Serveur d'exploration sur la COVID chez les séniors

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Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.

Identifieur interne : 000238 ( Main/Exploration ); précédent : 000237; suivant : 000239

Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.

Auteurs : Michael J. Joyner [États-Unis] ; Katelyn A. Bruno [États-Unis] ; Stephen A. Klassen [États-Unis] ; Katie L. Kunze [États-Unis] ; Patrick W. Johnson [États-Unis] ; Elizabeth R. Lesser [États-Unis] ; Chad C. Wiggins [États-Unis] ; Jonathon W. Senefeld [États-Unis] ; Allan M. Klompas [États-Unis] ; David O. Hodge [États-Unis] ; John R A. Shepherd [États-Unis] ; Robert F. Rea [États-Unis] ; Emily R. Whelan [États-Unis] ; Andrew J. Clayburn [États-Unis] ; Matthew R. Spiegel [États-Unis] ; Sarah E. Baker [États-Unis] ; Kathryn F. Larson [États-Unis] ; Juan G. Ripoll [États-Unis] ; Kylie J. Andersen [États-Unis] ; Matthew R. Buras [États-Unis] ; Matthew N P. Vogt [États-Unis] ; Vitaly Herasevich [États-Unis] ; Joshua J. Dennis [États-Unis] ; Riley J. Regimbal [États-Unis] ; Philippe R. Bauer [États-Unis] ; Janis E. Blair [États-Unis] ; Camille M. Van Buskirk [États-Unis] ; Jeffrey L. Winters [États-Unis] ; James R. Stubbs [États-Unis] ; Noud Van Helmond [États-Unis] ; Brian P. Butterfield [États-Unis] ; Matthew A. Sexton [États-Unis] ; Juan C. Diaz Soto [États-Unis] ; Nigel S. Paneth [États-Unis] ; Nicole C. Verdun [États-Unis] ; Peter Marks [États-Unis] ; Arturo Casadevall [États-Unis] ; Delisa Fairweather [États-Unis] ; Rickey E. Carter [États-Unis] ; R Scott Wright [États-Unis]

Source :

RBID : pubmed:32861333

Descripteurs français

English descriptors

Abstract

OBJECTIVE

To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients.

PATIENTS AND METHODS

From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma.

RESULTS

The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%).

CONCLUSION

These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.


DOI: 10.1016/j.mayocp.2020.06.028
PubMed: 32861333
PubMed Central: PMC7368917


Affiliations:


