Clinical study evaluating the efficacy of ivermectin in COVID-19 treatment: A randomized controlled study.

Researchers around the world are working at record speed to find the best ways to treat and prevent coronavirus disease 2019 (COVID-19). This study aimed to evaluate the efficacy of ivermectin for the treatment of hospitalized mild to moderate COVID-19 infected patients. This was a randomized open-label controlled study that included 164 patients with COVID-19. Patients were randomized into two groups where Group 1 (Ivermectin group) included patients who received ivermectin 12 mg once daily for 3 days with standard care and Group 2 (control group) included patients who received standard protocol of treatment alone for 14 days. The main outcomes were mortality, the length of hospital stay, and the need for mechanical ventilation. All patients were followed up for 1 month. Overall, 82 individuals were randomized to receive ivermectin plus standard of care and 82 to receive standard of care alone. Patients in the ivermectin group had a shorter length of hospital stay (8.82 ± 4.94 days) than the control group (10.97 ± 5.28 days), but this was not statistically significant (p = 0.085). Three patients (3.7%) in each group required mechanical ventilation (p = 1.00). The death rate was three patients in the ivermectin group (3.7%) versus four patients (4.9%) in the control group without any significant difference between the two groups (p = 1.00). Although there was no statistically significant difference in any endpoints by ivermectin doses (12 mg/day for 3 days); there was an observed trend to reducing hospital stay in the ivermectin-treated group.

Expanding the liver donor pool worldwide with hepatitis C infected livers, is it the time?

Liver transplantation (LT) provides a life-saving option for cirrhotic patients with complications and hepatocellular carcinoma. Despite the increasing number of liver transplants performed each year, the number of LT candidates on the waitlist remains unchanged due to an imbalance between donor organ supply and the demand which increases the waitlist time and mortality. Living donor liver transplant had a great role in increasing the donor pool and shortened waitlist time for LT candidates. Nevertheless, further strategies can be implemented to increase the pool of potential donors in deceased donor LT, such as reducing the rate of organ discards. Utilizing hepatitis C virus (HCV) seropositive liver grafts is one of the expanded donor organ criteria. A yearly increase of hundreds of transplants is anticipated as a result of maximizing the utilization of HCV-positive organs for HCV-negative recipients. Direct-acting antiviral therapy's efficacy has revolutionized the treatment of HCV infection and the use of HCV-seropositive donors in transplantation. The American Society of Transplantation advises against performing transplants from HCV-infected liver donors (D+) into HCV-negative recipient (R-) unless under Institutional Review Board-approved study rules and with full informed consent of the knowledge gaps associated with such transplants. Proper selection of patients to be transplanted with HCV-infected grafts and confirming their access to direct-acting antivirals if needed is important. National and international consensuses are needed to regulate this process to ensure the maximum benefit and the least adverse events.

Triggers for Acceptance of COVID-19 Vaccination: A Community- Based Study.

BACKGROUND: COVID- 19 vaccines have been released, giving a major hope of getting rid of the dark pandemic crisis. The availability of vaccines does not necessarily mean that the mass vaccination program is a success. We aimed to investigate COVID-19 vaccination knowledge level, acceptance rate, and perception state among Egyptians. METHODS: An analytical cross-sectional online survey was carried out utilizing a selfadministered adult questionnaire that assesses vaccination acceptance with related sociodemographic factors and perceptions based on health belief model perspectives. Predictors of vaccination acceptance were based on logistic regression analysis. RESULTS: We analyzed data for 957 participants, aged 18-78 years, 55.7% were females, and 66.9% were healthcare workers (HCWs). About one-fourth had a history of confirmed COVID-19 infection and 56.5% would accept to have one of the COVID-19 vaccines, where "Pfizer" was the preferable one (37.8%), while "AstraZeneca" was the most rejected vaccine (26.8%). The 1st vaccine dose was received by 273 (28.5%) of which 260 were intended to receive the 2nd dose. Vaccine efficacy, side effects, protection time, and administration route were essentially among the factors that may influence their decision to accept COVID-19 vaccines. About 83.1% had good knowledge about vaccination which was significantly higher with increased age, among graduates/professionals, governmental workers, HCWs in addition to those able to save/invest money, had a history of confirmed COVID-19 infection and intending to have COVID-19 vaccine. Perceptions that vaccination decreases the chance of getting COVID-19 or its complications (OR = 9.28; CI: 5.03-17.12), vaccination makes less worry about catching COVID-19 (OR = 6.76; CI: 3.88-11.76), and being afraid of getting COVID-19 (OR = 2.04; CI: 1.26-3.31) were strong significant predictors for vaccine acceptance. CONCLUSION: Vaccine campaigns should emphasize vaccine benefits and highlight the severity of infection while addressing barriers to vaccination in order to improve vaccine coverage among populations.

