Factors Influencing Participation in COVID-19 Clinical Trials: A Multi-National Study

In 2020, the World Health Organization has characterized COVID-19, a disease caused by infection with the SARS-CoV-2 virus, as a pandemic. Although a few vaccines and drugs have been approved to, respectively, prevent or treat the disease, several clinical trials are still ongoing to test new vaccines or drugs to mitigate the burden of the pandemic. Few studies have shown the role of host genetics in disease prognosis and drug response highlighting the importance of diverse participation in COVID-19 clinical trials. The goal of this study is to assess public attitudes in Egypt, Saudi Arabia, and Jordan toward participating in COVID-19 clinical trials and to identify the factors that may influence their attitude. An online questionnaire was developed and distributed among the target group through social media platforms. The number of responses was 1,576. Three quarters (74.9%) of participants heard about clinical trials before, 57.6% of them had a positive attitude toward participation in COVID-19 clinical trials. The conduct of clinical trials in accordance with the scientific, research, and ethical guidelines was a strong predictor of willingness to participate in clinical trials. Other positive factors also included protection of family from COVID-19 and contributing to the return to normal community life as well as receiving additional healthcare benefit was the fourth significant predictor. On the other hand, the thought that clinical trials can have a negative impact on the health of participants strongly predicted the unwillingness of individuals to participate in such trials. This was followed by having limited information about the novel coronavirus and COVID-19 and the lack of trust in physicians and hospitals. In general, Arab citizens are accepting the concept and have a positive attitude toward COVID-19 clinical trials. Increasing awareness of COVID-19 and clinical trials, enforcing the concept of altruism, and placing clear policies in conducting clinical trials are needed to increase participation in clinical trials among Arabs

Prevalence of trachoma in four marakez of Elmenia and Bani Suef Governorates, Egypt.

PURPOSE: In 2015, to determine where interventions are needed to eliminate trachoma as a public health problem from Egypt, we initiated population-based prevalence surveys using the Global Trachoma Mapping Project platform in four suspected-endemic marakez (districts; singular: markaz) of the governorates of Elmenia and Bani Suef. METHODS: In each markaz, 30 households were selected in each of 25 villages. Certified graders examined a total of 3682 children aged 1-9 years in 2993 households, noting the presence or absence of trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI) in each eye. A total of 5582 adults aged ≥15 years living in the same households were examined for trachomatous trichiasis (TT). Household-level access to water and sanitation was recorded. RESULTS: Three of four marakez had age-adjusted TF prevalence estimates in 1-9-year olds of >10%; the other markaz had a TF prevalence estimate of 5-9.9%. Estimates of the age- and gender-adjusted prevalence of unmanaged TT in adults ranged from 0.7% to 2.3%. Household-level access to water and sanitation was high. (We did not, however, measure use of water or sanitation facilities.) Conclusions: Each of the four marakez surveyed has trachoma as a public health problem, with a need for implementation of the SAFE (surgery, antibiotics, facial cleanliness, environmental improvement) strategy. Further mapping is also required to determine the need for interventions in other areas of Egypt

Sinopharm’s BBIBP-CorV Vaccine and ChAdOx1 nCoV-19 Vaccine Are Associated with a Comparable Immune Response against SARS-CoV-2

Coronavirus disease 2019 (COVID-19) has affected millions of people worldwide. During the early stages of vaccination in Egypt, the ChAdOx1 nCoV-19 and BBIBP-CorV vaccines were the most distributed. The aim of this study was to compare the immune responses and short-term efficacies of these two vaccines. We recruited adults who received two doses of either vaccine. Samples were collected after the first dose of ChAdOx1 nCoV-1 and after the second dose of both vaccines. Antibodies against SARS-CoV-2 antigens were measured using LABScreen™ COVID Plus kits, and cell-mediated immune responses were assessed using flow cytometry. Of the 109 recruited subjects, 60 (55%) received the ChAdOx1 nCoV-19 vaccine, and the remainder received the BBIBP-CorV vaccine. The total antibody level did not significantly differ between the two groups. The level of the anti-spike subunit 2 (S2) antibody was significantly higher in the ChAdOx1 nCoV-19 group. The percentages of both total T cells and B cells were unaffected by the type of vaccination. However, the ChAdOx1 nCoV-1 vaccine was significantly associated with a higher percentage of CD8+ cells. The vaccines did not significantly differ in the number or severity of infections postvaccination. None of the participants were admitted to the hospital or died of COVID-19 infection. In conclusion, the BBIBP-CorV vaccine is associated with an immune response and protection against infection that is comparable to that of the ChAdOx1 nCoV-1 vaccine. Follow-up is needed to study the long-term protective effects of both vaccines. Inactivated vaccines are easier to manufacture in developing countries and their limited side effects may lead to better economic benefits by limiting the number of absences from work

Knowledge, perceptions and attitude of Egyptian physicians towards biobanking issues.

