Retrospective Case-Control Study of REGEN-COV (Casirivimab and Imdevimab) Therapy for Patients with COVID-19 and Cancer Using the United States MarketScan® Database.

INTRODUCTION: Patients with cancer may be at a higher risk of experiencing severe complications from coronavirus disease 2019 (COVID-19) than are patients without cancer. This study evaluated the efficacy of REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, for treating COVID-19 in patients with cancer in the USA. METHODS: Using the MarketScanⓇ database, de-identified data of patients with a COVID-19 diagnosis between November 1, 2020, and November 30, 2021, were analyzed. In the preliminary study, patients with COVID-19 were divided into two groups: those with and without cancer within 1 year prior to a COVID-19 diagnosis. In the main study, patients with COVID-19 with cancer were divided into two groups: those with and without REGEN-COV treatment. Patient outcomes, such as COVID-19-derived hospitalization, hospitalization duration, and medical costs, were assessed between these two groups by propensity score matching. RESULTS: Within the first 30 days of a COVID-19 diagnosis, the group treated with REGEN-COV had fewer hospitalizations (3.2% vs. 13.3%; p < 0.001), fewer mean hospitalization days (0.2 vs. 1.1 days; p < 0.001), and a lower mean-associated medical payment (2,709 vs. 8,120 USD; p < 0.001) than the group not treated with REGEN-COV. Patients with specific cancer types, including non-Hodgkin's lymphoma, leukemia, and lung cancer, had higher hospitalization rates than those with other cancer types. CONCLUSION: Patients with cancer treated with REGEN-COV experienced a decreased risk for hospitalization, hospitalization duration, and total COVID-19-related costs. Patients with cancer were at a higher risk of being hospitalized for COVID-19 than were those without cancer. The use of neutralizing antibody therapy may reduce the risk of severe COVID-19 infection for patients with cancer with an otherwise high risk. Future replication studies should be conducted using other databases that include Medicaid users and other insured persons for comparison and validation.

Efficacy and safety of casirivimab and imdevimab for preventing and treating COVID-19: a systematic review and meta-analysis.

Background: The ongoing global epidemic of coronavirus disease 2019 (COVID-19) has created a serious public health problem. The selection of safe and effective therapeutic agents is of paramount importance. This systematic review aims to evaluate the efficacy and safety of the combination of casirivimab and imdevimab in the treatment of global cases of COVID-19. Methods: To identify randomized controlled trials (RCTs) investigating the combined administration of casirivimab and imdevimab for COVID-19 management, a comprehensive search was conducted across multiple databases including PubMed, Web of Science, Embase, and the Cochrane Library from their inception to September 10, 2022. Data on the efficacy and safety of casirivimab and imdevimab were extracted. Subgroup analyses and sensitivity analyses were performed. Results: A total of 851 articles were searched. Twelve studies were finally included in the meta-analysis, with 27,179 participants. Dichotomous and continuous variables were presented as odds ratios (ORs) and weighted mean differences (WMDs) with their 95% confidence intervals (CIs), respectively. Compared to placebo or alternative medications, the combination of casirivimab and imdevimab reduced viral load (WMD: -0.73, 95% CI: -1.09 to -0.38, P<0.01), all-cause mortality (OR =0.90, 95% CI: 0.82-0.99, P=0.03), the incidence of any serious adverse events (OR =0.80, 95% CI: 0.67-0.95, P=0.01), the incidence of Grade 3 or more severe adverse events (OR =0.76, 95% CI: 0.62-0.92, P=0.01), the likelihood of contracting COVID-19, the incidence of hospitalization, emergency room visits, and mortality (OR =0.54, 95% CI: 0.32-0.93, P=0.03). Conclusions: The monoclonal antibody combination of casirivimab and imdevimab is effective in treating patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as they can reduce viral load, all-cause mortality, infection rates, and the incidence of clinical outcomes of special interest after treatment, while maintaining a favorable safety profile.

Comparing the efficacy of regen-cov, remdesivir, and favipiravir in reducing invasive mechanical ventilation need in hospitalized COVID-19 patients.