The NAFLD-MAFLD debate through the lens of the Arab world.

The most common liver disease in the world is fatty liver disease related to metabolic dysfunction, yet neither patients nor medical professionals are fully aware of this. The disease, formerly known for decades as non-alcoholic fatty liver disease (NAFLD), has been renamed metabolic (dysfunction)-associated fatty liver disease (MAFLD), with many international consensus groups making recommendations on how the condition should be diagnosed and treated. This point of view explores the nomenclature change from the standpoint of Arab medical professionals and patients. The call for a name change brought up serious issues with the current nomenclature, which refers to the condition as NAFLD, and its diagnostic criteria, including the necessity for excluding alcohol consumption. The Arab world has its unique situation as regards both old and new nomenclatures. This is because of the low alcohol consumption rates in most Arab Muslim countries besides the reported high prevalence rates of obesity and its related comorbidities in the region. In our opinion, such unclarities acted as a significant roadblock to several crucial aspects of disease management in the Arab countries, including patient-doctor communication, patient awareness, partnership working, patient motivation to make lifestyle changes, and promotion of multiple health behavior changes. Many Arab world hepatologists thus wholeheartedly endorse this call to redefine the disease as they believe it will eventually positively impact the understanding and awareness of fatty liver disease, enhance patient treatment and quality of life, and reduce the load on the healthcare system.

Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.

BACKGROUND AND STUDY AIMS: Currently, there is no therapy approved for COVID-19. We evaluated the efficacy and safety of sofosbuvir/ledipasvir and nitazoxanide for the treatment of patients with COVID-19 infection. PATIENTS AND METHODS: A multicenter, open-label randomized controlled trial included one hundred and ninety patients with non-severe COVID-19 infection. Patients were randomized into three groups. All groups received standard care treatment (SCT). In addition, group 1 received sofosbuvir/ledipasvir, and group 2 received nitazoxanide. Follow-up by reverse-transcriptase polymerase chain reaction (RT-PCR) was done at intervals of 5, 8, 11, and 14 days. The primary endpoint was viral clearance. RESULTS: Viral clearance was significantly higher in the sofosbuvir/ledipasvir and nitazoxanide groups compared to the SCT group in all follow-up intervals (p < 0.001). In the sofosbuvir/ledipasvir arm, 36.9% showed early viral clearance by day 5. By day 14, 83.1% of the sofosbuvir/ledipasvir group, 39.7% of the nitazoxanide group, and 19.4% of the SCT group tested negative for SARS-CoV-2. Sofosbuvir/ledipasvir and nitazoxanide treatment were the only significant factors in Cox regression of negative RT-PCR with the highest OR (17.88, 95% CI: 6.66-47.98 and 2.59, 95% CI: 1.11-6.07, respectively). No mortality or serious adverse events were recorded. CONCLUSION: The addition of sofosbuvir/ledipasvir or nitazoxanide to the SCT results in an early and high viral clearance rate in mild and moderate patients with COVID-19. These drugs represent a safe and affordable treatment for COVID-19.

Clinico-Epidemiological Characteristics of Patients With Inflammatory Bowel Disease in Egypt: A Nationwide Multicenter Study.

Background and Aims: Ulcerative colitis (UC) and Crohn's disease (CD) are the most common types of Inflammatory bowel disease (IBD), with variable responses to traditional therapies and unpredicted prognosis. In Egypt and most developing countries, the lack of recent epidemiological and prognostic data adversely affects management strategies. We collected and analyzed data of patients with IBD from multiple centers across Egypt to evaluate patients' clinical and epidemiological characteristics. Methods: This retrospective multicenter study included patients diagnosed with IBD between May 2018 and August 2021, at 14 tertiary gastroenterology units across Egypt. Record analysis addressed a combination of clinico-epidemiological characteristics, biochemical tests, stool markers, endoscopic features, histological information, and different lines for IBD treatment. Results: We identified 1104 patients with an established diagnosis of IBD; 81% of them had UC, and 19% showed CD. The mean age of onset was 35.1 ± 12.5 years ranging from 5 to 88 years, the mean duration of illness at inclusion was 13.6 ± 16.7 years, gender distribution was almost equal with a significant male dominance (60.4%, p = 0.003) among patients with CD, 57% were living in rural areas, and 70.5% were from Delta and Coastal areas. Two hundred nineteen patients (19.8%) displayed comorbid conditions, primarily associated with CD. The most frequent complaints were diarrhea (73.2%), rectal bleeding (54.6%) that was significantly higher among patients with UC (64%, p < 0.001), and 46.8% with abdominal pain (more often with CD: 71%, p < 0.001). Conventional therapy was effective in treating 94.7% of patients. The main lesion in patients with CD was ileal (47.8%); patients with UC mainly exhibited proctosigmoiditis (28.4%). Dysplasia was detected in 7.2% of patients, mainly subjects with UC. Conclusions: To our knowledge, our effort is the first and largest cohort of Egyptian patients with IBD to describe clinical and epidemiological characteristics, and diagnostic and management approaches. More extensive prospective studies are still needed to fully characterize disease distribution, environmental factors, and pathological features of the disease.

