 Vaccine Hesitancy Among Pregnant Women and its Association with Adverse Maternal, Placental, and Perinatal Outcomes.

Populations identified to be severely affected by COVID-19, such as pregnant patients, require special consideration in vaccine counseling, access, and provider education. Maternal infection with COVID-19 poses a significant risk to the maternal-fetal dyad with known adverse placenta destruction [1-5]. Despite the widespread access and availability of vaccinations, vaccine hesitancy continues to persist and is highly prevalent in pregnant populations [6-9]. Addressing the multitude of social ecological factors surrounding vaccine hesitancy can aid in providing holistic counseling [10]. However, such factors are foremost shaped by maternal concern over possible fetal effects from vaccination. While changes in policy can help foster vaccine access and acceptance, increasing global provider education and incorporation of motivational interviewing skills are the first steps towards increasing maternal acceptance.

Gastrointestinal Bleeding in COVID-19 Infected Patients, and Management Outcomes.

Introduction: Gastrointestinal bleeding in COVID-19-infection poses unique challenges to patients owing to the high risk of concomitant respiratory failure. However, endoscopic care providers are prone to transmission. This study aimed to understand the risk and management outcomes of gastrointestinal bleeding in COVID-19-infected patients. Methods: Data were abstracted from electronic patient medical records, using ICD 10 codes, and demographic and clinical data were collected, for COVID-19-infected patients who developed gastrointestinal (GI) bleeding. Complications related to COVID-19 infection and management outcomes of GI bleeding were studied. Statistically, descriptive analysis was used because of the small sample size. Results: Eighteen COVID-19-infected patients developed episodes of GI bleeding, yielding a prevalence of 0.45%. Their mean age was 74.8 years, 55.5% were female, and 66.6% of patients (n=12) had upper GI bleeding symptoms, predominantly melena (55.5%), followed by coffee ground nasogastric aspirates (n=2). Only two patients (11.11%) had episodes of lower GI bleeding, and the remaining four patients (22.2%) had recurrent acute anemia requiring blood transfusion. The Glasgow-Blatchford score (GBS) at presentation ranged between 6 to 16 (mean 8.8) and seven patients (38.8%) underwent endoscopic evaluation for GI bleeding. The predominant comorbid conditions included hypertension (22.2%), diabetes mellitus (27.7%), chronic kidney disease (50%), ischemic heart disease (33%), atrial fibrillation (11.1%), and peripheral vascular disease (11.1%). The median hospitalization was 24.6 days (range: 3-54 days). The 30-day mortality rate in our cohort was 22.2%, (4/18) mainly noted in older patients aged> 60 years with comorbid conditions and severe COVID-19 infection. Conclusion: The prevalence of GI bleeding observed in our cohort was approximately 0.45%, significantly lower than the global prevalence observed, majority (66%) had upper GI bleeding. The exact reasons for the observed low prevalence of GI bleeding cannot be explained and will be the subject of future research.

Stomach bleeding in COVID-19-infected patients is a significant threat to the patients. This study aimed to understand the risk and management of stomach bleeding in patients infected with COVID-19. Medical records were retrospectively screened using appropriate disease codes to identify patients and collect information about their demographics and complications. Only 18 patients with stomach bleeding presented to the public hospitals in Al Ain from a total of 4000 COVID-19 patients during the peak of the pandemic. Majority of the patients had upper stomach bleeding (66%); the mean age of the patients was 78 years, majority of them being female (55.5%). The major comorbidity among the patients was chronic kidney disease (50%). The average duration of hospital stay was less than 25 days and the 30-day mortality was 22%. A higher mortality rate was observed in elderly patients with severe infections. The stomach bleeding observed in our patients was far less (0.45%) that in other COVID-19 patients globally, the reasons for which are not unknown.

The continued financial effect of COVID: Increasing costs for non-elective major lower extremity amputations.