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<name sortKey="Verdun, Nicole C" sort="Verdun, Nicole C" uniqKey="Verdun N" first="Nicole C" last="Verdun">Nicole C. Verdun</name>
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<name sortKey="Casadevall, Arturo" sort="Casadevall, Arturo" uniqKey="Casadevall A" first="Arturo" last="Casadevall">Arturo Casadevall</name>
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<region type="state">Floride</region>
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<nlm:affiliation>Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN; Department of Human Research Protection Program, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
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<title xml:lang="en">Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.</title>
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<name sortKey="Joyner, Michael J" sort="Joyner, Michael J" uniqKey="Joyner M" first="Michael J" last="Joyner">Michael J. Joyner</name>
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<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN. Electronic address: https://twitter.com/DrMJoyner.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Bruno, Katelyn A" sort="Bruno, Katelyn A" uniqKey="Bruno K" first="Katelyn A" last="Bruno">Katelyn A. Bruno</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Klassen, Stephen A" sort="Klassen, Stephen A" uniqKey="Klassen S" first="Stephen A" last="Klassen">Stephen A. Klassen</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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</author>
<author>
<name sortKey="Kunze, Katie L" sort="Kunze, Katie L" uniqKey="Kunze K" first="Katie L" last="Kunze">Katie L. Kunze</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Arizona</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Scottsdale</wicri:cityArea>
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<author>
<name sortKey="Johnson, Patrick W" sort="Johnson, Patrick W" uniqKey="Johnson P" first="Patrick W" last="Johnson">Patrick W. Johnson</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Jacksonville</wicri:cityArea>
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<name sortKey="Lesser, Elizabeth R" sort="Lesser, Elizabeth R" uniqKey="Lesser E" first="Elizabeth R" last="Lesser">Elizabeth R. Lesser</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Jacksonville</wicri:cityArea>
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</author>
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<name sortKey="Wiggins, Chad C" sort="Wiggins, Chad C" uniqKey="Wiggins C" first="Chad C" last="Wiggins">Chad C. Wiggins</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
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<author>
<name sortKey="Senefeld, Jonathon W" sort="Senefeld, Jonathon W" uniqKey="Senefeld J" first="Jonathon W" last="Senefeld">Jonathon W. Senefeld</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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<name sortKey="Klompas, Allan M" sort="Klompas, Allan M" uniqKey="Klompas A" first="Allan M" last="Klompas">Allan M. Klompas</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
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<author>
<name sortKey="Hodge, David O" sort="Hodge, David O" uniqKey="Hodge D" first="David O" last="Hodge">David O. Hodge</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Jacksonville</wicri:cityArea>
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<author>
<name sortKey="Shepherd, John R A" sort="Shepherd, John R A" uniqKey="Shepherd J" first="John R A" last="Shepherd">John R A. Shepherd</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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<name sortKey="Rea, Robert F" sort="Rea, Robert F" uniqKey="Rea R" first="Robert F" last="Rea">Robert F. Rea</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Cardiovascular Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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<author>
<name sortKey="Whelan, Emily R" sort="Whelan, Emily R" uniqKey="Whelan E" first="Emily R" last="Whelan">Emily R. Whelan</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville</wicri:cityArea>
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<author>
<name sortKey="Clayburn, Andrew J" sort="Clayburn, Andrew J" uniqKey="Clayburn A" first="Andrew J" last="Clayburn">Andrew J. Clayburn</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Spiegel, Matthew R" sort="Spiegel, Matthew R" uniqKey="Spiegel M" first="Matthew R" last="Spiegel">Matthew R. Spiegel</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Jacksonville</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Baker, Sarah E" sort="Baker, Sarah E" uniqKey="Baker S" first="Sarah E" last="Baker">Sarah E. Baker</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Larson, Kathryn F" sort="Larson, Kathryn F" uniqKey="Larson K" first="Kathryn F" last="Larson">Kathryn F. Larson</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Ripoll, Juan G" sort="Ripoll, Juan G" uniqKey="Ripoll J" first="Juan G" last="Ripoll">Juan G. Ripoll</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
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<author>
<name sortKey="Andersen, Kylie J" sort="Andersen, Kylie J" uniqKey="Andersen K" first="Kylie J" last="Andersen">Kylie J. Andersen</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Buras, Matthew R" sort="Buras, Matthew R" uniqKey="Buras M" first="Matthew R" last="Buras">Matthew R. Buras</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Arizona</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Scottsdale</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Vogt, Matthew N P" sort="Vogt, Matthew N P" uniqKey="Vogt M" first="Matthew N P" last="Vogt">Matthew N P. Vogt</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Herasevich, Vitaly" sort="Herasevich, Vitaly" uniqKey="Herasevich V" first="Vitaly" last="Herasevich">Vitaly Herasevich</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Dennis, Joshua J" sort="Dennis, Joshua J" uniqKey="Dennis J" first="Joshua J" last="Dennis">Joshua J. Dennis</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Regimbal, Riley J" sort="Regimbal, Riley J" uniqKey="Regimbal R" first="Riley J" last="Regimbal">Riley J. Regimbal</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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<author>