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic stimulates research works to find a solution to this crisis from starting 2020 year up to now. With ending of the 2021-year, various advances in pharmacotherapy against COVID-19 have emerged. Regarding antiviral therapy, casirivimab and imdevimab antibody combination is a type of new immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes Remdesivir and Favipiravir. AIM: To evaluate the efficacy of antibodies cocktail (casirivimab and imdevimab) compared to standard antiviral therapy in reducing the need for invasive mechanical ventilation (IMV). METHODS: 265 COVID-19 polymerase chain reaction confirmed patients with indication for antiviral therapy were included in this study and were divided into 3 groups (1: 2: 2): Group A: REGN3048-3051 antibodies cocktail (casirivimab and imdevimab), group B: Remdesivir, group C: Favipiravir. The study design is a single-blind non-randomized controlled trial Mansoura University Hospital owns the study's drugs. The duration of the study was about 6 mo after ethical approval. RESULTS: Casirivimab and imdevimab achieve less need for O2 therapy and IMV, with less duration of this need than remdesivir and favipiravir. CONCLUSION: Group A (casirivimab and imdevimab) achieve better clinical outcomes than groups B (remdesivir) and C (favipiravir) intervention groups.

Study to compare the effect of casirivimab and imdevimab, remdesivir, and favipiravir on progression and multi-organ function of hospitalized COVID-19 patients.

Coronavirus disease 2019 (COVID-19) caused a progress in research to find a solution to this pandemic. Also, various advances in pharmacotherapy against COVID-19 have emerged. Regarding antiviral therapy, casirivimab and imdevimab are antibodies combination against COVID-19. Standard antiviral therapy against COVID-19 includes remdesivir and favipiravir. The objectives were to compare progression and multi-organ function of hospitalized COVID-19 patients between these three antiviral groups. 265 COVID-19 hospitalized patients were included in this study and were divided into 3 groups (1:2:2), respectively, Group (A): casirivimab and imdevimab, group (B): remdesivir, and group (C): favipiravir. The design of the study is a single blind non-randomized controlled trial. This study is a phase IV clinical trial (post-marketing study). The duration of the study was about 6 months after receiving the ethical approval. Casirivimab and imdevimab achieved less case progression as presented by lower World Health Organization scale (P < 0.05 in comparing group A with B and C) and better multi-organ functions as presented by lower Sequential Organ Function Assessment score (P < 0.05 in comparing group A with B and C) than remdesivir and favipiravir. From all these results, it is concluded that Group A (casirivimab and imdevimab) produces better outcomes than B (remdesivir) and C (favipiravir) intervention groups.

Clinical study to compare the efficacy and safety of casirivimab & imdevimab, remdesivir, and favipravir in hospitalized COVID-19 patients.

Background: Corona Virus disease - 2019 (COVID-19) disease induces scientific research to find a control to this pandemic from 2020 year up to now. Recently, various advances in pharmacotherapy against COVID-19 have emerged. Objectives: To compare the efficacy and safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir, and Favipravir in the COVID-19 patients. Study design: This study is a single-blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are prescribed by lectures on chest diseases, faculty of medicine-Mansoura University. The duration of the study is about six months after ethical approval.265 hospitalized COVID-19 patients were used to represent the COVID-19 population and were assigned into three groups in a ratio of (1:2:2) respectively, Group (A) received REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab)), group (B) received remdesivir, and group (C) received favipravir. Results: Casirivimab and imdevimab achieve less 28-day mortality rate, and less mortality at hospital discharge than Remdesivir, and Favipravir. Conclusion: From all of these results, it is concluded that Group A (Casirivimab & imdevimab) achieves more favorable outcomes than B (Remdesivir) & C (Favipravir) intervention groups. Clinical trial registration: NCT05502081, 16/08/2022, Clinicaltrials.gov.

Impact of a subcutaneous casirivimab and imdevimab clinic in outpatients with symptomatic COVID-19: A single-center, propensity-matched cohort study.

