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\begin{document}

\title{Real Life Experience with Monoclonal antibody -Sotrovimab in High Risk
COVID-19 Patients: A Retrospective Study in a Lebanese Tertiary Care
University Hospital.}



\author[1]{Sarah Nahhal}%
\author[1]{Celia  El-Halabi }%
\author[1]{Nisrine  Haddad }%
\author[1]{Rony Zeenny }%
\author[1]{Ghattas  Khoury }%
\author[1]{Abdul Rahman  Bizri }%
\author[1]{Souha Kanj}%
\author[1]{Nesrine Rizk}%
\affil[1]{American University of Beirut}%


\vspace{-1em}



  
  \date{May 15, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Abstract: Background: Sotrovimab, a monoclonal antibody, is among the
approved therapies for coronavirus disease -- 2019 (COVID-19).
Sotrovimab binds to the spike protein of the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) and inhibits virus attachment to
human cells. Real-life experience about the effectiveness of Sotrovimab
is limited. We aimed to evaluate the efficacy of Sotrovimab in
preventing COVID-19 hospitalizations and other patient-related outcomes
as well as the appropriateness of use in an academic hospital in
Lebanon. Methodology: In this retrospective observational study, we
included adult patients with positive test results for SARS-CoV-2 who
received intravenous (IV) Sotrovimab at the American University of
Beirut Medical Center (AUBMC) from November 2021 through March 2022. The
data collected included patient demographics and comorbidities. Primary
outcomes were hospitalization, deterioration after 24 hours, and death
due to any cause up to 60 days after the Sotrovimab infusion. Secondary
outcomes were progression to critical illness and adverse events.
Results: A total of 62 subjects received Sotrovimab infusion at our
hospital. More than 50\% of the patients had a malignancy. About 77\% of
the cohort belonged to Tier 1 of the National Institutes of Health (NIH)
criteria for Sotrovimab use, and 21\% of the patients had clinical
deterioration 24 hours after Sotrovimab infusion. The percentage of
progression to critical disease was 9.7\% and the mortality 6.5 \%.
Conclusion: Sotrovimab is effective against COVID-19 infection and
prevents mortality in high-risk patients.%
\end{abstract}%



\sloppy


\textbf{Real Life Experience with Monoclonal antibody -Sotrovimab in
High Risk COVID-19 Patients: A Retrospective Study in a Lebanese
Tertiary Care University Hospital.}

\textbf{Sarah B. Nahhal\textsuperscript{1*}, Celia
El-Halabi\textsuperscript{2*}, Nisrine Haddad\textsuperscript{2},
Rony~M. Zeenny\textsuperscript{2}, Ghattas Khoury\textsuperscript{3},
Abdul Rahman Bizri\textsuperscript{1}, Souha S.
kanj\textsuperscript{1,}Nesrine Rizk\textsuperscript{1}.}

\textsuperscript{\textbf{1:}} Division of Infectious Diseases,
Department of Internal Medicine, American University of Beirut Medical
Center, Beirut, Lebanon

\textsuperscript{\textbf{2:}} Pharmacy Department, American University
of Beirut Medical Center, Beirut, Lebanon.

\textsuperscript{\textbf{3}}\textbf{:} Department of General Surgery,
American University of Beirut Medical Center, Beirut, Lebanon

*: Both Authors contributed equally

\textbf{Corresponding Author:}

Dr. Nesrine Rizk, MD, FIDSA

Clinical Assistant Professor- Division of Infectious Diseases

Director, Antimicrobial Stewardship program

Director, ID fellowship Training Program

American University of Beirut

Beirut- Lebanon

nr00@aub.edu.lb



\textbf{Abstract:}

\textbf{Background:} Sotrovimab, a monoclonal antibody, is among the
approved therapies for coronavirus disease -- 2019 (COVID-19).
Sotrovimab binds to the spike protein of the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) and inhibits virus attachment to
human cells. Real-life experience about the effectiveness of Sotrovimab
is limited. We aimed to evaluate the efficacy of Sotrovimab in
preventing COVID-19 hospitalizations and other patient-related outcomes
as well as the appropriateness of use in an academic hospital in
Lebanon.

