Regulatory challenges of convalescent plasma collection during the evolving stages of COVID-19 pandemic in the United States.
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SUBMITTER: Hassan S
PROVIDER: S-EPMC8661755 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PURPOSE:This report describes initiation of apheresis capability in Liberia, Africa to support a clinical trial of convalescent plasma therapy for Ebola Virus Disease. METHODS:A bloodmobile was outfitted in the United States as a four-bed apheresis unit with capabilities including pathogen reduction, electronic blood establishment computer system, designated areas for donor counseling and laboratory testing, and onboard electrical power generation. After air transport to Liberia, the bloodmobile was positioned at ELWA Hospital, Monrovia, and connected to the hospital's power grid. Liberian staff were trained to conduct donor screening, which included questionnaire and onsite blood typing and transfusion transmitted infection (TTI) testing, and plasma collection and processing. RESULTS:The bloodmobile was operational within 3 weeks after arrival of the advance team. Of 101 donors who passed the pre-screening questionnaire, 32 were deferred. Twenty-eight of ninty-nine tested survivors were deferred for positive transfusion transmitted infection (TTI) tests; twenty-one were positive for hepatitis B, hepatitis C, or human immunodeficiency virus. The majority of donors had type O blood; all but one were Rh positive. Forty-three survivors donated at least once; eighty-nine apheresis attempts resulted in eighty-one successful collections. CONCLUSIONS:Apheresis capability was emergently established in Liberia to support an efficacy trial of Ebola Convalescent Plasma. Extensive cooperation among multinational team members, engineers, logisticians, and blood safety technical personnel at the operational site was required to surmount challenges to execution posed by logistical factors. The high proportion of positive TTI tests supported the use of a pathogen reduction system to enhance product safety. J. Clin. Apheresis 32:175-181, 2017. © 2016 Wiley Periodicals, Inc.
| S-EPMC5580942 | biostudies-literature
Project description:BackgroundThe US Food and Drug Administration authorized Convalescent Plasma (CCP) therapy for hospitalized COVID-19 patients via the Expanded Access Program (EAP) and the Emergency Use Authorization (EUA), leading to use in about 500,000 patients during the first year of the pandemic for the US.MethodsWe tracked the number of CCP units dispensed to hospitals by blood banking organizations and correlated that usage with hospital admission and mortality data.ResultsCCP usage per admission peaked in Fall 2020, with more than 40% of inpatients estimated to have received CCP between late September and early November 2020. However, after randomized controlled trials failed to show a reduction in mortality, CCP usage per admission declined steadily to a nadir of less than 10% in March 2021. We found a strong inverse correlation (r = -0.52, P = 0.002) between CCP usage per hospital admission and deaths occurring two weeks after admission, and this finding was robust to examination of deaths taking place one, two or three weeks after admission. Changes in the number of hospital admissions, SARS-CoV-2 variants, and age of patients could not explain these findings. The retreat from CCP usage might have resulted in as many as 29,000 excess deaths from mid-November 2020 to February 2021.ConclusionsA strong inverse correlation between CCP use and mortality per admission in the USA provides population level evidence consistent with the notion that CCP reduces mortality in COVID-19 and suggests that the recent decline in usage could have resulted in excess deaths.
| S-EPMC8043483 | biostudies-literature
Project description:The potential negative effects of the COVID-19 pandemic on health-compromising behaviors including overeating, processed food intake, and alcohol use have been well documented. However, it is possible the COVID-19 pandemic has had positive effects on some health-promoting behaviors like cooking and fruit and vegetable intake. The current study was a preregistered secondary data analysis using data from a U.S. national, crowdsourced study (n = 868) on eating behaviors during the early stages of the COVID-19 pandemic. The objectives of the current study were to compare levels of cooking, fruit and vegetable intake, and physical activity among U.S. adults during the early stages of the COVID-19 pandemic to pre-pandemic levels in reference groups of U.S. adults, and test whether subjective stress from the pandemic was associated with health-promoting behaviors by obesity status. During the early stages of the COVID-19 pandemic, participants cooked more often and ate 0.23 more cups of fruits and vegetables per day, but 28.8% fewer participants met federal physical activity guidelines. Greater COVID-19 stress was minimally to moderately associated with greater cooking, fruit and vegetable intake, and physical activity. The positive association between COVID-19 stress and fruit and vegetable intake was stronger for individuals with obesity. The COVID-19 pandemic might have encouraged U.S. adults, especially those at risk for complications, to engage in some health-promoting behaviors while creating barriers for other behaviors.
| S-EPMC8522304 | biostudies-literature
Project description:BackgroundThe current West Africa Ebola virus disease (EVD) outbreak has resulted in multiple individuals being medically evacuated to other countries for clinical management.MethodsWe report two patients who were transported from West Africa to the United States for treatment of EVD. Both patients received aggressive supportive care measures, as well as an investigational therapeutic (TKM-100802) and convalescent plasma.ResultsWhile one patient experienced critical illness with multi-organ failure requiring mechanical ventilation and renal replacement therapy, both patients recovered without serious long-term sequelae to date.ConclusionsIt is unclear what role the experimental drug and convalescent plasma had in the recovery of these patients. Prospective clinical trials are needed to delineate the role of investigational therapies in the care of patients with EVD.
