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Reduction of SARS-CoV-2 viral load in saliva after rinsing with mouthwashes containing cetylpyridinium chloride: a randomized clinical study.
Bezinelli, LM, Corrêa, L, Beyerstedt, S, Franco, ML, Rangel, ÉB, Benítez, CG, Hamerschlak, N, Pinho, JRR, Heller, D, Eduardo, FP
PeerJ. 2023;:e15080
Abstract
BACKGROUND Symptomatic patients with COVID-19 typically have a high SARS-CoV-2 viral load in their saliva. Procedures to reduce the viral load in their oral cavity are important for mitigating the viral transmission. METHODS This randomized clinical trial investigated the impact of two mouthwashes (0.075% cetylpyridinium chloride plus 0.28% zinc lactate (CPC+Zn) (n = 32), and 0.075% cetylpyridinium chloride (CPC) (n = 31)) on the viral load of SARS-CoV-2 in saliva when compared to the distilled water negative control (n = 32). Saliva was collected before (T0) and after (5 min, T1; 30 min, T2; and 60 min, T3) the intervention. Viral load in saliva was measured by qRT-PCR assays. The data in both groups was normalized for T0 and Negative Control, resulting in fold change values. RESULTS CPC+Zn oral solution reduced the viral load in saliva by 6.34-fold at T1, 3.6-fold at T2 and 1.9-fold at T3. Rinsing with the CPC mouthwash reduced the viral load in saliva by 2.5-fold at T1, 1.9-fold at T2 and 2.0-fold at T3. CONCLUSION CPC+Zn mouthwash or with the CPC mouthwash reduced the viral load in saliva of COVID-19 patients immediately after rinsing. These reductions extended up to 60 min.
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Shared Decision-Making in General Surgery: Prospective Comparison of Telemedicine vs In-Person Visits.
Hawkins, AT, Ueland, T, Aher, C, Geiger, TM, Spann, MD, Horst, SN, Schafer, IV, Ye, F, Fan, R, Sharp, KW
Journal of the American College of Surgeons. 2023;(4):762-771
Abstract
BACKGROUND The coronavirus disease 2019 (COVID-19) pandemic has accelerated a shift toward virtual telemedicine appointments with surgeons. While this form of healthcare delivery has potential benefits for both patients and surgeons, the quality of these interactions remains largely unstudied. We hypothesize that telemedicine visits are associated with lower quality of shared decision-making. STUDY DESIGN We performed a mixed-methods, prospective, observational cohort trial. All patients presenting for a first-time visit at general surgery clinics between May 2021 and June 2022 were included. Patients were categorized by type of visit: in-person vs telemedicine. The primary outcome was the level of shared decision-making as captured by top box scores of the CollaboRATE measure. Secondary outcomes included quality of shared decision-making as captured by the 9-item Shared Decision-Making Questionnaire and satisfaction with consultation survey. An adjusted analysis was performed accounting for potential confounders. A qualitative analysis of open-ended questions for both patients and practitioners was performed. RESULTS During a 13-month study period, 387 patients were enrolled, of which 301 (77.8%) underwent in-person visits and 86 (22.2%) underwent telemedicine visits. The groups were similar in age, sex, employment, education, and generic quality-of-life scores. In an adjusted analysis, a visit type of telemedicine was not associated with either the CollaboRATE top box score (odds ratio 1.27; 95% CI 0.74 to 2.20) or 9-item Shared Decision-Making Questionnaire (β -0.60; p = 0.76). Similarly, there was no difference in other outcomes. Themes from qualitative patient and surgeon responses included physical presence, time investment, appropriateness for visit purpose, technical difficulties, and communication quality. CONCLUSIONS In this large, prospective study, there does not appear to be a difference in quality of shared decision making in patients undergoing in-person vs telemedicine appointments.
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Efficacy and Safety of Dapagliflozin versus Liraglutide in Patients with Overweight or Obesity and Type 2 Diabetes Mellitus: A Randomised Controlled Clinical Trial in Tianjin, China.