\textbf{Methodology:} In this retrospective observational study, we
included adult patients with positive test results for SARS-CoV-2 who
received intravenous (IV) Sotrovimab at the American University of
Beirut Medical Center (AUBMC) from November 2021 through March 2022. The
data collected included patient demographics and comorbidities. Primary
outcomes were hospitalization, deterioration after 24 hours, and death
due to any cause up to 60 days after the Sotrovimab infusion. Secondary
outcomes were progression to critical illness and adverse events.

\textbf{Results:} A total of 62 subjects received Sotrovimab infusion at
our hospital. More than 50\% of the patients had a malignancy. About
77\% of the cohort belonged to Tier 1 of the National Institutes of
Health (NIH) criteria for Sotrovimab use, and 21\% of the patients had
clinical deterioration 24 hours after Sotrovimab infusion. The
percentage of progression to critical disease was 9.7\% and the
mortality 6.5 \%.

\textbf{Conclusion:} Sotrovimab is effective against COVID-19 infection
and prevents mortality in high-risk patients.

\textbf{Keywords: COVID-19, Sotrovimab, Monoclonal antibodies, Lebanon,
Middle East, low- and middle-income countries, high risk}

\textbf{Running Title:} Sotrovimab Early Use in COVID-19

\textbf{Introduction:}

The COVID-19 pandemic continues to pose a significant burden on
healthcare systems around the world with successive waves and an
increasing death toll despite progress in antiviral therapy and vaccine
development{[}1{]} . More than 6 million COVID-19-related deaths have
been reported globally as of July 2022 {[}2{]}. In Lebanon, more than 1
million confirmed COVID-19 cases along with more than 10,000 deaths have
been reported so far {[}2-3{]}.

Several factors are associated with an increased risk of COVID-19
progression to severe disease. Older age is a strong risk factor for
poor outcomes{[}3-4{]}. The number of deaths, due to COVID-19 in the
United States (U.S) in patients who are older than 65 years, was around
125 times higher than those aged between 18 and 29 years {[}4-5{]}.
Similarly, in Lebanon, the reported number of deaths due to COVID-19 in
patients older than 60 years was around 100 times higher than those aged
between 20 and 29 years {[}6{]}. Other conditions associated with
hospital admission, progression to critical illness, and mortality
include cerebrovascular disease, chronic kidney disease (CKD), chronic
lung disease, chronic liver disease, diabetes mellitus, cardiovascular
conditions, autoimmune diseases, immunocompromising conditions, mental
health disorders, obesity, and male gender {[}7{]}. Vaccination and herd
immunity have contributed to decreasing the mortality associated with
COVID-19 despite wide variations related to pre-existing co-morbidities
and other risk factors {[}8{]} .

Monoclonal antibodies for COVID-19 are recommended either as
post-exposure prophylaxis (PEP) for ambulatory patients with mild to
moderate COVID-19 or pre-exposure prophylaxis for those who are at high
risk for progression to severe disease {[}9{]}. They bind to virus spike
protein and prevent the virus attachment to human cells , and mark the
virus for elemination {[}10{]}. Sotrovimab is a recombinant human
immunoglobulin G-1 (IgG1-Kappa) monoclonal antibody that binds to a
conserved epitope on the spike protein receptor binding domain of
SARS-CoV-2 and inhibits an undefined step that occurs after virus
attachment and before the fusion of the viral and cell membranes
{[}11{]}.

