Your browser doesn't support javascript.
Early safety indicators of COVID-19 convalescent plasma in 5000 patients.
Joyner, Michael J; Wright, R Scott; Fairweather, DeLisa; Senefeld, Jonathon W; Bruno, Katelyn A; Klassen, Stephen A; Carter, Rickey E; Klompas, Allan M; Wiggins, Chad C; Shepherd, John Ra; Rea, Robert F; Whelan, Emily R; Clayburn, Andrew J; Spiegel, Matthew R; Johnson, Patrick W; Lesser, Elizabeth R; Baker, Sarah E; Larson, Kathryn F; Ripoll, Juan G; Andersen, Kylie J; Hodge, David O; Kunze, Katie L; Buras, Matthew R; Vogt, Matthew Np; Herasevich, Vitaly; Dennis, Joshua J; Regimbal, Riley J; Bauer, Philippe R; Blair, Janis E; Van Buskirk, Camille M; Winters, Jeffrey L; Stubbs, James R; Paneth, Nigel S; Verdun, Nicole C; Marks, Peter; Casadevall, Arturo.
  • Joyner MJ; Department of Anesthesiology and Perioperative Medicine.
  • Wright RS; Department of Cardiovascular Medicine, and.
  • Fairweather D; Human Research Protection Program, Mayo Clinic, Rochester, Minnesota, USA.
  • Senefeld JW; Department of Cardiovascular Medicine and.
  • Bruno KA; Department of Anesthesiology and Perioperative Medicine.
  • Klassen SA; Department of Cardiovascular Medicine and.
  • Carter RE; Department of Anesthesiology and Perioperative Medicine.
  • Klompas AM; Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.
  • Wiggins CC; Department of Anesthesiology and Perioperative Medicine.
  • Shepherd JR; Department of Anesthesiology and Perioperative Medicine.
  • Rea RF; Department of Anesthesiology and Perioperative Medicine.
  • Whelan ER; Department of Cardiovascular Medicine, and.
  • Clayburn AJ; Department of Cardiovascular Medicine and.
  • Spiegel MR; Department of Anesthesiology and Perioperative Medicine.
  • Johnson PW; Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.
  • Lesser ER; Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.
  • Baker SE; Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.
  • Larson KF; Department of Anesthesiology and Perioperative Medicine.
  • Ripoll JG; Department of Cardiovascular Medicine, and.
  • Andersen KJ; Department of Anesthesiology and Perioperative Medicine.
  • Hodge DO; Department of Anesthesiology and Perioperative Medicine.
  • Kunze KL; Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.
  • Buras MR; Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, USA.
  • Vogt MN; Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, USA.
  • Herasevich V; Department of Anesthesiology and Perioperative Medicine.
  • Dennis JJ; Department of Anesthesiology and Perioperative Medicine.
  • Regimbal RJ; Department of Anesthesiology and Perioperative Medicine.
  • Bauer PR; Department of Anesthesiology and Perioperative Medicine.
  • Blair JE; Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, USA.
  • Van Buskirk CM; Department of Internal Medicine, Division of Infectious Diseases, Mayo Clinic, Phoenix, Arizona, USA.
  • Winters JL; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
  • Stubbs JR; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
  • Paneth NS; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
  • Verdun NC; Department of Epidemiology and Biostatistics and.
  • Marks P; Department of Pediatrics and Human Development, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.
  • Casadevall A; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
J Clin Invest ; 130(9): 4791-4797, 2020 09 01.
Article in English | MEDLINE | ID: covidwho-1365265
Semantic information from SemMedBD (by NLM)
1. Patients LOCATION_OF Plasma
Subject
Patients
Predicate
LOCATION_OF
Object
Plasma
2. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
3. human plasma TREATS Patient in hospital
Subject
human plasma
Predicate
TREATS
Object
Patient in hospital
4. Patient in hospital PROCESS_OF Adult
Subject
Patient in hospital
Predicate
PROCESS_OF
Object
Adult
5. Plasma ASSOCIATED_WITH Borg Category-Ratio 10 Perceived Exertion Score 5
Subject
Plasma
Predicate
ASSOCIATED_WITH
Object
Borg Category-Ratio 10 Perceived Exertion Score 5
6. human plasma TREATS Adult
Subject
human plasma
Predicate
TREATS
Object
Adult
7. Critical Illness PROCESS_OF Patients
Subject
Critical Illness
Predicate
PROCESS_OF
Object
Patients
8. hospitalized patients LOCATION_OF Plasma
Subject
hospitalized patients
Predicate
LOCATION_OF
Object
Plasma
9. Patients LOCATION_OF Plasma
Subject
Patients
Predicate
LOCATION_OF
Object
Plasma
10. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
11. human plasma TREATS Patient in hospital
Subject
human plasma
Predicate
TREATS
Object
Patient in hospital
12. Patient in hospital PROCESS_OF Adult
Subject
Patient in hospital
Predicate
PROCESS_OF
Object
Adult
13. Plasma ASSOCIATED_WITH Borg Category-Ratio 10 Perceived Exertion Score 5
Subject
Plasma
Predicate
ASSOCIATED_WITH
Object
Borg Category-Ratio 10 Perceived Exertion Score 5
14. human plasma TREATS Adult
Subject
human plasma
Predicate
TREATS
Object
Adult
15. Critical Illness PROCESS_OF Patients
Subject
Critical Illness
Predicate
PROCESS_OF
Object
Patients
16. hospitalized patients LOCATION_OF Plasma
Subject
hospitalized patients
Predicate
LOCATION_OF
Object
Plasma
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)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus Type of study: Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: North America Language: English Journal: J Clin Invest Year: 2020 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus Type of study: Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: North America Language: English Journal: J Clin Invest Year: 2020 Document Type: Article