Background: The COVID-19 pandemic necessitated changes in processes of care, which significantly impacted surgical care. This study evaluated the impact of these changes on patient outcomes and costs for non-elective major lower extremity amputations (LEA). Methods: The 2019-2021 Florida Agency for Health Care Administration database was queried for adult patients who underwent non-elective major LEA. Per-patient inflation-adjusted costs were collected. Patient cohorts were established based on Florida COVID-19 mortality rates: COVID-heavy (CH) included nine months with the highest mortality, COVID-light (CL) included nine months with the lowest mortality, and pre-COVID (PC) included nine months before COVID (2019). Outcomes included in-hospital patient outcomes and hospitalization cost. Results: 6132 patients were included (1957 PC, 2104 CH, and 2071 CL). Compared to PC, there was increased patient acuity at presentation, but morbidity (31%), mortality (4%), and length of stay (median 12 [8-17] days) were unchanged during CH and CL. Additionally, costs significantly increased during the pandemic; median total cost rose 9%, room costs increased by 16%, ICU costs rose by 15%, and operating room costs rose by 15%. When COVID-positive patients were excluded, cost of care was still significantly higher during CH and CL. Conclusions: Despite maintaining pre-pandemic standards, as evidenced by unchanged outcomes, the pandemic led to increased costs for patients undergoing non-elective major LEA. This was likely due to increased patient acuity, resource strain, and supply chain shortages during the pandemic. Key message: While patient outcomes for non-elective major lower extremity amputations remained consistent during the COVID-19 pandemic, healthcare costs significantly increased, likely due to increased patient acuity and heightened pressures on resources and supply chains. These findings underscore the need for informed policy changes to mitigate the financial impact on patients and healthcare systems for future public health emergencies.

Lifestyle Medicine: An Antidote to Cardiovascular Diseases.

Despite numerous advances in basic understanding of cardiovascular disease pathophysiology, pharmacology, therapeutic procedures, and systems improvement, there hasn't been much decline in heart disease related mortality in the US since 2010. Hypertension and diet induced risk continue to be the leading causes of cardiovascular morbidity. Even with the excessive mortality associated with the COVID-19 pandemic, in 2020, heart disease remained the leading cause of death. Given the degree of disease burden, morbidity, and mortality, there is an urgent need to redirect medical professionals' focus towards prevention through simple and cost effective lifestyle strategies. However, current practice paradigm and financial compensation systems are mainly centered disease management and not health promotion. For example, the financial value placed on 3-10 min smoking cessation counseling (.24RVUs) is 47-fold lower than an elective PCI (11.21 RVUs). The medical community seems to be enamored with the latest and greatest technology, new devices, and surgical procedures. What if the greatest technology of all was simply the way we live every day? Perhaps when this notion is known by enough, we will switch to this lifestyle medicine technology to prevent disease in the first place.

COVID-19 impacts and inequities among underserved communities with diabetes.

Background: People with diabetes have higher COVID-19 morbidity and mortality. These risks are amplified for underserved communities including racial/ethnic minorities and people with lower socioeconomic status. However, limited research has examined COVID-19 outcomes specifically affecting underserved communities with diabetes. Methods: From November 2021 to July 2022, adults with insulin-requiring diabetes at federally qualified health centers in Florida and California (n = 450) completed surveys examining COVID-19 outcomes and demographics. Surveys assessed COVID-19 severity, vaccination uptake, mask-wearing habits, income changes, and healthcare access changes. Surveys also included the full Coronavirus Anxiety Scale (CAS-19). Descriptive statistics were computed for all outcomes. Between-group comparisons for state and race/ethnicity were evaluated via Chi-Squared, Fisher's Exact, Cochran-Mantel-Haenszel, One-Way ANOVA, and t-tests. Logistic regression determined factors associated with COVID-19 vaccination uptake. Data were self-reported and analyzed cross-sectionally. Results: Overall, 29.7 % reported contracting COVID-19; of those, 45.3 % sought care or were hospitalized. Most (81.3 %) received ≥ 1 vaccine. Hispanics had the highest vaccination rate (91.1 %); Non-Hispanic Blacks (NHBs) had the lowest (73.9 %; p =.0281). Hispanics had 4.63x greater vaccination odds than Non-Hispanic Whites ([NHWs]; 95 % CI = [1.81, 11.89]). NHWs least often wore masks (18.8 %; p <.001). Participants reported pandemic-related healthcare changes (62 %) and higher costs of diabetes medications (41 %). Income loss was more frequent in Florida (76 %; p <.001). NHBs most frequently reported "severe" income loss (26.4 %; p =.0124). Loss of health insurance was more common among NHBs (13.3 %; p =.0416) and in Florida (9.7 %; p =.039). COVID-19 anxiety was highest among NHBs and Hispanics (IQR = [0.0, 3.0]; p =.0232) and in Florida (IQR = [0.0, 2.0]; p =.0435). Conclusions: Underserved communities with diabetes had high COVID-19 vaccine uptake but experienced significant COVID-19-related physical, psychosocial, and financial impacts. NHBs and those in Florida had worse outcomes than other racial/ethnic groups and those in California. Further research, interventions, and policy changes are needed to promote health equity for this population.