In a phase 3 clinical trial, conducted in in four countries the United
States, Canada, Brazil, and Spain between August 27, 2020 and March 4,
2021 {[}12{]} where the circulating COVID-19 variant was predominantly
Delta variant in the US, Sotrovimab showed a significant reduction in
the risk of COVID-19 progression among high-risk ambulatory patients
with mild to moderate disease {[}12{]}. Patients who received Sotrovimab
had 85\% lower rates of hospitalization for \textgreater{} 24 hours for
any cause or death at day 29 compared with the placebo arm {[}12{]}.
Subsequently, Sotrovimab received emergency use authorization from the
Food and Drug Administration (FDA) and preliminary approval from the
European Medicine Agency (EMA) in May 2021 {[}11{]} . The American
National Institute of Health (NIH) included IV Sotrovimab infusion as
one of the therapeutic options recommended for outpatients with mild to
moderate COVID-19 who are at high risk for disease progression {[}9{]}.
More recently , with the rise and spread of the Omicron variant, it
became obvious that Sotrovimab is not effective against it and its
subvariants {[}13{]}.

Real-life experience about the effectiveness of Sotrovimab is limited.
In Lebanon, the COVID-19 response was particularly challenging as it
happened amid an unprecedented economic crisis and political turmoil,
aggravated by the catastrophic Beirut port explosion of August 4, 2020
{[}14{]}. All those factors added to the challenges of the pandemic,
severely affected medical supplies and drug availability in the country,
and resulted in critical shortages of various medications including
essential COVID-19 therapies {[}14{]}. The American University of Beirut
Medical Center (AUBMC) is a university tertiary care hospital in Beirut,
Lebanon and was one of the tertiary medical centers who cared for a
large number of COVID-19 patients. The hospital received donations of
various drugs including 62 doses of Sotrovimab. In this study, we set to
evaluate the efficacy of Sotrovimab in preventing COVID-19
hospitalizations and other patient-related outcomes, as well as its
appropriateness of use at AUBMC.

\textbf{Methodology:}

This is a retrospective observational study conducted at AUBMC. We
included adult patients ([?] 18 years) with a positive test result for
SARS-CoV-2 polymerase-chain-reaction or rapid antigen test who received
IV Sotrovimab either in the Emergency Department (ED) upon presentation
or during hospitalization for hospital-acquired COVID-19 from November
2021 through March 2022.

Due to the limited supply, Sotrovimab was prioritized for
immunocompromised patients who were unvaccinated against COVID-19 or
those who were fully or partially vaccinated but were not expected to
mount an adequate immune response to the vaccine. We developed criteria
for the use of Sotrovimab based on the NIH guidelines. As such, only
patients with a high risk of disease progression were eligible to
receive Sotrovimab after the approval of two infectious disease
attending physicians. Major risk factors for clinical progression
included: age ([?] 65 years), obesity (BMI [?] 30), immune suppression,
cardiovascular disease (including congenital heart disease) or
hypertension, and chronic lung diseases (i.e., Chronic Obstructive
Pulmonary Disease (COPD), moderate to severe asthma, interstitial lung
disease, cystic fibrosis, and pulmonary hypertension). Other risk
factors contributing to disease progression were CKD, pregnancy, sickle
cell disease, and neurodevelopmental disorders.

The collected data included patient demographics such as COVID-19
vaccination status, clinical characteristics (e.g., duration of
symptoms, risk factors for disease progression), history of use of other
monoclonal antibodies and concurrent immunosuppressive medications, data
related to the use of Sotrovimab (e.g., dosing regimen, administration,
drug interactions), and outcomes. This study was approved by the
Institutional Review Board of the AUBMC. The requirement for informed
consent was waived because of the retrospective nature of the study.
Patient anonymity and privacy were respected by deleting all subjects'
identifiers such as medical record number and full name from the data
collection sheet and each subject received a unique identifier number
for data collection purposes.