Zhaohu, H, Xiao, H, Hailin, S, Feng, H
Journal of diabetes research. 2022;:4126995
Abstract
OBJECTIVE We aimed to clarify the efficacy of dapagliflozin versus liraglutide in patients with overweight or obesity and type 2 diabetes mellitus (T2DM) at the beginning of the coronavirus disease 2019 (COVID-19) pandemic. METHODS T2DM patients with overweight or obesity who visited the Metabolic Disease Management Center at Tianjin Fourth Central Hospital from October 2019 to January 2020 were recruited and randomised to receive dapagliflozin or liraglutide for 24 weeks. Changes in blood glucose and lipid levels, blood pressure, and body weight, as well as the occurrence of hypoglycaemia and other adverse events, were compared. RESULTS 309 patients completed the study (143 in liraglutide group and 166 in dapagliflozin group). After 24 weeks, HbA1c, fasting blood glucose (FPG), and 2 h postprandial blood glucose (2hPG) levels significantly decreased from 8.80% ± 1.41% to 7.02% ± 1.05%, 10.41 ± 3.13 to 7.59 ± 2.16 mmol/L, and 17.90 ± 4.39 to 10.12 ± 2.47 mmol/L, respectively, in the dapagliflozin group, and from 8.92% ± 1.49% to 6.78% ± 1.00%, 10.04 ± 2.99 to 7.20 ± 1.63 mmol/L, and 17.30 ± 4.39 to 10.13 ± 4.15 mmol/L, respectively, in the liraglutide group. Changes in HbA1c, FPG, and 2hPG levels between groups were not significantly different. Systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) level significantly decreased from 144.1 ± 19.1 to 139.7 ± 16.2 mmHg (p = 0.001) and from 3.21 ± 0.94 to 2.98 ± 0.89 mmol/L (p = 0.014), respectively, in the dapagliflozin group. After COVID-19 outbreak, the number of patients taking sleep-promoting drugs increased from 4.9% to 9.4% (p = 0.029). CONCLUSIONS Liraglutide and dapagliflozin had strong hypoglycaemic effects in patients with overweight or obesity and T2DM at the beginning of the COVID-19 pandemic. Dapagliflozin may be beneficial in improving SBP and LDL-C levels; however, further research is warranted.
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Chinese Medicine Meets Conventional Medicine in Targeting COVID-19 Pathophysiology, Complications and Comorbidities.
Wang, SS, Zeng, X, Wang, YL, Dongzhi, Z, Zhao, YF, Chen, YZ
Chinese journal of integrative medicine. 2022;(7):627-635
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OBJECTIVE To investigate how the National Health Commission of China (NHCC)-recommended Chinese medicines (CMs) modulate the major maladjustments of coronavirus disease 2019 (COVID-19), particularly the clinically observed complications and comorbidities. METHODS By focusing on the potent targets in common with the conventional medicines, we investigated the mechanisms of 11 NHCC-recommended CMs in the modulation of the major COVID-19 pathophysiology (hyperinflammations, viral replication), complications (pain, headache) and comorbidities (hypertension, obesity, diabetes). The constituent herbs of these CMs and their chemical ingredients were from the Traditional Chinese Medicine Information Database. The experimentally-determined targets and the activity values of the chemical ingredients of these CMs were from the Natural Product Activity and Species Source Database. The approved and clinical trial drugs against these targets were searched from the Therapeutic Target Database and DrugBank Database. Pathways of the targets was obtained from Kyoto Encyclopedia of Genes and Genomes and additional literature search. RESULTS Overall, 9 CMs modulated 6 targets discovered by the COVID-19 target discovery studies, 8 and 11 CMs modulated 8 and 6 targets of the approved or clinical trial drugs for the treatment of the major COVID-19 complications and comorbidities, respectively. CONCLUSION The coordinated actions of each NHCC-recommended CM against a few targets of the major COVID-19 pathophysiology, complications and comorbidities, partly have common mechanisms with the conventional medicines.
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COMPARATIVE EVALUATION AND PROGNOSTIC UTILITY OF NEURONAL INJURY BIOMARKERS IN COVID-19 PATIENTS: A PROSPECTIVE STUDY.