Acute-on-chronic liver failure in Egypt: an underestimated complication of liver cirrhosis.

BACKGROUND: Acute-on-chronic liver failure (ACLF) is a severe liver cirrhosis complication with high mortality rates. Despite that chronic liver diseases are prevalent in Egypt, there is no available data about patients with ACLF. We aimed to evaluate the pattern of ACLF in Egypt. METHODS: This prospective cohort study included all patients with ACLF, according to the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver, admitted to Al-Rajhi liver Hospital, Egypt, between November 2018 and October 2019. We recorded data at admission, days 3, 7, 14 and 28, and calculated ACLF grades and Chronic Liver Failure Consortium scores until discharge or death. Kaplan-Meier survival analysis was used for survival analysis. RESULTS: We analyzed 52 patients with ACLF. Liver cirrhosis was secondary to hepatitis C virus in 46 patients (88.9%), and hepatitis B virus in 4 (7.4%). The main ACLF precipitating factors were infection in 38 (73.1%) and variceal bleeding in 9 (17.3%). The most common infections were spontaneous bacterial peritonitis (44.7%) and chest infection (31.6%). The 28 and 90-day mortality rates were 86.5 and 96.2%. None of the patients who survived >28 days had ACLF 3 at admission or day 7. Among those who died <28 days, ACLF 3 was reported in 7 at admission and 19 on day 7. Living donor liver transplantation was not offered in any case. CONCLUSION: In this study, the 28-day mortality rate was higher than in the literature. Egypt urgently needs to develop specific protocols for the proper management of ACLF.

Ocular Manifestations of Post-Acute COVID-19 Syndrome, Upper Egypt Early Report.

PURPOSE: To evaluate the ocular manifestations of post-acute COVID-19 syndrome. METHODS: A retrospective, comparative study included 100 patients who had recovered from COVID-19 and 100 controls who were recruited by stratified randomization from hospital registration system and analyzed regarding history, full ophthalmological examination, general examination including internal medicine and neurological evaluation. Laboratory tests were done. RESULTS: Mean±SD of age were 55.5 ± 6.2 in COVID group vs 56.5 ± 5.8 in control group; P value = 0.7. In COVID group, 57 patients (57%) were males vs 51 patients (51%) in control group (P value = 0.39), the other compared parameters including history and risk factors showed non-significant difference except for ESR and D-dimer which were elevated in COVID group. In COVID group, 5 patients (5%) were having retinal vascular occlusion, 2 patients (2%) were having anterior ischemic optic neuropathy AION, 3 patients (3%) were having uveitis and 2 patients (2%) were having central serous chorioretinopathy CSCR. While in control group, 2 patients (2%) were having retinal vascular occlusion, and none had AION, uveitis or CSCR (P value = 0.006). CONCLUSION: Post-acute COVID-19 syndrome could affect the eyes in the form of coagulation problems, neurological morbidities, and other manifestations. This necessitates meticulous follow-up of recovered patients from COVID-19.

Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial.

No specific treatment for COVID-19 infection is available up till now, and there is a great urge for effective treatment to reduce morbidity and mortality during this pandemic. We aimed to evaluate the effect of combining chloroquine/hydroxychloroquine (CQ/HCQ) and zinc in the treatment of COVID-19 patients. This was a randomized clinical trial conducted at three major University hospitals in Egypt. One hundred ninety-one patients with a confirmed diagnosis of COVID-19 infection were randomized into two groups: group I (96) patients received both HCQ and zinc, and group II (95) received HCQ only. The primary endpoints were the recovery within 28 days, the need for mechanical ventilation, and death. The two groups were matched for age and gender. They had no significant difference regarding any of the baseline laboratory parameters or clinical severity grading. Clinical recovery after 28 days was achieved by 79.2% in the zinc group and 77.9% in zinc-free treatment group, without any significant difference (p = 0.969). The need for mechanical ventilation and the overall mortality rates did not show any significant difference between the 2 groups either (p = 0.537 and 0.986, respectively). The age of the patient and the need for mechanical ventilation were the only risk factors associated with the patients' mortality by the univariate regression analysis (p = 0.001 and < 0.001, respectively). Zinc supplements did not enhance the clinical efficacy of HCQ. More randomized studies are needed to evaluate the value of adding zinc to other therapies for COVID 19. ClinicalTrials.gov Identifier: NCT04447534.

Hepatic and gastrointestinal disturbances in Egyptian patients infected with coronavirus disease 2019: A multicentre cohort study.