Primary outcomes were hospitalization, deterioration after 24 hours, and
death due to any cause at day 60 after the Sotrovimab infusion.
Hospitalized patients were further classified into those who were
already admitted to the hospital for a reason other than COVID-19 and
those who were hospitalized due to COVID-19. Patient deterioration was
defined as oxygen saturation SpO2 [?] 94\% on room air and/or the need for
supplemental oxygen. Secondary outcomes were progression to critical
illness and adverse events. Critical illness was defined as patients on
mechanical ventilation and/or extracorporeal mechanical oxygenation
(ECMO). It also included -end-organ dysfunction as seen in sepsis/septic
shock and acute respiratory distress syndrome (ARDS).

The appropriateness of Sotrovimab use was assessed as well, since the
drug was recently added to the institution's formulary. The use of
Sotrovimab was restricted to patients that met the above criteria. Each
prescription order was reviewed by the pharmacist to verify the
patients' eligibility in addition to securing the required approval of
two infectious diseases (ID) physicians. The appropriateness of use was
assessed by collecting data related to indication, dosing regimen,
administration route, rate of infusion, and contraindications. Drug-drug
interactions were screened, and any adverse drug events were reported.

Descriptive statistics were used. Continuous variables were expressed by
mean values and standard deviations (SD). Categorical variables were
expressed as frequencies and percentages. Data were analyzed using
Statistical Package for Social Sciences (SPSS) v.25.

\textbf{Results:}

Between November 2021 and March 2022, a total of 62 subjects received
Sotrovimab infusion at AUBMC. Patients had a mean age of 59.7 years and
an average Body Mass Index (BMI) of 26.72 Kg/m\textsuperscript{2}. Most
of the patients were males (66.1\%), and almost half were smokers
(51.6\%).

More than 70\% of subjects were vaccinated against COVID-19 (Pfizer
AstraZeneca, Sinopharm, and other various vaccines), and 25 (43.1\%) out
of 62 had received two doses of any COVID-19 vaccine. The average
duration of symptoms before hospital presentation was 3.97\selectlanguage{ngerman}±4.5 days. The
baseline characteristics are shown in \textbf{Table 1.}

Regarding patient comorbidities\textbf{,} hypertension was the most
common and was present in 56.5\% of subjects, followed by hematological
malignancies with a rate of 35.5\%. The prevalence rates of all
comorbidities are listed in \textbf{(Figure1)} ,

The subject population was grouped according to the NIH criteria for
prioritizing the use of anti-SARS-CoV-2 therapies {[}15{]} and it was
found that 77\% of the population belonged to Tier 1, 8.1 \% to Tier 2,
and 14.5 \% to Tier 3 \textbf{(Table 2)} .

Concerning the ongoing chronic treatment of the subjects, 40.3\% of the
62 subjects were on active chemotherapy and 17.7\% of them were
currently receiving or previously received rituximab within the past 12
months \textbf{(Table 3)} .

We calculated the primary and the secondary outcomes using SPSS by
adding the patients with the specific outcome to generate the total
number (N) and we divided them by the total number of patients to get
the percentage (\%). For the primary outcomes, 39 subjects received the
drug in the ED and did not require hospitalization (62.9\%). 23 subjects
(37.1\%) were hospitalized: 13 of them required hospitalization due to
COVID- 19 (and received Sotrovimab subsequently), whereas the other 10
patients were already hospitalized when they acquired COVID-19
infection. Thirteen patients (21.0\%) experienced clinical deterioration
24 hours after Sotrovimab infusion and only four patients (6.5\%) died
due to any cause at 60 days after the infusion. For the secondary
outcomes, six patients (9.7\%) out of the total subjects progressed to
critical illness and no adverse events were reported in any of the
subjects \textbf{(Table-4).}

Concerning the appropriateness of Sotrovimab use based on the
institution criteria developed as mentioned above, we found that
Sotrovimab administration was appropriate and in compliance with the
NIH-derived institution criteria in 61 out of the 62 (98.4\%) patients.