<name sortKey="Bauer, Philippe R" sort="Bauer, Philippe R" uniqKey="Bauer P" first="Philippe R" last="Bauer">Philippe R. Bauer</name>
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<nlm:affiliation>Department of Internal Medicine, Division of Pulmonary and Critical Care, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Internal Medicine, Division of Pulmonary and Critical Care, Mayo Clinic, Rochester</wicri:cityArea>
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<author>
<name sortKey="Blair, Janis E" sort="Blair, Janis E" uniqKey="Blair J" first="Janis E" last="Blair">Janis E. Blair</name>
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<nlm:affiliation>Department of Internal Medicine, Division of Infectious Diseases, Mayo Clinic, Phoenix, AZ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Arizona</region>
</placeName>
<wicri:cityArea>Department of Internal Medicine, Division of Infectious Diseases, Mayo Clinic, Phoenix</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Van Buskirk, Camille M" sort="Van Buskirk, Camille M" uniqKey="Van Buskirk C" first="Camille M" last="Van Buskirk">Camille M. Van Buskirk</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Winters, Jeffrey L" sort="Winters, Jeffrey L" uniqKey="Winters J" first="Jeffrey L" last="Winters">Jeffrey L. Winters</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Stubbs, James R" sort="Stubbs, James R" uniqKey="Stubbs J" first="James R" last="Stubbs">James R. Stubbs</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester</wicri:cityArea>
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</author>
<author>
<name sortKey="Van Helmond, Noud" sort="Van Helmond, Noud" uniqKey="Van Helmond N" first="Noud" last="Van Helmond">Noud Van Helmond</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden, NJ.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden</wicri:cityArea>
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</author>
<author>
<name sortKey="Butterfield, Brian P" sort="Butterfield, Brian P" uniqKey="Butterfield B" first="Brian P" last="Butterfield">Brian P. Butterfield</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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</author>
<author>
<name sortKey="Sexton, Matthew A" sort="Sexton, Matthew A" uniqKey="Sexton M" first="Matthew A" last="Sexton">Matthew A. Sexton</name>
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<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester</wicri:cityArea>
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<author>
<name sortKey="Diaz Soto, Juan C" sort="Diaz Soto, Juan C" uniqKey="Diaz Soto J" first="Juan C" last="Diaz Soto">Juan C. Diaz Soto</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
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<name sortKey="Paneth, Nigel S" sort="Paneth, Nigel S" uniqKey="Paneth N" first="Nigel S" last="Paneth">Nigel S. Paneth</name>
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<nlm:affiliation>Departments of Epidemiology and Biostatistics and Pediatrics and Human Development, College of Human Medicine, Michigan State University, East Lansing.</nlm:affiliation>
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<country>États-Unis</country>
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<name sortKey="Verdun, Nicole C" sort="Verdun, Nicole C" uniqKey="Verdun N" first="Nicole C" last="Verdun">Nicole C. Verdun</name>
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<nlm:affiliation>Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Maryland</region>
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<name sortKey="Marks, Peter" sort="Marks, Peter" uniqKey="Marks P" first="Peter" last="Marks">Peter Marks</name>
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<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Maryland</region>
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<author>
<name sortKey="Casadevall, Arturo" sort="Casadevall, Arturo" uniqKey="Casadevall A" first="Arturo" last="Casadevall">Arturo Casadevall</name>
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<nlm:affiliation>Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Maryland</region>
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<wicri:cityArea>Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore</wicri:cityArea>
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<author>
<name sortKey="Fairweather, Delisa" sort="Fairweather, Delisa" uniqKey="Fairweather D" first="Delisa" last="Fairweather">Delisa Fairweather</name>
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<nlm:affiliation>Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville</wicri:cityArea>
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<name sortKey="Carter, Rickey E" sort="Carter, Rickey E" uniqKey="Carter R" first="Rickey E" last="Carter">Rickey E. Carter</name>
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<nlm:affiliation>Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Health Sciences Research, Mayo Clinic, Jacksonville</wicri:cityArea>
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<author>
<name sortKey="Wright, R Scott" sort="Wright, R Scott" uniqKey="Wright R" first="R Scott" last="Wright">R Scott Wright</name>