Vrettou, CS, Vassiliou, AG, Pratikaki, M, Keskinidou, C, Tsipilis, S, Gallos, P, Jahaj, E, Orfanos, SE, Kotanidou, A, Dimopoulou, I
Shock (Augusta, Ga.). 2022;(6):507-513
Abstract
Background : COVID-19 disease severity markers include mostly molecules related to not only tissue perfusion, inflammation, and thrombosis, but also biomarkers of neural injury. Clinical and basic research has demonstrated that SARS-COV-2 affects the central nervous system. The aims of the present study were to investigate the role of neural injury biomarkers and to compare them with inflammatory markers in their predictive ability of mortality. Methods : We conducted a prospective observational study in critically ill patients with COVID-19 and in a cohort of patients with moderate/severe disease. S100b, neuron-specific enolase (NSE), and inflammatory markers, including soluble urokinase plasminogen activator receptor (suPAR), were measured on intensive care unit or ward admission, respectively. Statistical comparisons between patient groups were performed for all biomarkers under investigation. Correlations between different biomarkers were tested with Spearman correlation coefficient. Receiver operating characteristic curves were plotted using mortality as the classification variable and the biomarker levels on admission as the prognostic variables. Results : A total of 70 patients with COVID-19 were included in the final analysis. Of all studied biomarkers, s100b had the best predictive ability for death in the intensive care unit, with an area under the curve of 0.73 (0.61-0.83), P = 0.0003. S100b levels correlated with NSE, interleukin (IL)-8, and IL-10 (0.27 < rs < 0.37, P < 0.05), and tended to correlate with suPAR ( rs = 0.26, P = 0.05), but not with the vasopressor dose ( P = 0.62). Conclusion : Among the investigated biomarkers, s100b demonstrated the best predictive ability for death in COVID-19 patients. The overall biomarker profile of the patients implies direct involvement of the nervous system by the novel coronavirus.
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Prospective predictive performance comparison between clinical gestalt and validated COVID-19 mortality scores.
Soto-Mota, A, Marfil-Garza, BA, Castiello-de Obeso, S, Martinez Rodriguez, EJ, Carrillo Vazquez, DA, Tadeo-Espinoza, H, Guerrero Cabrera, JP, Dardon-Fierro, FE, Escobar-Valderrama, JM, Alanis-Mendizabal, J, et al
Journal of investigative medicine : the official publication of the American Federation for Clinical Research. 2022;(2):415-420
Abstract
Most COVID-19 mortality scores were developed at the beginning of the pandemic and clinicians now have more experience and evidence-based interventions. Therefore, we hypothesized that the predictive performance of COVID-19 mortality scores is now lower than originally reported. We aimed to prospectively evaluate the current predictive accuracy of six COVID-19 scores and compared it with the accuracy of clinical gestalt predictions. 200 patients with COVID-19 were enrolled in a tertiary hospital in Mexico City between September and December 2020. The area under the curve (AUC) of the LOW-HARM, qSOFA, MSL-COVID-19, NUTRI-CoV, and NEWS2 scores and the AUC of clinical gestalt predictions of death (as a percentage) were determined. In total, 166 patients (106 men and 60 women aged 56±9 years) with confirmed COVID-19 were included in the analysis. The AUC of all scores was significantly lower than originally reported: LOW-HARM 0.76 (95% CI 0.69 to 0.84) vs 0.96 (95% CI 0.94 to 0.98), qSOFA 0.61 (95% CI 0.53 to 0.69) vs 0.74 (95% CI 0.65 to 0.81), MSL-COVID-19 0.64 (95% CI 0.55 to 0.73) vs 0.72 (95% CI 0.69 to 0.75), NUTRI-CoV 0.60 (95% CI 0.51 to 0.69) vs 0.79 (95% CI 0.76 to 0.82), NEWS2 0.65 (95% CI 0.56 to 0.75) vs 0.84 (95% CI 0.79 to 0.90), and neutrophil to lymphocyte ratio 0.65 (95% CI 0.57 to 0.73) vs 0.74 (95% CI 0.62 to 0.85). Clinical gestalt predictions were non-inferior to mortality scores, with an AUC of 0.68 (95% CI 0.59 to 0.77). Adjusting scores with locally derived likelihood ratios did not improve their performance; however, some scores outperformed clinical gestalt predictions when clinicians' confidence of prediction was <80%. Despite its subjective nature, clinical gestalt has relevant advantages in predicting COVID-19 clinical outcomes. The need and performance of most COVID-19 mortality scores need to be evaluated regularly.
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Meta-analysis of arbidol versus lopinavir/ritonavir in the treatment of coronavirus disease 2019.
