Prospective Observational Cohort Study of Serological Responses to COVID-19 Vaccines in Pediatric Kidney Transplant Recipients at a Single Institution

Background. Pediatric kidney transplant recipients (PKTR) are at risk of poor outcomes from COVID-19. Data on serologic responses to COVID-19 vaccines in PKTR remain sparse. We characterized the magnitude, breadth, and longevity of SARS-CoV-2 spike protein binding antibody responses in PKTR. Methods. This single institution, prospective observational study enrolled PKTR presenting to a transplant clinic for routine care who had received or were eligible to receive a COVID-19 vaccine. Demographic data, history of prior COVID-19, and vaccination details were collected. Plasma samples obtained from standard-of-care residual specimens were analyzed for SARS-CoV-2 spike variant IgG using the MesoScale Discovery V-PLEX platform, which quantitatively measures antibodies to SARS-CoV-2 full-length spike wild-type (Wuhan-hu-1), Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), Gamma (P.1), and Omicron (B.1.1.529;BA.1) variants. Vaccine time points with > 5 samples available were analyzed. Geometric mean titers (GMTs) were calculated and log-transformed titers were compared using one-way ANOVA with Tukey's post-hoc comparisons test. Results. 61 PKTR enrolled (Table1);47 (77%) received at least 1 dose of COVID-19 vaccine in transplant clinic. 47 (77%) PKTR had at least one sample available for analysis, but serial specimens were lacking for many. By 6 months post-dose 2 of COVID-19 mRNA vaccination, spike (Wuhan-hu-1) IgG titers had waned to prevaccination levels (GMT 24 vs 47 binding antibody units (BAU)/mL, P=0.988). Administration of a 3rd dose of mRNA vaccine significantly boosted IgG antibodies (GMT 492 BAU/mL, P=0.007), and titers were maintained at 3 months (GMT 656 BAU/mL, P=0.001) but gradually waned by 6 months (GMT 223 BAU/mL, P=0.070). Administration of a 4th dose elicited a non-significant increase in titers (GMT 905 BAU/mL, P=0.870). Binding IgG antibodies to SARS-CoV-2 variant spike proteins post-vaccination were not significantly different from Wuhan spike. Conclusion. In this cohort of PKTR, a 3rd dose of COVID-19 mRNA vaccine significantly boosted broadly cross-reactive binding IgG antibodies to SARS-CoV-2 spike variants, including Omicron. Decreasing titers at 6 months post-dose 3 raise concern for waning protective immunity and support 4th dose vaccination.

Cook and Move for Your Life: A pilot study of an online intervention to improve diet and physical activity among breast cancer survivors

Purpose: The Cook & Move for Your Life randomized pilot study assessed the feasibility and relative efficacy of two dose levels of a remotely-delivered diet and physical activity (PA) intervention for breast cancer (BC) survivors. Methods: Women with a history of stage 0-III BC who were >60 days post-treatment, ate <5 servings per day of fruits/vegetables or engaged in <150 minutes per week of moderate to vigorous physical activity (MVPA), and had smartphone or computer access were enrolled. Participants were randomized to receive one of two doses of an online diet and PA didactic and experiential program, with outcomes measured at 6 months. The low-dose arm received a single 2-hour Zoom session delivered by a dietitian, a chef, a culinary educator, and an exercise physiologist;the high-dose arm received 12 2-hour Zoom sessions over 6 months. All participants received weekly motivational text messages, a Fitbit to self-monitor PA, and study website access. The primary objective was to evaluate overall feasibility based on accrual, adherence, and retention. Prespecified feasibility endpoints were 75% retention at 6 months and 60% of high-dose arm participants attending at least 8 of the 12 sessions. Secondary objectives were to compare high vs. low dose intervention effects on 6-month changes in fruit/vegetable servings per day (24-hour dietary recall), MVPA minutes per week (accelerometry), and blood and stool biomarkers.Results: From December 2019 to January 2021, 74 women were accrued. On average, women were 57.9 years old, 4.8 years post-diagnosis, with body mass index of 29.1 kg/m2 . Most were nonHispanic white (89.2%), 51.4% were diagnosed at stage I, and 40.5% were on endocrine therapy. Questionnaire and biospecimen data collection at 6-months were completed for 93.2% and 83.8% of the sample, respectively. In the low-dose arm (n=36), 94.4% of participants attended the single class, while in the high-dose arm (n=38) 84.2% of participants attended at least 8 of the 12 sessions live or via video archived on the website (mean 9.4 sessions). On average over the 6-month intervention period, participants responded to 71.5% of the text messages, 73.0% wore their Fitbit device ≥50% of the time, and 77.0% accessed the study website. Mean vegetable intake increased by 1 serving per day among women in the high-dose arm and decreased slightly among women in the low-dose arm (P=0.03). Changes in fruit/vegetable intake and MVPA varied little by arm. Blood and stool biomarker analyses are ongoing. Conclusion: We successfully conducted a remotely-delivered diet and PA intervention for BC survivors with high accrual, adherence, and retention during the COVID-19 pandemic. Women in the high-dose arm increased vegetable intake relative to the low-dose arm. Future research will refine and test the intervention in a larger and more diverse study population.

