New study validates benefits of convalescent plasma for some COVID-19
patients

Date:
January 25, 2022
Source:
NYU Langone Health / NYU Grossman School of Medicine
Summary:
Transfusions of blood plasma donated by people who have already
recovered from infection with the pandemic virus may help other
patients hospitalized with COVID-19, a new international study
shows.



FULL STORY ========================================================================== Transfusions of blood plasma donated by people who have already
recovered from infection with the pandemic virus may help other patients hospitalized with COVID-19, a new international study shows.


==========================================================================
The treatment, known as convalescent plasma, is still considered
experimental by the U.S. Food and Drug Administration (FDA). Plasma
contains antibodies, blood proteins that are part of the immune
system. Shaped so they can attach to the virus that causes COVID-19, SARS-CoV-2, antibodies glom onto and tag it for removal from the body, researchers say.

Led by researchers at NYU Grossman School of Medicine, the study
showed that among 2,341 men and women, those who received an injection
of convalescent plasma soon after hospitalization were 15% less likely
to die within a month from COVID-19 than those who did not receive
convalescent plasma or those who received an inactive saline placebo.

Notably, the researchers found that the biggest benefits for the therapy
were among patients most at risk for severe complications because of pre-existing conditions, such as diabetes or heart disease. The treatment, which contains antibodies and other immune cells needed to fight the
infection, also appears to benefit those with type A or AB blood.

"Our results show that, overall, patients hospitalized with COVID-19
may derive modest benefit from convalescent plasma, with some patient
subgroups benefiting more than others," says study lead investigator
and biostatistician Andrea Troxel, ScD. With respect to the groups most
likely to benefit, the FDA on Dec.

28, 2021, revised the Emergency Use Authorization for convalescent plasma, limiting its use to patients with diseases that suppress their immune
systems, or that receive medical treatments with the same effect.

"Patients with co-existing disease were most likely to show improvement
from convalescent plasma, probably because they have the most difficulty producing antibodies to fight their infection," adds Troxel. "The infused plasma boosts their body's ability to fight the virus, but only in the
early stage of the disease and before the illness overwhelms their body."
The current study findings, published in the journal JAMA Network Open
online Jan. 25, come from the pooling of patient information from eight recently completed studies in the United States, Belgium, Brazil, India,
the Netherlands, and Spain on the effects of convalescent plasma for
COVID-19.



========================================================================== These benefits of the treatment are only likely to become clear as more
data from the trials become available, says Troxel, a professor in the Department of Population Health at NYU Langone. This is because the data
from individual trials are too small to show the treatment's overall
impact on subsets of patients, she says. Some individual studies have
showed the therapy to be ineffective or of limited value.

Study co-investigator Eva Petkova, PhD, says the team is using its
study data to create a scoring system of patient descriptors, including
age, stage of COVID-19, and co-existing diseases, making it easier
for clinicians to calculate who stands to benefit most from use of
convalescent plasma.

"Our treatment benefit index is designed to serve as a quick and effective
tool for physicians to use in deciding when to administer convalescent
plasma for COVID-19," says Petkova, a professor in the Departments of Population Health and Child and Adolescent Psychiatry at NYU Langone.

For the study, researchers grouped all patient information from smaller, separate clinical investigations about convalescent plasma therapy,
including trials at NYU Langone, Albert Einstein College of Medicine and Montefiore Medical Center, Zuckerberg San Francisco General Hospital,
and the University of Pennsylvania in Philadelphia. Researchers hoped
any benefits or disadvantages in treatment would be easier to spot among
the largest possible sample of patients. All trials were randomized
and controlled, meaning that the patient had a random chance of being
assigned to receive convalescent plasma or not to receive it.

Included in the analysis were data from another multicenter U.S. study published separately in December 2021 in JAMA Internal Medicine. That
study in 941 patients hospitalized with COVID-19 showed that patients
receiving high doses of convalescent plasma therapy and not on other medications, such as remdesivir or corticosteroids, were likely to
benefit from the blood plasma treatment. Study co-primary investigator
Mila Ortigoza, MD, PhD, an assistant professor in the Departments of
Medicine and Microbiology at NYU Langone, says these initial results
supported the idea that convalescent plasma could be a feasible treatment option, especially when other therapies are not yet available, as at
the beginning of a pandemic.

In addition, convalescent plasma collected from previously infected and subsequently vaccinated donors (VaxPlasma) would contain antibodies in
high enough quantities and diversity that could provide added protection against emerging viral variants, says Ortigoza. Viruses typically
mutate genetically (acquire random changes in their DNA or RNA codes)
over the course of any pandemic. For this reason, convalescent plasma
has the potential to offer effective treatment more quickly after such mutations than treatment types that tend to become less effective with
time and must undergo a re-design process to address a new variant,
such as monoclonal antibody treatments.