Yu, M, Wang, DC, Li, S, Lei, YH, Wei, J, Huang, LY
Journal of medical virology. 2022;(4):1513-1522
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OBJECTIVES To systematically evaluate the efficacy and safety of arbidol and lopinavir/ritonavir (LPV/r) in the treatment of coronavirus disease 2019 (COVID-19) using a meta-analysis method. METHODS The China Knowledge Network, VIP database, WanFang database PubMed database, Embase database, and Cochrane Library were searched for a collection of comparative studies on arbidol and lopinavir/ritonavir in the treatment of COVID-19. Meta-analysis was used to evaluate the efficacy and safety of Arbidol and lopinavir/ritonavir in the treatment of COVID-19. RESULTS The results of the systematic review indicated that Arbidol had a higher positive-to-negative conversion rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid on Day 7 (p = 0.03), a higher positive-to-negative conversion rate of SARS-CoV-2 nucleic acid on Day 14 (p = 0.006), a higher improvement rate of chest computed tomography on Day 14 (p = 0.02), a lower incidence of adverse reactions (p = 0.002) and lower rate of mortality (p = 0.007). There was no difference in the rate of cough disappearance on Day 14 (p = 0.24) or the rate of severe/critical illness (p = 0.07) between the two groups. CONCLUSIONS Arbidol may be superior to lopinavir/ritonavir in the treatment of COVID-19. However, due to the small number of included studies and the number of patients, high-quality multicenter large-sample randomized double-blind controlled trials are still needed for verification.
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Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.
Anderson, EJ, Creech, CB, Berthaud, V, Piramzadian, A, Johnson, KA, Zervos, M, Garner, F, Griffin, C, Palanpurwala, K, Turner, M, et al
The New England journal of medicine. 2022;(18):1673-1687
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BACKGROUND The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown. METHODS Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 3:1 ratio to receive two 25-μg injections of mRNA-1273 or placebo, administered 28 days apart. The primary objectives were to evaluate the safety and reactogenicity of the vaccine and to determine whether the immune response in these children was noninferior to that in young adults (18 to 25 years of age) in a related phase 3 trial. Secondary objectives were to determine the incidences of Covid-19 and severe acute respiratory syndrome coronavirus 2 infection after administration of mRNA-1273 or placebo. RESULTS On the basis of safety and immunogenicity results in part 1 of the trial, the 25-μg dose was evaluated in part 2. In part 2, 3040 children 2 to 5 years of age and 1762 children 6 to 23 months of age were randomly assigned to receive two 25-μg injections of mRNA-1273; 1008 children 2 to 5 years of age and 593 children 6 to 23 months of age were randomly assigned to receive placebo. The median duration of follow-up after the second injection was 71 days in the 2-to-5-year-old cohort and 68 days in the 6-to-23-month-old cohort. Adverse events were mainly low-grade and transient, and no new safety concerns were identified. At day 57, neutralizing antibody geometric mean concentrations were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds, as compared with 1391 (95% CI, 1263 to 1531) among young adults, who had received 100-μg injections of mRNA-1273, findings that met the noninferiority criteria for immune responses for both age cohorts. The estimated vaccine efficacy against Covid-19 was 36.8% (95% CI, 12.5 to 54.0) among 2-to-5-year-olds and 50.6% (95% CI, 21.4 to 68.6) among 6-to-23-month-olds, at a time when B.1.1.529 (omicron) was the predominant circulating variant. CONCLUSIONS Two 25-μg doses of the mRNA-1273 vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults. (Funded by the Biomedical Advanced Research and Development Authority and National Institute of Allergy and Infectious Diseases; KidCOVE ClinicalTrials.gov number, NCT04796896.).
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Comparison of renin-angiotensin-aldosterone system inhibitors with other antihypertensives in association with coronavirus disease-19 clinical outcomes.
Bezabih, YM, Bezabih, A, Alamneh, E, Peterson, GM, Bezabhe, W
BMC infectious diseases. 2021;(1):527
Abstract
BACKGROUND Reports on the effects of renin-angiotensin-aldosterone system (RAAS) inhibitors on the clinical outcomes of coronavirus disease-19 (COVID-19) have been conflicting. We performed this meta-analysis to find conclusive evidence. METHODS We searched published articles through PubMed, EMBASE and medRxiv from 5 January 2020 to 3 August 2020. Studies that reported clinical outcomes of patients with COVID-19, stratified by the class of antihypertensives, were included. Random and fixed-effects models were used to estimate pooled odds ratio (OR). RESULTS A total 36 studies involving 30,795 patients with COVID-19 were included. The overall risk of poor patient outcomes (severe COVID-19 or death) was lower in patients taking RAAS inhibitors (OR = 0.79, 95% CI: [0.67, 0.95]) compared with those receiving non-RAAS inhibitor antihypertensives. However, further sub-meta-analysis showed that specific RAAS inhibitors did not show a reduction of poor COVID-19 outcomes when compared with any class of antihypertensive except beta-blockers (BBs). For example, compared to calcium channel blockers (CCBs), neither angiotensin-I-converting enzyme inhibitors (ACEIs) (OR = 0.91, 95% CI: [0.67, 1.23]) nor angiotensin-II receptor blockers (ARBs) (OR = 0.90, 95% CI: [0.62, 1.33]) showed a reduction of poor COVID-19 outcomes. When compared with BBs, however, both ACEIs (OR = 0.85, 95% CI: [0.73, 0.99) and ARBs (OR = 0.72, 95% CI: [0.55, 0.94]) showed an apparent decrease in poor COVID-19 outcomes. CONCLUSIONS RAAS inhibitors did not increase the risk of mortality or severity of COVID-19. Differences in COVID-19 clinical outcomes between different class of antihypertensive drugs were likely due to the underlying comorbidities for which the antihypertensive drugs were prescribed, although adverse effects of drugs such as BBs could not be excluded.