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<nlm:affiliation>Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN; Department of Human Research Protection Program, Mayo Clinic, Rochester, MN.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<region type="state">Minnesota</region>
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<wicri:cityArea>Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN; Department of Human Research Protection Program, Mayo Clinic, Rochester</wicri:cityArea>
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<title level="j">Mayo Clinic proceedings</title>
<idno type="eISSN">1942-5546</idno>
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<date when="2020" type="published">2020</date>
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<term>Adolescent (MeSH)</term>
<term>Adult (MeSH)</term>
<term>Adverse Drug Reaction Reporting Systems (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Aged, 80 and over (MeSH)</term>
<term>Coronavirus Infections (mortality)</term>
<term>Coronavirus Infections (therapy)</term>
<term>Critical Illness (MeSH)</term>
<term>Female (MeSH)</term>
<term>Hospitalization (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Immunization, Passive (adverse effects)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Patient Safety (MeSH)</term>
<term>Pneumonia, Viral (mortality)</term>
<term>Pneumonia, Viral (therapy)</term>
<term>United States (MeSH)</term>
<term>Young Adult (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adolescent (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Hospitalisation (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Immunisation passive (effets indésirables)</term>
<term>Infections à coronavirus (mortalité)</term>
<term>Infections à coronavirus (thérapie)</term>
<term>Jeune adulte (MeSH)</term>
<term>Maladie grave (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Pneumopathie virale (mortalité)</term>
<term>Pneumopathie virale (thérapie)</term>
<term>Sujet âgé (MeSH)</term>
<term>Sujet âgé de 80 ans ou plus (MeSH)</term>
<term>Systèmes de signalement des effets indésirables des médicaments (MeSH)</term>
<term>Sécurité des patients (MeSH)</term>
<term>États-Unis (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en">
<term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Immunization, Passive</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Immunisation passive</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="thérapie" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adolescent</term>
<term>Adult</term>
<term>Adverse Drug Reaction Reporting Systems</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Critical Illness</term>
<term>Female</term>
<term>Hospitalization</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Pandemics</term>
<term>Patient Safety</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Hospitalisation</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Maladie grave</term>
<term>Mâle</term>
<term>Pandémies</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Systèmes de signalement des effets indésirables des médicaments</term>
<term>Sécurité des patients</term>
<term>États-Unis</term>
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<keywords scheme="Wicri" type="geographic" xml:lang="fr">
<term>États-Unis</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVE</b>
</p>
<p>To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>PATIENTS AND METHODS</b>
</p>
<p>From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%).</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSION</b>
</p>
<p>These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.</p>
</div>
</front>
</TEI>
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<DateCompleted>
<Year>2020</Year>
<Month>09</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>09</Month>
<Day>12</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1942-5546</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>95</Volume>
<Issue>9</Issue>
<PubDate>
<Year>2020</Year>
<Month>09</Month>
</PubDate>
</JournalIssue>
<Title>Mayo Clinic proceedings</Title>
<ISOAbbreviation>Mayo Clin Proc</ISOAbbreviation>
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<ArticleTitle>Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.</ArticleTitle>
<Pagination>
<MedlinePgn>1888-1897</MedlinePgn>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.mayocp.2020.06.028</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVE">To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS">From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma.</AbstractText>
<AbstractText Label="RESULTS">The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%).</AbstractText>
<AbstractText Label="CONCLUSION">These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.</AbstractText>
<CopyrightInformation>Copyright © 2020. Published by Elsevier Inc.</CopyrightInformation>
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<ForeName>Katelyn A</ForeName>
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<Month>06</Month>
<Day>12</Day>
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<PubMedPubDate PubStatus="revised">
<Year>2020</Year>
<Month>06</Month>
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<ArticleId IdType="doi">10.1016/j.mayocp.2020.06.028</ArticleId>
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<li>Michigan</li>
<li>Minnesota</li>
<li>New Jersey</li>
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<name sortKey="Diaz Soto, Juan C" sort="Diaz Soto, Juan C" uniqKey="Diaz Soto J" first="Juan C" last="Diaz Soto">Juan C. Diaz Soto</name>
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<name sortKey="Ripoll, Juan G" sort="Ripoll, Juan G" uniqKey="Ripoll J" first="Juan G" last="Ripoll">Juan G. Ripoll</name>
<name sortKey="Senefeld, Jonathon W" sort="Senefeld, Jonathon W" uniqKey="Senefeld J" first="Jonathon W" last="Senefeld">Jonathon W. Senefeld</name>
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