Clinical trial indicates monoclonal antibody lowered hospitalizations
and emergency visits
Therapy may hold promise for fighting pandemic

Date:
October 30, 2020
Source:
Cedars-Sinai Medical Center
Summary:
COVID-19 (coronavirus) patients who were administered a novel
antibody had fewer symptoms and were less likely to require
hospitalization or emergency medical care than those who did not
receive the antibody, according to a new study.



FULL STORY ========================================================================== COVID-19 (coronavirus) patients who were administered a novel antibody
had fewer symptoms and were less likely to require hospitalization or
emergency medical care than those who did not receive the antibody,
according to a new study published in the The New England Journal of
Medicine.


==========================================================================
The multisite, Phase II clinical trial tested three different doses of
LY- CoV555, a monoclonal antibody derived from the blood of a recovered COVID-19 patient. While the trial is ongoing, results from the interim
analysis indicated a reduced viral load in outpatients with mild to
moderate cases of COVID-19 at the 2,800-milligram dosage level, along
with reduced rates of hospitalization and emergency medical care among
patients at all dosage levels.

The study's co-first author, Peter Chen, MD, professor of Medicine and
director of the Division of Pulmonary and Critical Care Medicine at Cedars-Sinai, said the results are promising.

"For me, the most significant finding was the reduction in
hospitalizations," Chen said. "Monoclonal antibodies like this have the potential to reduce the severity of COVID-19 for many patients, allowing
more people to recover at home." Monoclonal antibodies work by attaching themselves to a virus and preventing it from replicating. LY-CoV555
binds to a particular protein, called a spike protein, which SARS-CoV-2,
the virus that causes COVID-19, needs in order to enter human cells and replicate. By preventing the virus from replicating, the antibody slows
down the viral process, allowing the patient's own immune system time
to kick into gear.

"What we're doing is preventing the virus from causing too much damage
early on in the process," Chen said. "We're buying the patients time,
so that their bodies can start developing their own immunity to fight
the virus." Patients in the randomized, double-blind study were given intravenous doses of either 700, 2,800 or 7,000 milligrams of the
antibody, or a placebo.

Investigators used a nasopharyngeal swab to test patients' viral
load before administering the antibody and again at several points
after administering the drug. Patients in the trial were also given a questionnaire about their subsequent symptoms and treatment.



========================================================================== Approximately 300 patients received the treatment (100 patients per dosage level) and approximately 150 patients received the placebo. Of the three
dosage levels, the 2,800-milligram dosage was shown to be effective in
reducing viral load. By day 11, viral load was substantially diminished
for most patients, including those in the placebo arm. Further studies
will be needed to validate these results, according to the investigators.

"The publication of these data in a peer-reviewed journal adds to the
growing body of evidence for the potential utility for neutralizing
antibodies as therapeutics for people recently diagnosed with mild to
moderate COVID-19, particularly high-risk patients," said Ajay Nirula, MD,
PhD, vice president of immunology at Eli Lilly and Company and co-first
author of the study. "These data show LY-CoV555 may be effective in
treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients." At day 29, hospitalization rates were
only 1.6% in the antibody-treated group, compared with 6.3% in the group
that received the placebo.

Importantly, the reduction in hospitalizations was seen across all
demographic groups, including those in high-risk categories: adults older
than 65 and those with a high body mass index (greater than 35). For
high-risk patients, hospitalization rates were 4.2% in patients treated
with the antibody, compared with 14.6% in placebo-treated patients. The
safety profile of patients treated with LY-CoV555 was similar to that
of placebo-treated patients.

"We know that COVID-19 is especially hard on the elderly, the obese and
people with certain pre-existing health conditions," Chen said. "Antibody treatments like this may have the most benefits for people in these
higher-risk categories." The corresponding author of the new study
was Daniel M. Skovronsky, MD, PhD, from Eli Lilly and Company. The
other co-first author was Ajay Nirula, MD, PhD, also from Eli Lilly
and Company. The research involved investigators from a total of 11 institutions and companies.

Funding: This trial was funded by Eli Lilly and Company.


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


========================================================================== Journal Reference:
1. Peter Chen, Ajay Nirula, Barry Heller, Robert L. Gottlieb,
Joseph Boscia,
Jason Morris, Gregory Huhn, Jose Cardona, Bharat Mocherla, Valentina
Stosor, Imad Shawa, Andrew C. Adams, Jacob Van Naarden, Kenneth L.

Custer, Lei Shen, Michael Durante, Gerard Oakley, Andrew
E. Schade, Janelle Sabo, Dipak R. Patel, Paul Klekotka, Daniel
M. Skovronsky. SARS- CoV-2 Neutralizing Antibody LY-CoV555 in
Outpatients with Covid-19. New England Journal of Medicine, 2020;
DOI: 10.1056/NEJMoa2029849 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/10/201030111837.htm

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