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2.
JAMA Netw Open ; 5(4):e227852, 2022.
Article in English | PubMed | ID: covidwho-1798065

ABSTRACT

IMPORTANCE: SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. OBJECTIVE: To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021. INTERVENTIONS: Patients stratified by age, history of hypertension, and disease severity were centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo. Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone. MAIN OUTCOMES AND MEASURES: The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. Secondary end points were time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference range, maximum severity of COVID-19, and the composite end point at 30 days. RESULTS: The trial was stopped for futility after the planned interim analysis, at which time there were 96 evaluable patients, including 62 patients randomized to the degarelix group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%];P = .67). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04397718.

3.
Cancer Nurs ; 2022.
Article in English | PubMed | ID: covidwho-1794982

ABSTRACT

BACKGROUND: Men receiving androgen deprivation therapy (ADT) for prostate cancer (PC) are at risk for cardiovascular comorbidities and cognitive changes. Interventional research involves in-person assessment of physical fitness/activity and cognitive function, which has been negatively affected by the COVID-19 pandemic. Androgen deprivation therapy-related hot flashes and nocturia increase risk for insomnia. Insomnia is associated with fatigue and may exacerbate ADT-related cognitive changes. OBJECTIVES: The purpose of this mixed-methods pilot was to (1) determine feasibility/acceptability of remotely assessing physical fitness/activity, cognitive function, and sleep;(2) deliver telehealth cognitive behavioral training for insomnia (teleCBT-I) to improve sleep;and (3) garner qualitative feedback to refine remote procedures and teleCBT-I content. METHODS: Fifteen men with PC receiving ADT completed a 4-week teleCBT-I intervention. Videoconferencing was used to complete study assessments and deliver the weekly teleCBT-I intervention. RESULTS: Self-report of sleep quality improved (P < .001) as did hot flash frequency (P = .04) and bother (P = .025). Minimal clinically important differences were detected for changes in insomnia severity and sleep quality. All sleep logs indicated improvement in sleep efficiency. Remote assessment of fitness/cognitive function was demonstrated for 100% of participants. Sufficient actigraph wear time allowed physical activity/sleep assessment for 80%. Sleep actigraphy did not demonstrate significant changes. CONCLUSIONS: Remote monitoring and teleCBT-I are feasible/acceptable to men with PC on ADT. Further research to confirm teleCBT-I efficacy is warranted in this population. IMPLICATIONS FOR PRACTICE: Preliminary efficacy for teleCBT-I interventions was demonstrated. Remote assessments of physical fitness/activity, sleep, and cognitive function may enhance clinical trial access for rural or economically disadvantaged PC survivors.

4.
Journal of Heart & Lung Transplantation ; 41(4):S209-S209, 2022.
Article in English | Academic Search Complete | ID: covidwho-1783398

ABSTRACT

SRTR data currently suggests that induction therapy in simultaneous heart-kidney transplantation (SHKT) with rabbit antithymoglobulin (ATG) provides survival advantage compared to interleukin-2 receptor antagonist (IL2-RA). We are reporting the outcomes of recipients with SHKT treated with IL2-RA as induction therapy. This is a single center, retrospective study of 26 patients who received SHKT at our institution from Dec 2018 to Oct 2021. A multidisciplinary team composed of heart and kidney transplant medical and surgical members determined appropriate recipient-donor SHKT candidate pairs. The majority of patients received IL2-RA induction therapy, and all patients received triple immunosuppression therapy with prednisone, mycophenolate mofetil and tacrolimus. Adjustments in long term therapy were made in collaboration between the heart and kidney transplant teams. From Dec 2018 to Oct 2021, 26 patients underwent SHKT. 23 patients (88%) were male, the median age was 57 years, and 5.4% were ≥ 65 years. 18 patients (69%) had non ischemic cardiomyopathy and 24 patients (92%) had CKD (mean GFR ≤ 35%). 18 patients were listed Status 2 and 2 patient Status 5. One patient received a DCD donor and 12 patients (46%) received hep C donors. 25 patients (96%) received induction therapy with IL2-RA. During the first 3 months post-transplant, the only patient who received ATG had 7 severe infections;11 patients (44%) and 13 patients (52%) who received IL2 -RA had no infections and ≤ 4 mild infections, respectively. One patient died due to COVID 19 pneumonia complicated by multisystem organ failure. For a median follow up period of 410 (187-707) days, 8% patients in the IL2-RA induction cohort experienced a 2R/3A heart rejection, 8% patients remained on HD due to primary kidney graft non-function, and the survival rate was 96%. Compared with present literature, our data support the use of IL2- RA as an induction strategy in SHKT with excellent patient survival. [ FROM AUTHOR] Copyright of Journal of Heart & Lung Transplantation is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