\textbf{Discussion:}

This study included 62 subjects who tested positive for COVID-19 and
received Sotrovimab infusion within an average of 4 days of symptoms
onset between November 2021 and March 2022 at AUBMC. To our knowledge,
this study is the second one from the Middle East, the first one was
conducted in United Arab Emirates (UAE) {[}16{]}, describing real-life
experience with Sotrovimab as treatment in patients with COVID-19. And
it is the first study that includes a high proportion of cancer
patients.

Most of our subjects were classified as tier 1 priority as per NIH
criteria as patients in this tier were at the highest risk for disease
progression. As compared to other cohorts in the earlier Sotrovimab
clinical trials {[}12, 16-17{]}, more patients in our study had
hematological malignancies and/or were receiving active chemotherapy.
Moreover, more than 50\% (63.4\%=27.9+35.5) of our patient population
had cancer, whether hematological malignancy or solid organ malignancy
and those are considered high-risk subjects and at risk for severe
COVID-19 disease and death {[}18{]}. In the study from UAE only 1\% of
the subjects in the Sotrovimab group were immunosuppressed {[}16{]}.
Whereas in the study by Aggarwal et al 24.9\% of the subjects who
received Sotrovimab were immunosuppressed {[}19{]}.

Before the use of Sotrovimab, COVID-19 was associated with serious
complications in cancer patients. In fact, the percentage of
hospitalization among cancer patients who were infected with COVID-19 in
the U.S varied between 25.2\% and 33.7\% {[}20{]}. And, in a study from
China, the percentage of clinical deterioration and intensive care unit
(ICU) admission in this patient population was reported as 39\%
{[}21{]}.

In our cohort, we found that 21\% of the subjects required
hospitalization after receiving Sotrovimab, and 21 \% had clinical
deterioration within 24 hours of Sotrovimab infusion even though most of
our subjects were cancer patients. Those rates were higher compared to
the previously published trials {[}12, 19{]}. In the study from UAE, the
overall hospitalization was 3.9\%, and the percentage of critical
disease progression was 0\% {[}16{]}. However, patients who received
Sotrovimab in the UAE study were selected based on a risk stratification
criterion with at least one risk factor for disease progression, and the
most prevalent risk factor for disease progression among patient who
received Sotrovimab infusion was overweight 36\% followed by HTN 20 \%
{[}16{]} and both percentages were much lower than the risk factors
percentages in our cohort where 63.2 \% of our subjects were obese and
56.5 \% had HTN.

In a recent study from Sao Paulo Brazil the mortality rate among cancer
patients who were hospitalized for COVID-19 was 49\% without Sotrovimab
{[}22{]}. The mortality rate in our study was much lower at 6.5\% but
still higher than the mortality rate among patients who received
Sotrovimab in the studies that included less cancer patients such as the
study from UAE {[}16{]} and that from Aggarwal et al {[}19{]}.

The difference in the findings is mainly due to the overall proportion
of immune suppressed subjects in the various studies and whether the NIH
prioritization criteria were applied or not.

In our series, no adverse events related to Sotrovimab infusion were
reported compared to 2\% Sotrovimab related adverse events in the COMET
ICE clinical trial and 10\% in the TICO trial {[}12, 17{]}.

Another point of relevance in this study is the very high compliance
with the set criteria for use of Sotrovimab developed at our institution
by the concerned stakeholders including ID specialists and pharmacists.
Despite the chaos in Lebanon and the many challenges faced in all health
care institutions {[}14{]}, the Antimicrobial Stewardship Program at
AUBMC has high level expertise in developing institutional policies, and
guidelines for various diseases including COVID-19 with a tight control
on the use of various agents including the monoclonal antibodies. The
program follows patients closely to ensure adherence and compliance to
various medications use.