COVID-19 surveillance report for Sudan, 2020 to 2021.

Background: Following the World Health Organization declaration, COVID-19 was first appearance in Sudan was in March 2020. Cases were reported to the Sudan Federal Ministry of Heath through the surveillance system from different sources. This study used surveillance data from 2020 to 2021 to describe the epidemiologic patterns of COVID-19 occurrence in Sudan and provide insight for better preparedness and response. Methods: Through a retrospective descriptive study, COVID19 cases records obtained from the national surveillance line-list in Surveillance and Information Directorate in Federal Ministry of Health. The analysis of data was done with SPSS version 21. Descriptive analysis done by frequencies and percentages, and further analysis through performing multivariate logistic regression. Results: Out of 48,545 suspected cases tested for COVID-19 using RT-PCR, 27,453 (56.5%) tested positive with case fatality ratio of 6.5%. Higher death rate among elderly (78% > 60-year-old) and males (70.1%). From the reported cases, 53.8% showed no symptoms, while the common symptoms among symptomatic patients were; fever (26.4%), cough (19.1%), shortness of breath (16.8%) with small proportion (4.5%) reported loss of smell and taste. Specific states, Khartoum, Gezira and Red Sea showed highest prevalence. The disease peaked four times during 2020-2021, with a proposed alert threshold of 200-250 cases per week acting as an explosion point nationwide. Conclusions: The high case fatality rate in the country requires further analysis, as well as the high proportion of asymptomatic infection. This will be ensured by improving the quality and completeness of surveillance data. A proposed threshold of 200-250 cases per week should be an alert to augment the measures of controlling the pandemic over the country, including providing enough supplies to decrease mortality.

COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial.

Background: Omalizumab is an anti-immunoglobulin E monoclonal antibody used to treat moderate to severe chronic idiopathic urticaria, asthma, and nasal polyps. Recent research suggested that omalizumab may enhance the innate antiviral response and have anti-inflammatory properties. Objective: We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for coronavirus disease 2019 (COVID-19) pneumonia. Methods: This was a phase II randomized, double blind, placebo-controlled trial comparing omalizumab with placebo (in addition to standard of care) in hospitalized patients with COVID-19. The primary endpoint was the composite of mechanical ventilation and/or death at day 14. Secondary endpoints included all-cause mortality at day 28, time to clinical improvement, and duration of hospitalization. Results: Of 41 patients recruited, 40 were randomized (20 received the study drug and 20 placebo). The median age of the patients was 74 years and 55.0% were male. Omalizumab was associated with a 92.6% posterior probability of a reduction in mechanical ventilation and death on day 14 with an adjusted odds ratio of 0.11 (95% credible interval 0.002-2.05). Omalizumab was also associated with a 75.9% posterior probability of reduced all-cause mortality on day 28 with an adjusted odds ratio of 0.49 (95% credible interval, 0.06-3.90). No statistically significant differences were found for the time to clinical improvement and duration of hospitalization. Numerically fewer adverse events were reported in the omalizumab group and there were no drug-related serious adverse events. Conclusions: These results suggest that omalizumab could prove protective against death and mechanical ventilation in hospitalized patients with COVID-19. This study could also support the development of a phase III trial program investigating the antiviral and anti-inflammatory effect of omalizumab for severe respiratory viral illnesses requiring hospital admission. ClinicalTrials.gov ID: NCT04720612.

Solutions From Mexican-Descent Perinatal Women To Pandemic-Related Food, Mental Health, And Health And Safety Stressors.

Latina women in the US were disproportionately affected by the COVID-19 pandemic because of structural racism, including discrimination, reduced care access, and elevated risk for illness and death. Although several US policies were implemented to offset the economic toll of the pandemic, few addressed complex stressors, particularly those among Mexican-descent mothers. This qualitative study with thirty-eight perinatal women and mothers of young children who were of Mexican descent sought to identify pandemic-related stressors and solicit recommendations for addressing them during future large-scale crises. Identified stressors included food access issues, mental health needs, and health and safety concerns. The women's recommendations revealed feasible and actionable strategies, including increased access to behavioral and health care services and accessible information about food-related resources. The findings highlight the critical need for responsive policies and programs to ensure the well-being of Mexican-descent perinatal women and mothers of young children during large-scale crises.