PURPOSE: To evaluate the success of a clinic for subcutaneous administration of casirivmab and imdevimab (REGEN-COV; Regeneron) for treatment of patients with symptomatic mild to moderate coronavirus disease 2019 (COVID-19) in terms of preventing disease progression and healthcare utilization. METHODS: This retrospective single-center, propensity-matched cohort study examined healthcare utilization outcomes for patients who received subcutaneous casirivimab and imdevimab at a pharmacist-led clinic of an academic health system. Eligible patients were treated between August 1, 2021, and January 5, 2022, and were at high risk for COVID-19 disease progression. Treatment patients were propensity matched with high-risk control patients with a diagnosis of COVID-19 in the same timeframe who did not receive casirivimab and imdevimab. Patients were followed for 30 days for collection of data on inpatient admissions, emergency department visits, and mortality. Risk of a 30-day healthcare utilization event was assessed and tested for statistical significance utilizing McNemar's test. RESULTS: A total of 585 patients who received treatment with subcutaneous casirivimab and imdevimab were matched with 585 patients who did not receive casirivimab and imdevimab therapy. Patients who received casirivimab and imdevimab had significantly lower risk of a 30-day all-cause inpatient admission event than untreated patients (relative risk reduction, 62.4%; P < 0.0001). Treated patients also had a significantly lower risk of 30-day all-cause emergency department visit than untreated subjects (relative risk reduction, 36.5%; P = 0.0021). There were 6 mortality events in the untreated group and no mortality events in the treatment group. CONCLUSION: This study provides evidence for the effectiveness of a subcutaneous casirivimab and imdevimab clinic in preventing progression of symptomatic mild to moderate COVID-19.

Monoclonal Antibody Use for Coronavirus Disease 2019 in Pediatric Patients: A Multicenter Retrospective Study.

Monoclonal antibodies for COVID-19 are authorized in high-risk patients aged ≥12 years, but evidence in pediatric patients is limited. In our cohort of 142 patients treated at seven pediatric hospitals between 12/1/20 and 7/31/21, 9% developed adverse events, 6% were admitted for COVID-19 within 30 days, and none received ventilatory support or died.

Successful treatment of persistent and severe SARS-CoV-2 infection in a high-risk chronic lymphocytic leukemia patient using Ronapreve™ antibodies.

Patients with lymphoproliferative diseases are at an increased risk of an incomplete immune response following vaccination or SARS-CoV-2 infection and might develop persistent viral infection and severe COVID-19 disease. We present a case of successful treatment of persistent and mechanical-ventilation-requiring SARS-CoV-2 infection in a del17+ CLL patient using exogenous antibodies.

Regen-Cov and Covid-19, Update on the Drug Profile and Fda Status: A Mini-Review and Bibliometric Study.

COVID-19 is caused by coronavirus (SARS-CoV-2) is a worldwide health crisis. This severe acute respiratory syndrome was declared an outbreak after the first case was reported in Wuhan, the capital city of Hubei Province in China. On March 11th, 2020, the World Health Organization (WHO) declared it as a pandemic. The pharmaceutical treatment of COVID-19 has garnered significant critical attention due to the unavailability of medications to treat COVID-19. Recently, researchers have shown an increased interest in the monoclonal antibody drugs to treat COVID-19 especially REGEN-COV (casirivimab and imde-vimab). This review aims to highlight the relation between the drug and COVID-19 and the recently updated information on the monoclonal antibody REGEN-COV from the U.S. Food and Drug Administration and other authorities. It is also designed to focus on the bibliometric data of REGEN-COV for the last three years (2020, 2021, and 2021) in PubMed and Google Scholar.

Acute Hypersensitivity Reaction After Casirivimab/Imdevimab Infusion in a COVID-19-Positive Young Male: Myopericarditis or Kounis Syndrome?

Myocarditis has been a rare, but well-documented side effect of the mRNA-based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as well as a complication of viral infections including SARS-CoV-2. However, myopericarditis as a complication of monoclonal antibody infusion or as a complication of allergic reaction to antibody infusions might be underreported. We report the case of a 30-year-old man with a previous diagnosis of coronavirus disease 2019 (COVID-19) infection one week prior to presentation, unvaccinated for SARS-CoV-2, who was referred from a monoclonal infusion center where he received casirivimab/imdevimab and 15 minutes after the infusion began to complain of chills, chest pain, shortness of breath, and was hypotensive. In the infusion center, the patient received epinephrine and diphenhydramine and was directed to the ER, where the patient was febrile, tachycardic, and hypotensive. Initial troponin was 1.91 which peaked at 11.73 and CK-MB which peaked at 21.2. EKG had no ischemic changes. A two-dimensional echocardiogram showed an ejection fraction (EF) of about 45%, with a left ventricular dysfunction and trivial posterior pericardial effusion, and it was diagnosed as myopericarditis. On admission, he was started on full-dose enoxaparin, aspirin, fluid resuscitation, steroids, remdesevir, and bilevel positive airway pressure (BiPap) due to his respiratory compromise. Three days later, with clinical improvement, a repeat echocardiogram showed EF of 65%, with normal ventricular contractility and no pericardial effusion. The patient was discharged home with close cardiology follow-up. Though this could be a simple case of viral myopericarditis with troponinemia secondary to demand-ischemia, the differential should be broadened to complication of monoclonal antibody, given the sudden symptom onset after infusion completion and/or a possible Kounis syndrome. Though there have not been any reported cases of casirivimab/imdevimab causing myopericarditis, adverse cardiac events after monoclonal therapy have been reported mainly in cancer patients receiving monoclonal infusions.