5.
Obesity ; 29(SUPPL 2):189-190, 2021.
Article in English | EMBASE | ID: covidwho-1616053

ABSTRACT

Background: Individuals living in rural areas have higher obesity and obesity related co-morbidities than their urban counterparts. Understanding rural-urban differences associated with weight management may inform the development of effective weight management interventions for adults living in rural areas. Methods: The International Weight Control Registry (IWCR) is an online registry designed to assess factors contributing to successes and challenges with weight loss and weight loss maintenance across the world. We examined demographics, weight history and weight management strategies in a sample of urban and rural residents in the Midwestern U.S. (IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI). Participants were classified as rural or urban by the Rural-Urban Commuting Area Code. Analyses included Chi-square tests for proportions and independent t-test and Wilcoxon rank sum test for continuous variables. Results: The sample was 45% rural (n = 78 of a total N = 174) with a mean age of 50.3 years. Rural residents were more likely to be white, non-college graduates, and have lower family income compared with urban areas (p < 0.05). Rural and urban residents reported similar weight histories and strategies for weight management. Work-related physical activity was higher and weekday sitting time was lower in rural compared to urban residents (p < 0.01). These data could potentially be impacted by the relative number of residents working from home during COVID-19 (Urban: 59% vs. Rural: 37%, p < 0.05). Rural residents were more likely to report a lack of neighborhood walkability (p < 0.01) and healthy food availability (p < 0.05) compared with urban residents. Conclusions: These data suggest rural-urban differences in demographic characteristics, opportunity for leisure time physical activity, and the availability of heathy foods should be considered in the development of weight management interventions. The consistency of the observed findings will be evaluated at the regional, national and international levels as the size of the available sample in the IWCR increases.

6.
American Journal of Transplantation ; 21(SUPPL 4):566-567, 2021.
Article in English | EMBASE | ID: covidwho-1494484

ABSTRACT

Purpose: The rapid shift to telemedicine and remote monitoring of kidney transplant recipients (KTRs) during COVID-19 aimed to mitigate exposure risk for this vulnerable population. dd-cfDNA (AlloSure, CareDx Brisbane) is a well-established biomarker for surveillance of KTRs and is associated with allograft tissue injury, including immunological events such as acute rejection. Here we describe an innovative approach to remote surveillance for KTRs using mobile home phlebotomy during the pandemic. Methods: Pilot program of KTRs enrolled into the mobile home phlebotomy (RemoTraC) from March-November 2020. AlloSure dd-cfDNA was concomitantly performed with routine post-transplant laboratory studies at regular time intervals as per standard of care. Results: 159 KTRs were enrolled in the mobile phlebotomy program with 1421 draws completed during the surveillance period. Patient demographics are sum marized in Table 1. The median AlloSure dd-cfDNA level was 0.21% (IQR 0.12-0.42%). 25 for-cause biopsies were performed in patients monitored with mobile phlebotomy. 12 patients had biopsy proven rejections paired with AlloSure dd-cfDNA (1 borderline, 2 TCMR1A, 4 TCMR2A, 2 TCMR1B, 2 chronic active TCMR and 1 mixed AMR/TCMR). The median AlloSure dd-cfDNA was 0.5% (IQR 0.2-3.26%) in patients with active rejection compared to 0.14% (IQR 0.12-0.56%) in patients with no rejection (p=0.03). There was no difference in serum creatinine between the two groups (p=0.3). The median AlloSure dd-cfDNA levels in TCMR2A/1B and mixed AMR/TCR were 0.72 and 7.7% respectively. Conclusions: AlloSure dd-cfDNA can optimize post-transplant care by identifying patients at risk of allograft injury and rejection. This analysis demonstrates the feasibility of mobile phlebotomy for routine surveillance in combination with telehealth strategies during the unprecedented COVID-19 pandemic. In addition, utilization of dd-cfDNA helped clinicians direct limited resources during the pandemic for allograft biopsies when paired with standard clinical markers such as creatinine.