The Association between Anemia and Mortality of Severe Pneumonia COVID-19 Patients in the High Care Unit of a Tertiary Hospital in Jakarta.

BACKGROUND: Numerous studies explored the association between anemia and mortality in patients with severe pneumonia due to COVID-19. However, the findings were inconsistent. Therefore, this study was conducted to investigate the association between anemia at HCU admission and in-hospital mortality in severe pneumonia COVID-19 patients. METHODS: This retrospective cohort study obtained data on 110 COVID-19 patients with severe pneumonia who were admitted to the HCU between January, 1st 2021, and May 31st, 2021. Patients were categorized as anemic and non-anemic based on the World Health Organization (WHO) guidelines. The demographic and clinical characteristics of the subjects were described. The Chi-squared test was carried out followed by a logistic regression test to determine the association of anemia and mortality. RESULTS: Anemia was observed in 31% of 110 patients with severe pneumonia COVID-19. The source population consisted of 60.9% men and 39.1% women with a median age of 58 years. The most prevalent comorbidity was hypertension (38.2%), followed by diabetes mellitus (27.2%), renal diseases (19.1%) and heart diseases (10%). TAnemia on HCU admission was associated with in-hospital mortality in patients with severe pneumonia COVID-19 (RR: 2.794, 95% CI 1.470-5.312). After adjusting comorbidities as confounding factors, anemia was independently associated with mortality (RR: 2.204, 95% CI: 1.124-4.323, P < 0.021). The result also showed anemic patients had longer lengths of stay and higher levels of D-dimer than non-anemic patients. The median duration length of stay among the anemic and non-anemic was 16 (11-22) and 13 (9-17) days, respectively. The median D-dimer among the anemic and non-anemic was 2220 µg/ml and 1010 µg/ml, respectively. CONCLUSION: There is a significant association between anemia at HCU admission and mortality in patients with severe pneumonia COVID-19 during hospitalization.

Impacts of the COVID-19 Pandemic on the CODE ST-Segment Elevation Myocardial Infarction Program: A Quantitative and Qualitative Analysis.

BACKGROUND: The code ST-segment elevation myocardial infarction (STEMI) program is an operational standard of integrated service for STEMI patients carried out by Dr. Cipto Mangunkusumo Hospital. The emerging coronavirus disease 2019 (COVID-19) outbreak brought about many changes in the management of healthcare services, including the code STEMI program. This study aimed to evaluate the healthcare service quality of the Code STEMI program during the COVID-19 pandemic based on the Donabedian concept.  Methods: This was a mixed-methods study using quantitative and qualitative analyses. It was conducted at the Dr. Cipto Mangunkusumo Hospital, a national referral hospital in Indonesia. We compared the data of each patient, including response time, clinical outcomes, length of stay, and cost, from two years between 2018-2020 and 2020-2022 as the pre-COVID-19 code STEMI and COVID-19 Code STEMI periods, respectively. Interviews were conducted to determine the quality of services from the perspectives of stakeholders. RESULTS: A total of 195 patients participated in the study: 120 patients in pre-COVID-19 code STEMI and 75 patients in COVID-19 code STEMI. Our results showed that there was a significant increase in patient's length of stay during the COVID-19 pandemic (4 days vs. 6 days, p < 0.001). Meanwhile, MACE (13% vs. 11%, p = 0.581), the in-hospital mortality rate (8% vs. 5%, p = 0.706), door-to-wire crossing time (161 min vs. 173 min, p = 0.065), door-to-needle time (151 min vs. 143 min p = 0.953), and hospitalization cost (3,490 USD vs. 3,700 USD, p = 0.945) showed no significant changes. In terms of patient satisfaction, patients found code STEMI during COVID-19 to be responsive and excellent. CONCLUSION: The implementation of the code STEMI program during the COVID-19 pandemic revealed that modified pathways were required because of the COVID-19 screening process. According to the Donabedian model, during the pandemic, the code STEMI program's healthcare service quality decreased because of a reduction in efficacy, effectiveness, efficiency, and optimality. Despite these limitations attributed to the pandemic, the code STEMI program was able to provide good services for STEMI patients.