Besides Troxel, Petkova, and Ortigoza, other NYU Langone researchers
involved in the studies are Keith Goldfeld, DrPh; Mengling Liu, PhD; Hyung Park, PhD; Thaddeus Tarpey, PhD; Yinxiang Wu, MA; Danni Wu, MS; Yi Li,
MS; Corita Grudzen, MD; and Judith Hochman, MD. Other study investigators include Anup Agarwal, MD; Gunjan Kumar, MD; and Aparna Mukherjee, MD,
PhD; at the Indian Council of Medical Research in New Delhi; Cristina Avendan~o-Sola, MD; Rafael Duarte, MD, PhD, and Arantxa Sancho-Lopez,
MD; at the Hospital Universitario Puerta de Hierro Majadahonda in
Madrid, Spain; Emma Bainbridge, MD, MPH; Priscilla Hsue, MD; and Annie Luetkemeyer, MD; at the University of California San Francisco; Katherine
Bar, MD; and Pamela Shaw, PhD; at the University of Pennsylvania in Philadelphia (now at Kaiser Permanente); Timothy Devos, MD, PhD; and Geert Meyfroidt, MD, PhD; at Katholieke Universiteit in Leuven, Belgium; Andre' Nicola, MD, PhD; at the University of Brasilia in Brazil; Liise-Anne
Pirofski, MD, PhD; and Hyun-Ah Yoon, MD; at Albert Einstein College of
Medicine in New York City; Bart Rijnders, MD, PhD; and Casper Rokx, MD,
PhD; at Erasmus University in the Netherlands; and Elliott Antman, MD,
at Harvard University in Boston. Funding support for the studies was
provided by National Institutes of Health grant UL1TR001445.

========================================================================== Story Source: Materials provided by NYU_Langone_Health_/_NYU_Grossman_School_of_Medicine.

Note: Content may be edited for style and length.


========================================================================== Journal References:
1. Hyung Park, Thaddeus Tarpey, Mengling Liu, Keith Goldfeld,
Yinxiang Wu,
Danni Wu, Yi Li, Jinchun Zhang, Dipyaman Ganguly, Yogiraj Ray,
Shekhar Ranjan Paul, Prasun Bhattacharya, Artur Belov, Yin Huang,
Carlos Villa, Richard Forshee, Nicole C. Verdun, Hyun ah Yoon,
Anup Agarwal, Ventura Alejandro Simonovich, Paula Scibona, Leandro
Burgos Pratx, Waldo Belloso, Cristina Avendan~o-Sola', Katharine
J Bar, Rafael F. Duarte, Priscilla Y.

Hsue, Anne F. Luetkemeyer, Geert Meyfroidt, Andre' M. Nicola,
Aparna Mukherjee, Mila B. Ortigoza, Liise-anne Pirofski,
Bart J. A. Rijnders, Andrea Troxel, Elliott M. Antman, Eva
Petkova. Development and Validation of a Treatment Benefit Index to
Identify Hospitalized Patients With COVID-19 Who May Benefit From
Convalescent Plasma. JAMA Network Open, 2022; 5 (1): e2147375 DOI:
10.1001/jamanetworkopen.2021.47375
2. Mila B. Ortigoza, Hyunah Yoon, Keith S. Goldfeld, Andrea B. Troxel,
Johanna P. Daily, Yinxiang Wu, Yi Li, Danni Wu, Gia F. Cobb, Gillian
Baptiste, Mary O'Keeffe, Marilou O. Corpuz, Luis Ostrosky-Zeichner,
Amee Amin, Ioannis M. Zacharioudakis, Dushyantha T. Jayaweera,
Yanyun Wu, Julie V. Philley, Megan S. Devine, Mahalia
S. Desruisseaux, Alessandro D.

Santin, Shweta Anjan, Reeba Mathew, Bela Patel, Masayuki Nigo,
Rabi Upadhyay, Tania Kupferman, Andrew N. Dentino, Rahul Nanchal,
Christian A.

Merlo, David N. Hager, Kartik Chandran, Jonathan R. Lai, Johanna
Rivera, Chowdhury R. Bikash, Gorka Lasso, Timothy P. Hilbert,
Monika Paroder, Andrea A. Asencio, Mengling Liu, Eva Petkova,
Alexander Bragat, Reza Shaker, David D. McPherson, Ralph L. Sacco,
Marla J. Keller, Corita R.

Grudzen, Judith S. Hochman, Liise-anne Pirofski, and the
CONTAIN COVID-19 Consortium for the CONTAIN COVID-19 Study
Group. Efficacy and Safety of COVID-19 Convalescent Plasma
in Hospitalized Patients. JAMA Internal Medicine, 2021; DOI:
10.1001/jamainternmed.2021.6850 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/01/220125112553.htm

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