7.
American Journal of Transplantation ; 21(SUPPL 4):421, 2021.
Article in English | EMBASE | ID: covidwho-1494453

ABSTRACT

Purpose: COVID-19 infection is associated with 25% mortality in kidney transplant recipients (KTRs). Reduction of anti-metabolite immunosuppressants during the acute COVID-19 illness is a common approach in managing KTRs. This potentially increases the risk of allograft rejection in the setting of reduced immunosuppression. The optimal timing for safe reintroduction of immunosuppression remains unclear. Here we describe a novel approach of incorporating dd-cfDNA to safely titrate immunosuppression in patients with COVID-19. Methods: KTRs were monitored prospectively with dd-cfDNA beginning at the time of COVID-19 diagnosis or on discharge from acute care. If dd-cfDNA<1%, antimetabolite dosing was increased by 25% every two weeks. If dd-cfDNA>1% or a rapid relative change from baseline, antimetabolites were reintroduced at full dose provided the patient remained symptom free from COVID-19. Results: 58 KTRs (including 1 PAK) with COVID-19 infection were monitored with dd-cfDNA at the time of or following this diagnosis from March 2020 to January 2021. Demographics and directed treatments are summarized in Table 1. Median dd-cfDNA levels remained stable during longitudinal surveillance following COVID-19 (Figure 1A). 3/58 patients with COVID-19 and dd-cfDNA results available developed biopsy-proven rejection. One developed rejection at the time of COVID-19 diagnosis with elevated dd-cfDNA. 2/58 developed rejection in the setting of delayed re-introduction of antimetabolites due to clinical concerns (Figure 1B), however one did not have elevated dd-cfDNA. 10% of patients (n=6) had accelerated reintroduction of anti-metabolites due to dd-cfDNA levels>1% or rapid deviation from baseline. None of these patients developed rejection in the following months and dd-cfDNA levels decreased after immunosuppression reintroduction. Standard reintroduction of anti-metabolites with dd-cfDNA <1% was achieved with no associated episodes of rejection. Conclusions: dd-cfDNA presents a feasible adjunctive biomarker to guide immunosuppression titration in KTRs with confirmed COVID-19 and avoid allograft rejection during a time of increased immunological risk.

8.
The Sport Journal ; 23(57), 2020.
Article in English | CAB Abstracts | ID: covidwho-1408015

ABSTRACT

The COVID-19 pandemic has greatly impacted the budgets of college athletic departments at all levels. In response, some institutions have elected to eliminate specific team sports. This study examines how student-athletes respond when their schools announce the intent to eliminate their sports. The NCAA transfer portal can be used to identify the responses of affected student-athletes. For the team eliminations made in Spring/Summer 2020, the affected student-athletes tended to enter the NCAA transfer portal to attempt to find a new school to meet their athletic and academic goals. The actions were taken even though most schools announce the intent to honor the scholarships of affected student-athletes even with the elimination of their sports. Over 40% of NCAA Division I and II student-athletes receive partial or no athletic aid. These students are paying tuition and fees while competing in their sports. As schools study the possible elimination of team sports, they must be mindful to consider the total cost of eliminating a sport and not simply the reduction in the athletic budget. The presence of partial scholarships may make it advantageous to continue such sports to retain those student-athletes and the tuition and fees they pay.

9.
British Journal of Dermatology ; 185:89-90, 2021.
Article in English | Web of Science | ID: covidwho-1396221
10.
Trials ; 22(1): 431, 2021 Jul 05.
Article in English | MEDLINE | ID: covidwho-1298059

ABSTRACT

BACKGROUND: Therapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface protease. Pre-clinical and correlative data in humans suggest that anti-androgenic therapies can reduce the expression of TMPRSS2 on lung epithelium. Accordingly, we hypothesize that therapeutic targeting of androgen receptor signaling via degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, will suppress COVID-19 infection and ameliorate symptom severity. METHODS: This is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Enrolled patients must have documented infection with SARS-CoV-2 based on a positive reverse transcriptase polymerase chain reaction result performed on a nasopharyngeal swab and have a severity of illness of level 3-5 (hospitalized but not requiring invasive mechanical ventilation). Patients stratified by age, history of hypertension, and severity are centrally randomized 2:1 (degarelix: placebo). The composite primary endpoint is mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at 15 after randomization. Important secondary endpoints include time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a normal temperature, and the maximum severity of COVID-19 illness. Exploratory analyses aim to assess the association of cytokines, viral load, and various comorbidities with outcome. In addition, TMPRSS2 expression in target tissue and development of anti-viral antibodies will also be investigated. DISCUSSION: In this trial, we repurpose the FDA approved LHRH antagonist degarelix, commonly used for prostate cancer, to suppress TMPRSS2, a host cell surface protease required for SARS-CoV-2 cell entry. The objective is to determine if temporary androgen suppression with a single dose of degarelix improves the clinical outcomes of patients hospitalized due to COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov NCT04397718. Registered on May 21, 2020.


Subject(s)
COVID-19 , Veterans , Clinical Trials, Phase II as Topic , Hospitalization , Humans , Male , Multicenter Studies as Topic , Oligopeptides , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
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