Analyzing the Outcomes of COVID-19 Infection on Patients With Comorbidities: Insights From Hospital-Based Study.

Introduction COVID-19 exhibits a broad spectrum of clinical manifestations, ranging from asymptomatic or mild cases to severe respiratory distress and, in some instances, fatal outcomes. The pre-existing inflammatory state in the patient prior to exposure to COVID-19, which could be because of any etiology or comorbidity, has been associated with prolonged morbidity, and adverse outcomes like increased mortality have been found. This study endeavors to investigate the principal risk factors linked to the morbidity and mortality of COVID-19, such as age, gender, and co-morbidities such as hypertension, diabetes mellitus, and others. Material and methods Patient demographic data like age, gender, and co-morbidities like diabetes mellitus, hypertension, respiratory illness, and coronary artery diseases, cerebrovascular accident was observed. The patient clinical profile, hematological, inflammatory markers at the time of admission, and outcome were noticed. Patients were divided into two groups - patients with comorbidity and those without comorbidity. Results In each cohort of COVID-19 patients, comprising those with and without comorbidities, there were 145 participants. The mean age of patients without comorbidities was found to be 49.97 years, whereas the mean age of those with comorbidities was 64.35 years. Within the comorbidity group, males formed the majority, accounting for 77.2% of the cohort; in the group without comorbidity also males predominated, representing 68.3% of the participants. Hypertension was the most common co-morbidity (89.7%), followed by diabetes mellitus (39.3%), and ischemic heart disease (8.3%). The multivariate logistic regression analysis for prediction of mortality showed hypothyroidism with odds ratio (OR) of 336.26 and confidence intervals (CI) (1.19-9477.13), ischemic heart disease with OR of 320.94 (CI 3.19-3237.4) and presence greater than two co-morbidities with OR of 42.14 (CI 1.34-1325.76). Cox regression analysis showed a statistically significant hazard ratio of 0.294 in patients with greater than two co-morbidities. Conclusion Hypothyroidism, ischemic heart disease, and the presence of multiple comorbid conditions were associated with the severity of COVID-19 illness and mortality.

Legislative incapacity and underreporting of COVID-19 mortality.

The prevalent interpretation of COVID-19 mortality underreporting typically focuses on authoritarian regimes' propensity for data manipulation. This study, however, posits that the demand side is integral to enhancing the veracity of COVID-19 mortality figures. Through quantitative analysis, it is demonstrated that legislative oversight of the executive significantly correlates with the divergence between excess mortality and officially reported COVID-19 mortality. Moreover, such oversight is shown to bolster the influence of bureaucratic capacity on the precision of mortality data. Consequently, these findings suggest that the notion of "autocratic advantage" in COVID-19 management is not solely a byproduct of regime-led data falsification but also a reflection of deficiencies in legislative and bureaucratic capacities.

The impact of comorbidities and economic inequality on COVID-19 mortality in Mexico: a machine learning approach.

Introduction: Studies from different parts of the world have shown that some comorbidities are associated with fatal cases of COVID-19. However, the prevalence rates of comorbidities are different around the world, therefore, their contribution to COVID-19 mortality is different. Socioeconomic factors may influence the prevalence of comorbidities; therefore, they may also influence COVID-19 mortality. Methods: This study conducted feature analysis using two supervised machine learning classification algorithms, Random Forest and XGBoost, to examine the comorbidities and level of economic inequalities associated with fatal cases of COVID-19 in Mexico. The dataset used was collected by the National Epidemiology Center from February 2020 to November 2022, and includes more than 20 million observations and 40 variables describing the characteristics of the individuals who underwent COVID-19 testing or treatment. In addition, socioeconomic inequalities were measured using the normalized marginalization index calculated by the National Population Council and the deprivation index calculated by NASA. Results: The analysis shows that diabetes and hypertension were the main comorbidities defining the mortality of COVID-19, furthermore, socioeconomic inequalities were also important characteristics defining the mortality. Similar features were found with Random Forest and XGBoost. Discussion: It is imperative to implement programs aimed at reducing inequalities as well as preventable comorbidities to make the population more resilient to future pandemics. The results apply to regions or countries with similar levels of inequality or comorbidity prevalence.