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Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed.To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19.The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.ClinicalTrials.gov Identifier: NCT04920942.

Background: The prognostic value of diastolic dysfunction estimates in clinical settings is not well established. We aimed to evaluate the impact of the 2016 American Society of Echocardiography and the European Association of Cardiovascular Imaging recommendations on estimates of diastolic dysfunction and predicting cardiovascular outcomes in patients with diabetes and hypertension. Methods: In total, 111 patients with diabetes and hypertension without a known history of cardiovascular diseases were enrolled. All patients had preserved left ventricular ejection fraction on echocardiography at screening. Echocardiography was performed at baseline. The 2009 and 2016 algorithms were applied in diastolic function assessment. All patients were followed up for 1 year to assess clinical outcomes. Results: There were 65 (58.6%) female patients. The mean age was 59.86 ± 7.45 years, and the mean duration of diabetes was 10.5 ± 5.41 years. Fifty-five (50.5%) patients had left ventricular hypertrophy on echocardiography. The prevalence of diastolic dysfunction was lower and that of indeterminate diastolic function was higher with 2016 recommendations. Concordance between 2016 and 2009 recommendations was poor with a reclassification rate of 41.4%. No patients diagnosed with indeterminate and normal diastolic function using the 2016 algorithm and diastolic dysfunction using the 2009 algorithm developed major adverse cardiac events at 1 year. Two of 11 patients diagnosed with diastolic dysfunction using both recommendations and two of five patients diagnosed with diastolic dysfunction and indeterminate diastolic function using 2016 and 2009 recommendations, respectively, developed major adverse cardiac events at 1 year. The 2016 algorithm showed better accuracy in predicting major adverse cardiac events at 1 year. Conclusion: The updated 2016 criteria detect more advanced diastolic dysfunction cases and predict 1-year cardiovascular outcomes. Further studies are warranted to investigate the prognostic impact of these criteria. Trial registration number: NMRR-16-436-29619.

BackgroundRapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. MethodsHospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia,venous thromboembolism,myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell’s Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. ResultsThere was no increase in the risk for myocarditis/pericarditis, Bell’s Palsy, stroke, and myocardial infarction in the 21days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine showed significant association for thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). ConclusionThis study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

ImportanceIvermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed. ObjectiveTo determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19. Design, Setting, and ParticipantsThe Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients’ symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease. InterventionsPatients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging. Main Outcomes and MeasuresThe primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events. ResultsAmong 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80;P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30;P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20;P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11;P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group). Conclusions and RelevanceIn this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.

Objectives This study compared the condom failure rate, safety and acceptability of two new synthetic adhesive male condoms, Wondaleaf-Cap® (WLC) and Wondaleaf-On-Man® (WLM), with a marketed latex external condom Durex®-Together (DT). Study design We enrolled healthy married, monogamous, heterosexual condom users in a randomized controlled, cross-over, pilot trial in Malaysia. We randomized participants to six groups with different condom use-orders of the experimental WLC and WLM and control latex condom for four episodes for vaginal sex over 1 month for each condom type. We summarized the clinical and non-clinical failure rate, safety and acceptability of each condom type using descriptive statistics. We tested differences in condom failure and acceptability using generalized estimating equations and repeated measure ANOVA respectively. Results We screened 75 couples and randomized 50 eligible couples. Two couples withdrew before receiving any condom. The remaining used 576 condoms with 192 uses for each condom variant. Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively. Non-clinical failure rates of WLC, WLM and DT were 2.08%, 3.12% and 1.04%, respectively. Removal was found more painful with Wondaleaf products than the DT. Preferences of participants for WLC, WLM and DT were 33.3%, 29.2% and 25%, respectively. Overall, WLC and DT had greater acceptances among male participants than WLM. Conclusion Results of this pilot study support that use of synthetic adhesive male condoms is associated with failure rates similar to those seen with existing latex, and with greater acceptability. A larger study to ascertain non-inferiority is underway. Implications The availability of synthetic adhesive male condoms may increase the acceptability of condom use. However, removal pain and clinical performance requires further study.

Sarawak General Hospital, which is the only public access tertiary referral center in Sarawak State for all clinical specialties, was designated a hybrid hospital to treat both COVID-19 and non-COVID-19 patients. During the initial surge of patients admitted with COVID-19, there was also a corresponding increase in health-care workers (HCWs) detected with COVID-19 infection. The latter being isolated, and the large number of staff members that had come into contact with COVID-19 being quarantined from work, placed further strain on the health-care services. The staff mass screening strategy was a policy decision made by the hospital in response to infection among HCWs, and it aimed to reduce in-hospital transmission (particularly among asymptomatic staff), mitigate workforce depletion due to quarantining, and protect the health-care workforce. In this study, we assessed the detection rate of COVID-19 infection from staff mass testing over a five-week period, and described our experience of adopting this surveillance screening strategy alongside ongoing contact tracing and symptomatic screening strategies. Although it was thought that such periodic staff surveillance might be helpful in protecting the health-care workforce within a short period, the long-term implications, especially in settings with limited resources, is significant and therefore explored in this paper. Our findings might provide an evidence-based reference for the future planning of an optimal strategy with the least compromise in care for a larger proportion of non-COVID-19 patients amid efforts against COVID-19 in a large nonCOVID-designated hospital with hybrid status.