Predictors of objectively-measured sedentary time during the COVID-19 pandemic among breast cancer survivors participating in a diet and physical activity intervention

Purpose of the study: The purpose of this study was to investigate the predictors of objectively-measured sedentary time (ST) among breast cancer (BC) survivors who were 60 days post-treatment and were initiating participation in an intervention to improve diet and physical activity (PA) during the early phase of the COVID-19 pandemic. Methods: Cook and Move for Your Life (CMFYL) was a pilot and feasibility study of stage 0-III BC survivors testing the effects of a remotely-delivered and remotely-assessed nutrition and PA intervention. Women were ≥60 days post-treatment (current endocrine therapy allowed), consumed <5 servings of fruits/vegetables per day and/or engaged in <150 minutes/week of moderate to vigorous physical activity (MVPA). Hip-worn Actigraph GT3X accelerometers measured ST for 7 consecutive days at baseline. ST was defined as minutes/day (continuous) based on the Troiano cutpoint (<100 counts/minute), during awake (6am-11pm) wear time, and non-wear was identified using the Choi algorithm on the vector magnitude counts/minute. Multivariable linear regression models adjusting for wear time (average minutes/day) and minutes of MVPA/day were used to examine whether the following factors were predictors of ST at baseline: self-reported demographics, psychosocial factors (assessed via PROMIS Physical Function and PROMIS Anxiety forms), diet quality (Healthy Eating Index 2015 score), caloric intake (calories/day), and fruit and vegetable intake (servings/day). Results: Among the 84 women included in this analysis who had actigraphy measurements at baseline, the average ST/day was 684±79 minutes. On average, women were 58±10 years in age and most self-identified as non-Hispanic white (87%). The average time since diagnosis at time of enrollment was 4.5 years and 59% of women were receiving endocrine therapy at baseline. Adjusted models show that participants with a college degree had 24.7 (95%CI 2.0, 47.4) more minutes of ST than those with less than a college degree, and for every 1-point increase in PROMIS Physical Function scores participants had 2.5 (95%CI -4.9, -0.2) fewer minutes of ST. Conclusion: In a sample of BC survivors enrolled in a diet and PA intervention, higher level of education and poorer physical function were associated with higher ST during the early phase of the COVID-19 pandemic. These findings provide preliminary insight into factors associated with ST. Future work will investigate how these factors influence change in ST after participation in the CMFYL intervention.

Implementation of an electronic medical record based transition of care program from the emergency room to gastroenterology clinics improves followup

Introduction: Patients discharged from the emergency department (ED) requiring outpatient follow-up are at risk for increased rates of adverse events, return visits to the ED, and hospitalization when they do not follow-up. This highlights preliminary results from a pilot GI Transitionof- Care (GI TOC) program. Methods: A retrospective single center cohort study was performed. ED patients referred for outpatient GI follow-up were examined from before and after implementation of the GI TOC program. The GI TOC program at Stony Brook University Hospital (initiated July 2019) involved a message generated by ED referral orders to GI clinic. This message pool was reviewed by a Gastroenterologist who triaged each patient for urgency and directed patients to appropriate GI subspecialty clinics. The GI office then called patients to facilitate appointment scheduling. Patients discharged from the ED prior GI TOC were simply given the GI office phone number. Primary outcome: percentage of patients discharged from the ED for GI follow-up who successfully completed a follow-up GI appointment. Secondary outcomes included rates of appointment scheduling and percent of diagnostic testing and therapeutic GI procedures generated as a result. Results: There were 233 GI TOC patients during the 5-month period from August-December 2020. 942 ED patients were referred to GI over a 5-month period from February-June 2019. These time periods were chosen to minimize the bias introduced by the COVID19 pandemic. GI TOC patients were statistically more likely to schedule GI appointments (48.93% vs 21.97%, p<0.01) and show up (37.77% vs 20.91%, p<0.01) when compared to pre-GI TOC patients. Of the patients who showed up to appointments, pre-GI TOC patients were more likely to have additional diagnostic testing (e.g. labs and imaging) when compared to GI TOC patients (80.71% vs 64.77%, p<0.01). However, GI TOC patients had a higher percentage of endoscopic procedures ordered when compared to pre-GI TOC patients (85.96% vs 64.41%, p<0.01). Conclusion: Patient navigation through a GI TOC program can result in improved outpatient GI follow-up. Expediting patient care, GI TOC programs can decrease repeat ED visits and costly hospitalizations. GI provider review of consults for urgency and appropriate subspecialty clinics can introduce increased efficiency in patient care. GI TOC can also result in increased downstream revenue for the GI practice through procedure generation..

Mesenchymal stem cells for the treatment of covid-19: Why and when they should be used?

