Rapid development of a de novo convalescent plasma program in response to a global pandemic: A large southeastern U.S. blood center's experience.
J Clin Apher
; 36(4): 533-546, 2021 Aug.
Article
Dans Anglais
| MEDLINE | ID: covidwho-1107655
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
ABSTRACT
BACKGROUND:
During the pandemic in the spring of 2020 with no vaccine or treatment for SARS-CoV-2 and its associated disease, COVID-19, convalescent plasma from recovered COVID-19 (CCP) patients offered a potential therapy. In March 2020, the United States (U.S.) Food and Drug Administration (FDA) authorized CCP under emergency Investigational New Drug (eIND) exemption and an IRB-approved Expanded Access Program (EAP) to treat severe COVID-19. Hospital demand grew rapidly in the Southeastern U.S., resulting in backlogs of CCP orders. We describe a large U.S. blood center's (BC) rapid implementation of a CCP program in response to community needs. STUDY DESIGN ANDMETHODS:
From April 2 to May 17, 2020, CCP was collected by whole blood or apheresis. Initial manual approaches to donor intake, collection, and distribution were rapidly replaced with automated processes. All CCP donors and products underwent FDA-required screening and testing.RESULTS:
A total of 619 CCP donors (299 females, 320 males) presented for CCP donation (161 [25.7%] whole blood, 466 [74.3%] plasmapheresis) resulting in 1219 CCP units. Production of CCP increased as processes were automated and streamlined, from a mean of 11 donors collected/day for the first month to a mean of 25 donors collected/day in the subsequent 2 weeks. Backlogged orders were cleared, and inventory began to accumulate 4 weeks after project initiation.CONCLUSION:
The BC was able to implement an effective de novo CCP collection program within 6 weeks in response to a community need in a global pandemic. Documentation of the experience may inform preparedness for future pandemics.Mots clés
Texte intégral:
Disponible
Collection:
Bases de données internationales
Base de données:
MEDLINE
Sujet Principal:
SARS-CoV-2
/
COVID-19
Les sujets:
Vaccins
Limites du sujet:
Adulte
/
Femelle
/
Humains
/
Mâle
/
Adulte d'âge moyen
langue:
Anglais
Revue:
J Clin Apher
Année:
2021
Type de document:
Article
Pays d'affiliation:
Jca.21889
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