IntroductionIntroduction This study aimed to evaluate risk factors associated with SARS-CoV-2 infection among HCWs who had exposure from infected patients and HCWs in a recent outbreak in Sarawak General Hospital (SGH). Materials and Methods We included HCWs who were investigated during contact tracing of SARS-CoV-2 confirmed patients and HCWs in SGH. We analysed the risk factors including personal protective equipment (PPE) use, social distancing, contact duration, hand hygiene practice, and involvement in aerosol producing activities associated with HCW’s SARSCoV-2 infection risk, which was confirmed by using real-time polymerase chain reaction assay. Results We included 2104 HCWs: 62.2% were female with median age of 32 years old. Majority were nurses (45.3%) and doctors (29.8%). Fifty (2.4%) HCWs were later confirmed with SARS-CoV-2 infection. Among them, 12 had exposure from infected patient(s); 34 from infected HCW(s); and four had contacted both infected patient(s) and HCW(s). Discussion & Conclusion Aerosol-producing activities and hand hygiene were the significant risk factors associated with SARSCoV-2 infection risk in HCWs. The findings indicate indirect contact of contaminated surfaces or formite transmission as the possible transmission mode of SARS-CoV-2. Actions are needed to reinforce hand hygiene habits and practice while use of mask and PPEs should not be undermined in the effort of preventing nosocomial transmission of SARS-CoV-2. In univariable and multivariable analyses, in patient-HCW exposure, aerosol-producing activities was the only risk factor significantly associated with SARS-CoV-2 infection [OR=4.55, 95%CI=1.14-18.12], while in HCW-HCW exposure, hand hygiene was the sole significant risk factor (OR=2.21, 95%CI=1.13-4.31). Not wearing mask in HCW-HCW contact showed marginal significance level in univariable analysis (p=0.06, OR=6.98, 95%CI=0.93-50.03). Other risk factors were not found to significantly associated with SARS-CoV-2 infection risk in HCWs

Background Located on the Borneo Island, Sarawak is the largest state of Malaysia and has a population distinctive from Peninsular Malaysia. The ischaemic stroke data in Sarawak had not been reported despite the growing number of patients annually. We aimed to investigate patient characteristics, management, and outcomes of ischaemic stroke in Sarawak and benchmark the results with national and international published data. Methods We included ischaemic stroke cases admitted to Sarawak General Hospital between June 2013 and August 2018 from Malaysia National Stroke Registry. We performed descriptive analyses on patient demographics, cardiovascular risk factors, prior medications, smoking status, arrival time, thrombolysis rate, Get With The Guidelines (GWTG)-Stroke measures, and outcomes at discharge. We also numerically compared the results from Sarawak with the published data from selected national and international cohorts. Results We analysed 1435 ischaemic stroke cases. The mean age was 60.1±13.2 years old; 64.9% were male; median baseline National Institute of Health Stroke Scale was seven points. Hypertension was the most prevalent risk factor of ischaemic stroke; 12.7% had recurrent stroke; 13.7% were active smokers. The intravenous thrombolysis rate was 18.8%. We achieved 80–90% in three GWTG-Stroke performance measures and 90–98% in four additional quality measures in our ischaemic stroke management. At discharge, 57% had modified Rankin Scale of 0–2; 6.7% died during hospitalisation. When compared with selected national and international data, patients in Sarawak were the youngest; Sarawak had more male and more first-ever stroke. Thrombolysis rate in Sarawak was higher compared with most studies in the comparison. Functional outcome at discharge in Sarawak was better than national cohort but still lagging behind when compared with the developed countries. In-hospital mortality rate in Sarawak was slightly lower than the national data but higher when compared with other countries. Conclusion Our study described characteristics, management, and outcomes of ischaemic stroke in Sarawak. We achieved high compliance with most of GTWG-Stroke performance and quality indicators. Sarawak had better outcomes than the national results on ischaemic stroke. However, there is still room for improvement when compared with other countries. Actions are needed to reduce the cardiovascular burdens for stroke prevention, enhance healthcare resources for stroke care, and improve intravenous thrombolysis treatment in Sarawak. Full Text Link:https://doi.org/10.1016/j.jstrokecerebrovasdis.2020.105012