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 > 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.