Convalescent plasma can be effective early COVID-19 therapy, study finds


Date:
March 31, 2022
Source:
Johns Hopkins Medicine
Summary:
Research shows that high-titer (antibody-rich) COVID convalescent
plasma -- when administered to COVID-19 outpatients within nine days
after testing positive -- reduced the need for hospitalization for
more than half of a study's predominantly unvaccinated outpatients.



FULL STORY ==========================================================================
The New England Journal of Medicine(NEJM) today published final results
of a nationwide multicenter study led by researchers at Johns Hopkins
Medicine and the Johns Hopkins Bloomberg School of Public Health that
show plasma from patients who have recovered from COVID-19 and whose
blood contains antibodies against SARS-CoV-2, the causative virus,
is an effective and safe option as an early outpatient treatment for
the disease.


==========================================================================
The research showed that high-titer (antibody-rich) COVID convalescent
plasma - - when administered to COVID-19 outpatients within nine days
after testing positive -- reduced the need for hospitalization for more
than half of the study's predominantly unvaccinated outpatients. The
U.S. Food and Drug Administration (FDA) currently authorizes this plasma
as a treatment option for outpatients with immunocompromising diseases
or receiving immunocompromising medications, and for all patients
hospitalized with early-stage COVID-19.

The findings were first presented in a preprint posted
to MedRxiv on Dec. 21, 2021. Details of the study,
including authors and funding sources, may be found in
the Johns Hopkins news release issued at that time (https:// www.hopkinsmedicine.org/news/newsroom/news-releases/early-use-of-convalescent- plasma-may-help-outpatients-with-covid-19-avoid-hospitalization).

"Based on our findings and conclusions -- which are now validated through
the peer-review process -- we encourage health care professionals to
keep SARS-CoV- 2 antibody-rich blood plasma available in their blood
banks as part of the treatment arsenal against early-stage COVID-19,"
says study co-lead author David Sullivan, M.D., professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of
Public Health with a joint appointment in infectious diseases at the
Johns Hopkins University School of Medicine.

"We believe that the best role for convalescent plasma is extending its
use to early outpatient treatment when other therapies, such as monoclonal antibodies or drugs, are either not readily available -- as in low- and middle-income countries -- or ineffective, as with SARS-CoV-2 variants
that are resistant to certain monoclonal antibodies," Sullivan adds.

In the outpatient early-treatment study conducted between June 2020
and October 2021, the researchers provided 1,181 randomized patients
with one dose each of either polyclonal high-titer convalescent plasma (containing a concentrated mixture of antibodies specific to SARS-CoV-2)
or placebo control plasma (with no SARS-CoV-2 antibodies). The patients
were 18 and older, and had tested positive for SARS-CoV-2 within eight
days prior to transfusion. A successful therapy was defined as a patient
not requiring hospitalization within 28 days after plasma transfusion.



==========================================================================
The study found that 17 patients out of 592 (2.9%) who received the convalescent plasma required hospitalization within 28 days of their transfusion, compared with 37 out of 589 (6.3%) who received placebo
control plasma. This translated to a relative risk reduction for hospitalization of 54%.

Timing of the convalescent plasma transfusion also is critical: "The
earlier the better," the researchers say.

"Based on the findings of an analysis in the new paper that wasn't
available when the preprint was posted, we found that if convalescent
plasma is given within five days after diagnosis, the effectiveness at
reducing hospitalization approximated 80%," says Sullivan.

"We concluded that these results strongly support high-titer SARS-CoV-
2 convalescent plasma as an effective early treatment for COVID-19 with advantages such as low cost, wide availability and rapid resilience to
the virus's evolving variants," says study co-lead author Kelly Gebo,
M.D., M.P.H., professor of medicine at the Johns Hopkins University
School of Medicine.

The next step, the researchers say, is to make convalescent plasma for
the outpatient treatment of COVID-19 easier to use, more efficiently administered and more accessible to those who might need it. As part of
that effort, they have provided clinicians with a guide for implementing
a plasma transfusion center for outpatients with COVID-19, including logistical, staffing and blood banking requirements. The guide appears
in a paper published March 29, 2022, in the journal Transfusion.

The team also continues to seek more understanding of what else
convalescent plasma can do for outpatients with COVID-19. A soon-to-be published study will look at the ability of plasma to neutralize
SARS-CoV-2 variants, including delta and omicron, despite no previous
donor exposure to those viruses.

Since the study findings were first announced last December, there have
been three developments supporting the use of convalescent plasma for early-stage COVID-19:
* On Dec. 28, 2021, the FDA expanded the authorized emergency use of
convalescent plasma with high titers of anti-SARS-CoV-2 antibodies
"for the treatment of COVID-19 in patients with immunosuppressive
disease or receiving immunosuppressive treatment, in either the
outpatient or inpatient setting."
* On Feb. 2, 2022, the Infectious Disease Society of America
updated its
"Guidelines on the Treatment and Management of Patients
with COVID-19" to include the "use of convalescent plasma in
ambulatory patients with mild- to-moderate COVID-19 at high risk
for progression to severe disease with no other treatment options."
* On March 7, 2022, the American Red Cross announced that it was
"temporarily testing all blood donations for COVID-19 antibodies to
help identify donations that could be processed into convalescent
plasma." The organization said this was being done "to help support
immunocompromised patients battling COVID-19."
"These recent acknowledgements of high-titer convalescent plasma's
benefit in treating early-stage COVID-19 -- in conjunction with our peer-reviewed findings and our new guide for more effective administration
of the treatment -- provide clinicians with an additional option for outpatients," Gebo says.


========================================================================== Story Source: Materials provided by Johns_Hopkins_Medicine. Note:
Content may be edited for style and length.


========================================================================== Journal Reference:
1. David J. Sullivan, Kelly A. Gebo, Shmuel Shoham, Evan M. Bloch,
Bryan
Lau, Aarthi G. Shenoy, Giselle S. Mosnaim, Thomas J. Gniadek,
Yuriko Fukuta, Bela Patel, Sonya L. Heath, Adam C. Levine, Barry
R. Meisenberg, Emily S. Spivak, Shweta Anjan, Moises A. Huaman,
Janis E. Blair, Judith S. Currier, James H. Paxton, Jonathan
M. Gerber, Joann R. Petrini, Patrick B. Broderick, William Rausch,
Marie-Elena Cordisco, Jean Hammel, Benjamin Greenblatt, Valerie
C. Cluzet, Daniel Cruser, Kevin Oei, Matthew Abinante, Laura
L. Hammitt, Catherine G. Sutcliffe, Donald N. Forthal, Martin
S. Zand, Edward R. Cachay, Jay S. Raval, Seble G. Kassaye, E.

Colin Foster, Michael Roth, Christi E. Marshall, Anusha Yarava,
Karen Lane, Nichol A. McBee, Amy L. Gawad, Nicky Karlen, Atika
Singh, Daniel E.

Ford, Douglas A. Jabs, Lawrence J. Appel, David M. Shade, Stephan
Ehrhardt, Sheriza N. Baksh, Oliver Laeyendecker, Andrew Pekosz,
Sabra L.

Klein, Arturo Casadevall, Aaron A.R. Tobian, Daniel F. Hanley. Early
Outpatient Treatment for Covid-19 with Convalescent Plasma. New
England Journal of Medicine, 2022; DOI: 10.1056/NEJMoa2119657 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/03/220331101617.htm

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