Monoclonal antibody therapies in the management of SARS-CoV-2 infection.

INTRODUCTION: Neutralizing antibodies (NAbs) that target key domains of the spike protein in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may have therapeutic value because of their specificity. Depending on the targeted epitope, single agents may be effective, but combined treatment involving multiple NAbs may be necessary to prevent the emergence of resistant variants. AREAS COVERED: This article highlights the accelerated regulatory processes established to facilitate the review and approval of potential therapies. An overview of treatment approaches for SARS-CoV-2 infection, with detailed examination of the preclinical and clinical evidence supporting the use of NAbs, is provided. Finally, insights are offered into the potential benefits and challenges associated with the use of these agents. EXPERT OPINION: NAbs offer an effective, evidence-based therapeutic intervention during the early stages of SARS-CoV-2 infection when viral replication is the primary factor driving disease progression. As the pandemic progresses, appropriate use of NAbs will be important to minimize the risk of escape variants. Ultimately, the availability of effective treatments for COVID-19 will allow the establishment of treatment algorithms for minimizing the substantial rates of hospitalization, morbidity (including long COVID) and mortality currently associated with the disease.

Casirivimab and Imdevimab Treatment Reduces Viral Load and Improves Clinical Outcomes in Seropositive Hospitalized COVID-19 Patients with Nonneutralizing or Borderline Neutralizing Antibodies.

We conducted a post hoc analysis in seropositive patients who were negative or borderline for functional neutralizing antibodies (NAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at baseline from a phase 1, 2, and 3 trial of casirivimab and imdevimab (CAS+IMD) treatment in hospitalized coronavirus disease 2019 (COVID-19) patients on low-flow or no supplemental oxygen prior to the emergence of Omicron-lineage variants. Patients were randomized to a single dose of 2.4 g CAS+IMD, 8.0 g CAS+IMD, or placebo. Patients seropositive for anti-SARS-CoV-2 antibodies at baseline were analyzed by their baseline neutralizing antibody status. At baseline, 20.6% (178/864) of seropositive patients were negative or borderline for neutralizing antibodies, indicating negative or very low functionally neutralizing anti-SARS-CoV-2 antibodies. CAS+IMD reduced viral load in patients who were negative or borderline for neutralizing antibodies versus placebo, but not in patients who were positive for neutralizing antibodies. In patients who were negative or borderline for neutralizing antibodies, we observed a trend in reduction of the proportion of patients who died or required mechanical ventilation, as well as in all-cause mortality, by day 29 with CAS+IMD versus placebo. The proportions of patients who died or required mechanical ventilation from days 1 to 29 were 19.1% in the placebo group and 10.9% in the CAS+IMD combined-dose group, and the proportions of patients who died (all-cause mortality) from days 1 to 29 were 16.2% in the placebo group and 9.1% in the CAS+IMD combined-dose group. In patients who were positive for neutralizing antibodies, no measurable harm or benefit was observed in either the proportion of patients who died or required mechanical ventilation or the proportion of patients who died (all-cause mortality). In hospitalized COVID-19 patients on low-flow or no supplemental oxygen, CAS+IMD reduced viral load, the risk of death or mechanical ventilation, and all-cause mortality in seropositive patients who were negative or borderline for neutralizing antibodies. IMPORTANCE The clinical benefit of CAS+IMD in hospitalized seronegative patients with COVID-19 has previously been demonstrated, although these studies observed no clinical benefit in seropositive patients. As the prevalence of SARS-CoV-2-seropositive individuals rises due to both vaccination and previous infection, it is important to understand whether there is a subset of hospitalized patients with COVID-19 with antibodies against SARS-CoV-2 who could benefit from anti-SARS-CoV-2 monoclonal antibody treatment. This post hoc analysis demonstrates that there is a subset of hospitalized seropositive patients with inadequate SARS-CoV-2-neutralizing antibodies (i.e., those who were negative or borderline for neutralizing antibodies) who may still benefit from CAS+IMD treatment if infected with a susceptible SARS-CoV-2 variant. Therefore, utilizing serostatus alone to guide treatment decisions for patients with COVID-19 may fail to identify those seropositive patients who could benefit from anti-SARS-CoV-2 monoclonal antibody therapies known to be effective against circulating strains, dependent upon how effectively their endogenous antibodies neutralize SARS-CoV-2.