Our study has several limitations. First, it is a retrospective study
and not all the data needed was available in the reviewed charts. Also,
the sample size is small, given the limited number of available
Sotrovimab doses. It included vaccinated patients, and vaccination was
not homogenous among the cohort and the subjects received different
types of vaccines. In addition, our study was not homogenous in terms of
management and treatment options for COVID-19 infection (concomitant use
of remdesivir, steroids, and tocilizumab). As a result, the
generalizability of the findings of the study is limited. Another
limitation is the fact that the SARS-CoV-2 variant type of each subject
was not identified; this information would have been important in light
of several reports of a decreased efficacy of Sotrovimab against Omicron
variants of COVID-19 {[}13{]}.

\textbf{Conclusion:}

Research on COVID-19-related treatment can guide clinicians in their
practice. This study, in addition to several others published in the
literature, proves that COVID-19 monoclonal antibodies, such as
Sotrovimab, are effective against COVID-19 infection when given early in
the course of the disease, and may contribute to preventing mortality
and complications in high-risk individuals. This study paves the way to
conduct larger trials on special groups of subjects with
immune-compromising conditions and, to study groups that represent the
population, in order to further assess the benefit of monoclonal
antibodies and identify patients who would benefit the most from their
use. The availability of Sotrovimab at our hospital was made possible
through a generous donation and its use generated positive outcomes.
This emphasizes the need to support low-income countries so that
patients around the world can benefit from the therapeutic advances made
in the management of COVID-19.

\textbf{Declaration:}

\begin{itemize}
\tightlist
\item
  \textbf{Ethics approval and consent to participate:} This study was
  approved by the Institutional Review Board of the AUBMC. The
  requirement for informed consent was waived because of the
  retrospective nature of the study.
\item
  \textbf{Availability of data and material} : The data that support the
  findings of this study are available from the corresponding author
  upon reasonable request.
\item
  \textbf{Competing interests:} No competing interest
\item
  \textbf{Funding:} No funding
\item
  \textbf{Acknowledgments and Author contributions:}
\end{itemize}

\begin{enumerate}
\tightlist
\item
  Conceptualization: S. Nahhal sn69@aub.edu.lb\textbf{, N.} Rizk
  nr00@aub.edu.lb, C. El-Halabi ce49@aub.edu.lb
\item
  Methodology: S. Nahhal, N. Rizk, S.Kanj: sk11@aub.edu.lb , R. Zeenny:
  rz37@aub.edu.lb\textbf{,}C. El-Halabi, N. Haddad:
  nh126@aub.edu.lb\textbf{,}AR . Bizri : ab00@aub.edu.lb
\item
  Formal analysis: R. Zeenny: rz37@aub.edu.lb\textbf{,}C. El-Halabi,
\item
  Data collection: S. Nahhal. C. El-halabi, N. Haddad
\item
  Resources: R. Zeenny, G. Khoury: gk08@aub.edu.lb
\item
  Writing---original draft preparation: S. Nahhal, C. El-Halabi, N.
  Haddad, N. Rizk
\item
  Writing---review and editing: S. Kanj, R. Zeenny, AR Bizri, G. Khoury
\item
  Visualization: R. Zeenny, S. Nahhal
\item
  All authors have read and agreed to the published version of the
  manuscript.
\end{enumerate}

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JCO Global Oncology. 2021(7):1084-92.

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\verb`Table 2.docx`  available at \url{https://authorea.com/users/622865/articles/645819-real-life-experience-with-monoclonal-antibody-sotrovimab-in-high-risk-covid-19-patients-a-retrospective-study-in-a-lebanese-tertiary-care-university-hospital}

\textbf{Hosted file}

\verb`Table 3.docx`  available at \url{https://authorea.com/users/622865/articles/645819-real-life-experience-with-monoclonal-antibody-sotrovimab-in-high-risk-covid-19-patients-a-retrospective-study-in-a-lebanese-tertiary-care-university-hospital}

\textbf{Hosted file}

\verb`Table 4.docx`  available at \url{https://authorea.com/users/622865/articles/645819-real-life-experience-with-monoclonal-antibody-sotrovimab-in-high-risk-covid-19-patients-a-retrospective-study-in-a-lebanese-tertiary-care-university-hospital}

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