ObjectivesCollection and storage of biospecimens and data for biobanking raise many ethical concerns. Stakeholders' opinions about these ethical issues are important since they can help in the development of ethical guidelines to govern biobanking activities. Physicians are among the important stakeholders since they contact potential participants and could be biobank users. The goal of this study is to evaluate the perceptions and attitude of Egyptian physicians towards ethical issues in biobanking.MethodsA cross-sectional online survey was designed and distributed with the target group between November 2019 and January 2020.ResultsThe questionnaire was completed by 223 physicians. While 65.5% reported hearing the term "Biobanking" before, 45.7% knew that there are biobanks in Egypt. Participants had a general positive attitude towards the value of biobanks in research. About 73% agreed that biobanks can share biospecimens with international research organizations, but only 42.6% supported collaboration with pharmaceutical companies, and 44% agreed to the use of user fees by biobanks. About 48% supported the use of broad consent in biobanks, and 73.1% believed that donors of biospecimens should be informed about results of research performed on their biospecimens.ConclusionAlthough many Egyptian physicians heard about biobanking, they had limited knowledge about the existence of biobanks in Egypt. They had concerns about commercialization, use of broad consent and user fees. A knowledge gap exists among these stakeholders, which should be covered by different educational activities. Community discussions should start to reach consensus about the issues of commercialization and return of research results

Circulating ESR1, long non-coding RNA HOTAIR and microRNA-130a gene expression as biomarkers for breast cancer stage and metastasis

Abstract Breast cancer, the most prevalent cancer among women, has posed a significant challenge in identifying biomarkers for early diagnosis and prognosis. This study aimed to elucidate the gene expression profile of Estrogen Receptor-1 (ESR-1), long non-coding RNA HOTAIR, and microRNA-130a in the serum of Egyptian breast cancer patients, evaluating the potential of HOTAIR and miR-130a as biomarkers for predicting pathological parameters in BC. The study involved 45 patients with primary BC, with serum samples collected preoperatively and postoperatively twice. The expression levels of ESR-1, HOTAIR, and miR-130a were quantified using real-time PCR and analyzed for correlations with each other and with the clinical and pathological parameters of the patients. Serum HOTAIR levels exhibited a strong positive association with metastasis and demonstrated a significant increase after 6 months in all patients with locally advanced and stage IV BC. Conversely, tumors with advanced stages and metastatic lesions showed significantly lower expression levels of miR-130a. Notably, a significant positive correlation was observed between preoperative ESR-1 expression and both HOTAIR and miR-130a levels. Serum HOTAIR and miR-130a levels have emerged as promising non-invasive biomarkers with the potential to predict the pathological features of BC patients. HOTAIR, an oncogenic long non-coding RNA (lncRNA), and miR-130a, a tumor suppressor miRNA, play crucial roles in tumor progression. Further investigations are warranted to elucidate the intricate interplay between HOTAIR and miR-130a and to fully comprehend the contribution of HOTAIR to BC recurrence and its potential utility in early relapse prediction

Elevation of D-dimer levels are associated with early need for mechanical ventilation support in patients with COVID-19

Abstract Background Severe COVID-19 disease is typically associated with an urgent need for supplemental oxygen therapy that may be successfully delivered through conventional methods or require invasive mechanical ventilation. Early prediction of the need for invasive mechanical ventilation could significantly improve outcomes of COVID-19 patients. Plasma levels of D-dimer and a number of inflammatory markers as well as values of complete blood counts, all measured in the first two days of hospital admission of COVID-19 patients, were evaluated for their significance as predictors of the eventual need for invasive mechanical ventilation support as well as their values as predictors of post-ventilation morbidly and mortality. Methods This retrospective cohort study was conducted at a single center and included data pertaining to 200 patients with previously confirmed moderate to severe COVID-19 disease in the period between May 2021 and the end of December 2022. Data were retrieved from medical records for further analysis. Results The mean (SD) age of patients stood at 59 (14) years of age, and with a majority of patients being male (77%). About 18% of cases, all of significantly older age, had been connected to invasive mechanical ventilation (IMV). Total leucocytic count (TLC), as well as levels of urea, creatinine, D-dimer, ferritin, and CRP in IMV patients were significantly higher than non-ventilated patients (p < 0.01 for all). In contrast, lymphocytic count, hemoglobin level, and platelet count were significantly lower in IMV patients (p < 0.001, 0.04, and 0.002, respectively). The mortality rate was significantly higher in IMV patients (p < 0.001). D-dimer independently predicted IMV demand (OR = 1, p = 0.001 in adjusted and unadjusted models). The utility of D-dimer was excellent; and the cutoff level of above 1415 µ/L showed sensitivity and specificity of about 92% and 76%, respectively. Also, the D-dimer level was very effective in predicting post-IMV survival; the AUC = 0.86, p = 0.02, and a cutoff value below 4558 µ/L was associated with 100% and 66% sensitivity and specificity, respectively. Conclusions High D-dimer levels independently correlated with the need for invasive mechanical ventilation. Low levels of this marker could evidently predict post-IMV survival of mechanically ventilated COVID-19 patients. Measuring D-dimer levels during routine follow up of those patients would thus be useful in predicting patient outcomes

Prevalence of trachoma in four marakez of Elmenia and Bani Suef Governorates, Egypt.

PurposeIn 2015, to determine where interventions are needed to eliminate trachoma as a public health problem from Egypt, we initiated population-based prevalence surveys using the Global Trachoma Mapping Project platform in four suspected-endemic marakez (districts; singular: markaz) of the governorates of Elmenia and Bani Suef.MethodsIn each markaz, 30 households were selected in each of 25 villages. Certified graders examined a total of 3682 children aged 1-9 years in 2993 households, noting the presence or absence of trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI) in each eye. A total of 5582 adults aged ≥15 years living in the same households were examined for trachomatous trichiasis (TT). Household-level access to water and sanitation was recorded.ResultsThree of four marakez had age-adjusted TF prevalence estimates in 1-9-year olds of &gt;10%; the other markaz had a TF prevalence estimate of 5-9.9%. Estimates of the age- and gender-adjusted prevalence of unmanaged TT in adults ranged from 0.7% to 2.3%. Household-level access to water and sanitation was high. (We did not, however, measure use of water or sanitation facilities.) Conclusions: Each of the four marakez surveyed has trachoma as a public health problem, with a need for implementation of the SAFE (surgery, antibiotics, facial cleanliness, environmental improvement) strategy. Further mapping is also required to determine the need for interventions in other areas of Egypt