| S-EPMC4542597 | biostudies-literature
Project description:Hepatitis A Virus Incidence Rates and Biomarker Dynamics for Plasma Donors, United States
| PRJEB48304 | ENA
Project description:BackgroundEmergency medicine (EM) physicians have been on the front line of the COVID-19 pandemic. This study aims to determine the impact of COVID-19 pandemic and other related factors such as resource availability and institutional support on well-being, burnout and job-satisfaction of EM physicians in the United States.MethodsA cross-sectional survey study of EM physicians was conducted through the Emergency Medicine Practice Research Network of the ACEP. The survey focused on resource adequacy, institutional support, well-being, and burnout. A total of 890 EM physicians were invited to participate. Both descriptive and risk adjusted, and multivariate regressions were performed with a statistical significance defined as p < 0.05.ResultsEM physicians' response rate was 18.7% (166) from 39 states. Burnout was reported by 74.7% (124) since the start of the pandemic. Factors contributing included work-related emotional strain and anxiety, isolation from family and friends, and increased workload. Those reporting inadequate resources felt ignored by their institutions (p < 0.0001). Physicians who felt there was inadequate institutional support, were also dissatisfied with patient care resources (p = 0.001). Physicians expressing job dissatisfaction were more likely to report feelings of burnout (p = 0.001).ConclusionEM physicians face greater burnout in the COVID-19 pandemic. This may be compounded by resource scarcity, psychological stress, isolation, and job dissatisfaction. Many of the survey respondents reported inadequate mental health services and resources. The findings of this study may help identify solutions to mitigate these issues.
| S-EPMC8016733 | biostudies-literature
Project description: Not available
| S-EPMC8242651 | biostudies-literature
Project description:BackgroundThe United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma.Methods and findingsMayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects.ConclusionsThese results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease.Trial registrationClinicalTrials.gov NCT#: NCT04338360.
| S-EPMC8730442 | biostudies-literature
Project description:Kratom (Mitragyna speciosa, Korth.) is an evergreen tree that is indigenous to Southeast Asia. When ingested, kratom leaves or decoctions from the leaves have been reported to produce complex stimulant and opioid-like effects. For generations, native populations in Southeast Asia have used kratom products to stave off fatigue, improve mood, alleviate pain and manage symptoms of opioid withdrawal. Despite the long history of kratom use in Asia, it is only within the past 10-20 years that kratom has emerged as an important herbal agent in the United States, where it is being used for the self-treatment of pain, opioid withdrawal symptoms, and mood disorders. The increase in the use of kratom in the United States has coincided with the serious epidemic of opioid abuse and dependence. Since 2015, efforts to restrict access to prescription opioids have resulted in a marked increase in the use of "street" opioids such as heroin and illicit fentanyl. At the same time, many patients with chronic pain conditions or opioid use disorder have been denied access to appropriate medical help. The lack of access to care for patients with chronic pain and opioid use disorder has been magnified by the emergence of the COVID-19 pandemic. In this report, we highlight how these converging factors have led to a surge in interest in kratom as a potential harm reduction agent in the treatment of pain and opioid use disorder.
| S-EPMC8427750 | biostudies-literature
Project description:The Department of Health and Human Services National Blood Collection and Utilization Survey (NBCUS) has been conducted biennially since 1997. Data are used to estimate national blood collection and utilization.The 2013 Department of Health and Human Services NBCUS is a cross-sectional survey of all US blood collection centers and hospitals as listed in the 2012 American Hospital Association Annual Survey database that perform at least 100 inpatient surgical procedures annually. The study objective was to estimate, with 95% confidence intervals (CIs), the number of blood and blood components collected and transfused in the United States.In 2013, a total of 14,237,000 whole blood and apheresis red blood cell (RBC) units (95% CI, 13,639,000-14,835,000) were collected with 13,395,000 available for transfusion. Of these, 13,180,000 (95% CI, 12,389,000-13,972,000) whole blood and RBC units were transfused. This represented a 4.4% decline in the number of transfused units compared to 2011. Outdated (i.e., expired without being transfused) whole blood and RBC units declined by 17.3%. Apheresis (2,318,000; 95% CI, 2,154,000-2,482,000) and whole blood-derived platelet (PLT; 130,000; 95% CI, 23,000-237,000) distribution declined in 2013. Total PLT transfusions increased in 2013 (2,281,000) in comparison to 2011 (2,169,000). Total plasma units distributed (4,338,000) and transfused (3,624,000) declined.Both blood collection and utilization have declined, but the gap between collection and utilization is narrowing. As collections decline further and hospitals decrease transfusions and manage products more efficiently, the decline in surplus inventory may be a concern for disaster preparedness or other unexpected utilization needs.
| S-EPMC5928513 | biostudies-literature