BACKGROUND: Various liver and gastrointestinal involvements occur in patients with coronavirus disease 2019 (COVID-19) at variable prevalence. Most studies report mild liver function disturbances correlated with COVID-19 severity, though liver failure is unusual. AIM: To study liver and gastrointestinal dysfunctions in Egyptian patients with COVID-19 and their relation to disease outcomes. METHODS: This multicentre cohort study was conducted on 547 Egyptian patients from April 15, 2020 to July 29, 2020. Consecutive polymerase chain reaction-confirmed COVID-19 cases were included from four quarantine hospitals affiliated to the Egyptian ministry of health. Demographic information, laboratory characteristics, treatments, fibrosis-4 (FIB-4) index, COVID-19 severity, and outcomes were recorded and compared according to the degree of liver enzyme elevation and the presence of gastrointestinal symptoms. Follow-ups were conducted until discharge or death. Regression analyses were performed to determine the independent factors affecting mortality. RESULTS: This study included 547 patients, of whom 53 (9.68%) died during hospitalization and 1 was discharged upon his request. Patients' mean age was 45.04 ± 17.61 years, and 21.98% had severe or critical COVID-19. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were available for 430 and 428 patients, respectively. In total, 26% and 32% of patients had elevated ALT and AST, respectively. Significant liver injury with ALT or AST elevation exceeding 3-fold was recorded in 21 (4.91%) and 16 (3.73%) patients, respectively. Male gender, smoking, hypertension, chronic hepatitis C, and lung involvement were associated with elevated AST or ALT. AST was elevated in 50% of patients over 60-years-old. FIB-4 was significantly higher in patients admitted to the intensive care unit (ICU), those with more severe COVID-19, and non-survivors. The independent variables affecting outcome were supplementary vitamin C intake (1 g daily capsules) [odds ratio (OR): 0.05, 95% confidence interval (CI): 0.008-0.337]; lung consolidation (OR: 4.540, 95%CI: 1.155-17.840); ICU admission (OR: 25.032, 95%CI: 7.110-88.128); and FIB-4 score > 3.25 (OR: 10.393, 95%CI: 2.459-43.925). Among 60 (13.98%) patients with gastrointestinal symptoms, 52 (86.67%) had diarrhoea. Patients with gastrointestinal symptoms were predominantly females with higher body mass index, and 50 (83.40%) patients had non-severe COVID-19. CONCLUSION: Few Egyptian patients with COVID-19 developed a significant liver injury. The independent variables affecting mortality were supplementary vitamin C intake, lung consolidation, ICU admission, and FIB-4 score.

RETRACTED: Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.

RETRACTED ARTICLE: The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation (P = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group (P = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.

Predictors of Severity and Co-Infection Resistance Profile in COVID-19 Patients: First Report from Upper Egypt.

BACKGROUND: The emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) resulted in a worldwide devastating effect with a diagnostic challenge. Identifying risk factors of severity aids in assessment for the need of early hospitalization. We aimed to demonstrate, for the first time, the clinical, laboratory and radiological characteristics of coronavirus disease 2019 (COVID-19) patients, to identify the predictors of severity and to describe the antimicrobial resistance profile in patients from Upper Egypt. MATERIALS AND METHODS: Demographic characters, clinical presentations, laboratory, and radiological data were recorded and analyzed. Presence of other respiratory microorganisms and their sensitivity patterns were identified using the VITEK2 system. Resistance-associated genes were tested by PCR. RESULTS: The study included 260 COVID-19 patients. The majority were males (55.4%) aged between 51 and 70 years. Hypertension, diabetes, and ischemic heart disease were common comorbidities. Main clinical manifestations were fever (63.8%), cough (57.7%), dyspnea (40%) and fatigue (30%). According to severity, 51.5% were moderate, 25.4% mild and 23% severe/critical. Lymphopenia, elevated CRP, ferritin, and D-dimer occurred in all patients with significantly higher value in the severe group. Age >53 years and elevated ferritin ≥484 ng/mL were significant risk factors for severity. About 10.7% of the COVID-19 patients showed bacterial and/or fungal infections. Klebsiella pneumoniae, Acinetobacter baumannii, and Staphylococcus aureus were the predominant isolated bacteria while Candida albicans and Candida glabrata were the predominant isolated fungi. All Staphylococci were methicillin-resistant and carried the mecA gene. Gram-negative isolates were multidrug-resistant and carried different resistance-associated genes, including NDM-1, KPC, TEM, CTX-M, and SHV. CONCLUSION: Older age and elevated serum ferritin were significant risk factors for severe COVID-19. Bacterial co-infection and multidrug resistance among patients with COVID-19 in Upper Egypt is common. Testing for presence of other co-infecting agents should be considered, and prompt treatment should be carried out according to the antimicrobial sensitivity reports.