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1.
PLoS Med ; 18(12): e1003872, 2021 12.
Article in English | MEDLINE | ID: covidwho-1581903

ABSTRACT

BACKGROUND: The 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 FINDINGS: Mayo 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. CONCLUSIONS: These 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 REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360.


Subject(s)
COVID-19/therapy , Compassionate Use Trials/methods , Health Services Needs and Demand/statistics & numerical data , Hospital Distribution Systems/organization & administration , Registries , Transfusion Reaction/complications , Transfusion Reaction/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Ethnic and Racial Minorities , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Inpatients , Male , Medically Underserved Area , Middle Aged , Pandemics , Patient Safety , SARS-CoV-2 , Treatment Outcome , United States
2.
J Clin Invest ; 130(9): 4791-4797, 2020 09 01.
Article in English | MEDLINE | ID: covidwho-1365265

ABSTRACT

BACKGROUNDConvalescent plasma is the only antibody-based therapy currently available for patients with coronavirus disease 2019 (COVID-19). It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19.METHODSThus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent plasma.RESULTSThe incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first 4 hours after transfusion was <1%. Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n = 4), transfusion-associated circulatory overload (n = 7), transfusion-related acute lung injury (n = 11), and severe allergic transfusion reactions (n = 3). However, only 2 of 36 SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The 7-day mortality rate was 14.9%.CONCLUSIONGiven the deadly nature of COVID-19 and the large population of critically ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.TRIAL REGISTRATIONClinicalTrials.gov NCT04338360.FUNDINGMayo Clinic, Biomedical Advanced Research and Development Authority (75A50120C00096), National Center for Advancing Translational Sciences (UL1TR002377), National Heart, Lung, and Blood Institute (5R35HL139854 and R01 HL059842), National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK07352), Natural Sciences and Engineering Research Council of Canada (PDF-532926-2019), National Institute of Allergy and Infectious Disease (R21 AI145356, R21 AI152318, and AI152078), Schwab Charitable Fund, United Health Group, National Basketball Association, Millennium Pharmaceuticals, and Octapharma USA Inc.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19 , Compassionate Use Trials , Coronavirus Infections/epidemiology , Coronavirus Infections/mortality , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/mortality , Male , Middle Aged , Pandemics , Pneumonia, Viral/epidemiology , SARS-CoV-2 , Safety , Transfusion Reaction/epidemiology , Transfusion Reaction/etiology , Transfusion-Related Acute Lung Injury/epidemiology , Transfusion-Related Acute Lung Injury/etiology , United States/epidemiology , United States Food and Drug Administration , Young Adult
3.
Transfusion ; 61(5): 1389-1393, 2021 05.
Article in English | MEDLINE | ID: covidwho-1069423

ABSTRACT

BACKGROUND: COVID-19 safety measures and possibly SARS-CoV-2 antibody testing may alter blood donor demography, which has the potential to alter blood safety. We characterized pre-pandemic and pandemic rates of donor infectious disease marker (IDM) reactivity which reflect the residual risk of transfusion-transmitted infections (TTIs) undetectable by current testing. METHODS: This cross-sectional analysis of allogeneic blood donor presentations and successful donations in a large national US blood collector identifies changes in self-reported behavioral risk factors and IDM reactivity. Data on allogeneic blood donor presentations and successful donations from March 1 through August 31, 2020 and the same period in 2019 were retrieved from the blood center's computer system. Donor demographics and deferrals for reported behavioral risk factors and confirmed-positive IDMs were compared in pre-pandemic and pandemic periods. RESULTS: With increasing mobile blood drive cancellations, pandemic donors were more likely than 2019 donors to be female, over age 30, non-Hispanic Whites, and have a post-secondary degree. First-time donations (at highest risk for confirmed-positive IDMs) did not substantially increase. Pandemic donors reported fewer behavioral risks and IDMs declined among these donors. Mid-pandemic introduction of screening for SARS-CoV-2 antibodies did not affect IDM rates. CONCLUSIONS: Unlike disasters, which tend to bring out more first-time donors with increased IDM reactivity and TTI residual risk, COVID-19 donors had lower IDM rates which were not affected by SARS-CoV-2 antibody testing. Already-low TTI residual risk is likely to have declined as a result.


Subject(s)
Blood Donors , Blood Safety , COVID-19 , SARS-CoV-2/metabolism , Transfusion Reaction , Adolescent , Adult , Aged , COVID-19/blood , COVID-19/epidemiology , COVID-19/ethnology , COVID-19/transmission , Female , Humans , Male , Middle Aged , Pandemics , Risk Factors , Transfusion Reaction/epidemiology , Transfusion Reaction/ethnology , Transfusion Reaction/prevention & control
4.
Transfusion ; 60(12): 3046-3054, 2020 12.
Article in English | MEDLINE | ID: covidwho-717337

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel human coronavirus responsible for coronavirus disease 2019 (COVID-19). The emergence of this virus in Wuhan, China, at the end of 2019 and its worldwide spread to reach the pandemic stage has raised concerns about the possible risk that it might be transmissible by transfusion. This theoretical risk is further supported by reports of the detection of viral RNA in the blood of some infected individuals. To further address this risk, a thorough PubMed literature search was performed to systematically identify studies reporting data on the detection of SARS-CoV-2 RNA in blood or its components. Complementary searches were done to identify articles reporting data on the in vitro infectivity of blood components. At least 23 articles presenting data on the detection of SARS-CoV-2 RNA in blood, plasma, or serum were identified. Of these, three studies reported on blood donors with COVID-19 infection identified after donation, and no cases of transfusion transmission were identified. A few studies mentioned results of in vitro infectivity assays of blood components in permissive cell lines, none of which were able to detect infectious virus in blood or its components. Complementary searches have identified reports demonstrating that the correlation between the presence of viral RNA in a biologic sample and infectivity requires a minimal RNA load, which is rarely, if ever, observed in blood components. Overall, the available evidence suggests that the risk of transmission of SARS-CoV-2 by transfusion remains theoretical.


Subject(s)
Blood Donors , Blood Transfusion , COVID-19/transmission , Pandemics , RNA, Viral/blood , SARS-CoV-2/isolation & purification , Transfusion Reaction/epidemiology , Viremia/transmission , CD4-Positive T-Lymphocytes/virology , COVID-19/blood , COVID-19/epidemiology , Cell Line , Endothelial Cells/virology , Humans , SARS-CoV-2/physiology , Viral Load , Viremia/blood , Viremia/epidemiology , Virus Cultivation
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