COVID-19 is a pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which caused deaths of more than 300.000 people around the world within the first few months of 2020. SARS-CoV-2 uses ACE2 receptors to infect respiratory system cells and may cause pneumonia and severe lung damage. The virus can also spread other organs rapidly via ACE2 expressing endothelial cells and cause coagulopathy, and further damage to the organs. Another and probably more harmful effect of the virus is the overreaction of the immune system leading to hyperinflammation causing multiple organ failure and death. Therefore COVID-19 can be considered as a viral infection causing auto-immune disorders. Currently, no vaccine or effective pharmacological treatment established for the disease. On the other hand, Mesenchymal Stem Cells (MSCs) possess anti- inflammatory and immune-regulatory effects along with their regenerative abilities. In this article, we thoroughly evaluate the COVID-19 pandemic and the damage mechanisms on the cellular level which can be ameliorated with the cellular therapies. We also gathered previous and ongoing stem cell clinical trial data from diseases with similar symptoms. All these accumulated data and current clinical trial results indicate that the cellular therapies could be the most effective treatment option for COVID-19 patients to ameliorate the damaged tissues and save lives. © Nova Science Publishers, Inc.

Utilization of a low-volume bowel preparation in the inpatient setting: A retrospective study

INTRODUCTION: Large volume preparations that are polyethylene glycol based (GoLYTELY and MiraLAX) are the mainstay of bowel preparation regiment at many institutions. Studies have shown that patients prefer lower volume preparations compared to the standard 4 Liter GoLYTELY. Although data has been collected on low volume bowel preparation efficacy in the outpatient setting for elective colonoscopy, there is little data on low volume bowel preparations in the inpatient setting. We performed a retrospective review of patients who received Clenpiq, a low volume bowel preparation for colonoscopies at our institution. METHODS: A retrospective review from the past year was done to assess which patients underwent bowel preparation with Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) at a single institution. On the evening prior to the colonoscopy, patients were instructed to drink 2 bottles of Clenpiq (160 mL solution) six hours apart. Each bottle was followed by 32 oz ounces of clear liquids. Contraindications included severe renal impairment (CrCl<30 mL/min), GI obstruction and ileus, bowel perforation, colitis, gastric retention, hypersensitivity to compounds of formula. RESULTS: 10 patients were analyzed (mean age 57.5, eight female, two male). 7 patients completed the preparation, while 2 patients could not complete it due to nausea / vomiting. There were 0 cases that needed to be rescheduled due to inadequate bowel preparation.±out of 8 cases were reported to be good or excellent bowel preparation per the endoscopist report. CONCLUSION: The inpatient hospital setting compared with the ambulatory setting, has been associated with almost a two-fold higher risk of inadequate bowel preparation prior to colonoscopy. Inadequate bowel preparation is associated with increased risk of missed lesions, resulting in repeat and lengthier procedures. From our limited data, the majority of patients that took Clenpiq prior to colonoscopy, were able to fully finish the prep, had adequate prep and were able to tolerate it without any adverse reactions. As a result of the COVID-19 pandemic, and major limitations on electivecases, we will pursue prospective analysis of cases in the future. Further research should be done to compare ClenPiq with GoLytely as an alternative to routine bowel prep in hospitalized patients.

Pregnancy and transaminitis in the COVID-19 era

INTRODUCTION: Liver complications associated with the novel corona virus, COVID-19 (SARSCoV- 2) are well-described phenomena occurring in approximately 60% of infected patients. The degree and extent in the level of transaminitis is not yet well defined. In the evaluation of transaminitis in pregnant patients, consideration of the differential diagnoses is important in order to provide appropriate timely treatment and management. Determining the exact etiology for transaminitis in the pregnant patient with COVID-19 is particularly challenging given other competing diagnosis in this patient population. We present a case of a pregnant woman with acute liver enzyme elevation in the setting of COVID-19 infection. CASE DESCRIPTION/METHODS: A 34 year old female with COVID-19 presented at 33 weeks twin gestation with right upper quadrant pain, vomiting for 2 days and acute respiratory distress which improved with supplemental oxygen. Initial labs showed elevated inflammatory markers, mildly elevated liver enzymes (AST 102, ALT 53 IU/L), low platelets (139 K/uL), lactate dehydrogenase was 375 IU/L, and INR was 1.0. Total bilirubin was normal. An abdominal ultrasound demonstrated cholelithiasis without evidence of cholecystitis, patent portal and hepatic veins, and no biliary ductal dilation. The next day, her liver enzymes increased (ALT;119 IU/L and AST;228 IU/L), and LDH rose to 750 IU/L while vital signs were unchanged. She was treated with N-acetyl-cysteine (non-acetaminophen-induced liver failure protocol) without improvement. The next day her liver enzymes peaked (ALT;307 IU/L and AST;641 IU/L). Due to rising liver enzymes, increased abdominal pain she underwent an emergency c-section to minimize maternal and fetal risk. Postoperatively, her ALT and AST down trended. On post-op day 4, aminotransferases markedly improved (AST of 20 IU/L, ALT of 49 IU/L), patients symptoms improved and patient was discharged home. DISCUSSION: Clinical presentation and associated liver complications of COVID-19 infection are not well described. Due to the rapid global spread of COVID-19, prompt identification of associated liver test abnormalities from other causes especially in pregnant patients is vital. It is also important to consider that COVID-19 may cause severe acute viral hepatitis rather than a mild elevation in liver enzymes in pregnant patients, possibly exacerbating underlying conditions such as pre-eclampsia or HELLP syndrome.