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.