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Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection: The INTERCOVID Multinational Cohort Study.
Villar, J, Ariff, S, Gunier, RB, Thiruvengadam, R, Rauch, S, Kholin, A, Roggero, P, Prefumo, F, do Vale, MS, Cardona-Perez, JA, et al
JAMA pediatrics. 2021;(8):817-826
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IMPORTANCE Detailed information about the association of COVID-19 with outcomes in pregnant individuals compared with not-infected pregnant individuals is much needed. OBJECTIVE To evaluate the risks associated with COVID-19 in pregnancy on maternal and neonatal outcomes compared with not-infected, concomitant pregnant individuals. DESIGN, SETTING, AND PARTICIPANTS In this cohort study that took place from March to October 2020, involving 43 institutions in 18 countries, 2 unmatched, consecutive, not-infected women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge. EXPOSURES COVID-19 in pregnancy determined by laboratory confirmation of COVID-19 and/or radiological pulmonary findings or 2 or more predefined COVID-19 symptoms. MAIN OUTCOMES AND MEASURES The primary outcome measures were indices of (maternal and severe neonatal/perinatal) morbidity and mortality; the individual components of these indices were secondary outcomes. Models for these outcomes were adjusted for country, month entering study, maternal age, and history of morbidity. RESULTS A total of 706 pregnant women with COVID-19 diagnosis and 1424 pregnant women without COVID-19 diagnosis were enrolled, all with broadly similar demographic characteristics (mean [SD] age, 30.2 [6.1] years). Overweight early in pregnancy occurred in 323 women (48.6%) with COVID-19 diagnosis and 554 women (40.2%) without. Women with COVID-19 diagnosis were at higher risk for preeclampsia/eclampsia (relative risk [RR], 1.76; 95% CI, 1.27-2.43), severe infections (RR, 3.38; 95% CI, 1.63-7.01), intensive care unit admission (RR, 5.04; 95% CI, 3.13-8.10), maternal mortality (RR, 22.3; 95% CI, 2.88-172), preterm birth (RR, 1.59; 95% CI, 1.30-1.94), medically indicated preterm birth (RR, 1.97; 95% CI, 1.56-2.51), severe neonatal morbidity index (RR, 2.66; 95% CI, 1.69-4.18), and severe perinatal morbidity and mortality index (RR, 2.14; 95% CI, 1.66-2.75). Fever and shortness of breath for any duration was associated with increased risk of severe maternal complications (RR, 2.56; 95% CI, 1.92-3.40) and neonatal complications (RR, 4.97; 95% CI, 2.11-11.69). Asymptomatic women with COVID-19 diagnosis remained at higher risk only for maternal morbidity (RR, 1.24; 95% CI, 1.00-1.54) and preeclampsia (RR, 1.63; 95% CI, 1.01-2.63). Among women who tested positive (98.1% by real-time polymerase chain reaction), 54 (13%) of their neonates tested positive. Cesarean delivery (RR, 2.15; 95% CI, 1.18-3.91) but not breastfeeding (RR, 1.10; 95% CI, 0.66-1.85) was associated with increased risk for neonatal test positivity. CONCLUSIONS AND RELEVANCE In this multinational cohort study, COVID-19 in pregnancy was associated with consistent and substantial increases in severe maternal morbidity and mortality and neonatal complications when pregnant women with and without COVID-19 diagnosis were compared. The findings should alert pregnant individuals and clinicians to implement strictly all the recommended COVID-19 preventive measures.