Casirivimab/Imdevimab for Active COVID-19 Pneumonia Which Persisted for Nine Months in a Patient with Follicular Lymphoma during Anti-CD20 Therapy.

Immunocompromised patients are more likely to develop severe COVID-19, and exhibit high mortality. It is also hypothesized that chronic infection in these patients can be a risk factor for developing new variants. We describe a patient with prolonged active infection of COVID-19 who became infected during treatment with an anti-CD20 antibody (obinutuzumab) for follicular lymphoma. This patient had persistent RT-PCR positivity and live virus isolation for nine months despite treatment with remdesivir and other potential antiviral therapies. The computed tomography image of the chest showed that the viral pneumonia repeatedly appeared and disappeared in different lobes, as if a new infection had occurred continuously. The patient's SARS-CoV-2 antibody titer was negative throughout the illness, even after two doses of the BNT162b2 mRNA vaccine were administered in the seventh month of infection. A combination of monoclonal antibody therapy against COVID-19 (casirivimab and imdevimab) and antivirals resulted in negative RT-PCR results, and the virus was no longer isolated. The patient was clinically cured. During the 9-month active infection period, no fixed mutations in the spike (S) protein were detected, and the in vitro susceptibility to remdesivir was retained. Therapeutic administration of anti-SARS-CoV-2 monoclonal antibodies is essential in immunocompromised patients. Therefore, measures to prevent resistance against these key drugs are urgently needed.

Updated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents.

BACKGROUND: Starting in November 2020, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for multiple novel virus-neutralizing monoclonal antibody therapies, including bamlanivimab monotherapy (now revoked), bamlanivimab and etesivimab, casirivimab and imdevimab (REGEN-COV), and sotrovimab, for treatment or postexposure prophylaxis of Coronavirus disease 2019 (COVID-19) in adolescents (≥12 years of age) and adults with certain high-risk conditions. Previous guidance is now updated based on new evidence and clinical experience. METHODS: A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacotherapy, and pediatric critical care medicine from 18 geographically diverse US institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on a review of the best available evidence and expert opinion. RESULTS: The course of COVID-19 in children and adolescents is typically mild, though more severe disease is occasionally observed. Evidence supporting risk stratification is incomplete. Randomized controlled trials have demonstrated the benefit of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-specific monoclonal antibody therapies in adults, but data on safety and efficacy in children or adolescents are limited. Potential harms associated with infusion reactions or anaphylaxis are reportedly low in adults. CONCLUSIONS: Based on evidence available as of August 31, 2021, the panel suggests a risk-based approach to administration of SARS-CoV-2 monoclonal antibody therapy. Therapy is suggested for the treatment of mild to moderate COVID-19 in adolescents (≥12 years of age) at the highest risk of progression to hospitalization or severe disease. Therapeutic decision-making about those at moderate risk of severe disease should be individualized. Use as postexposure prophylaxis could be considered for those at the highest risk who have a high-risk exposure but are not yet diagnosed with COVID-19. Clinicians and health systems should ensure safe and timely implementation of these therapeutics that does not exacerbate existing healthcare disparities.

Use of Casirivimab and Imdevimab for the Treatment of COVID-19.

The authors present three cases of unvaccinated coronavirus disease 2019 (COVID-19) patients who exhibited symptoms of fever, sore throat, nausea, diarrhea, congestion, and headache. Although they refused COVID-19 vaccination, they presented for the casirivimab and imdevimab monoclonal antibody cocktail, which resulted in the resolution of all symptoms. The authors describe the mechanisms and importance of monoclonal antibody treatment for high-risk and unvaccinated patients infected with SARS-CoV-2.

Outcomes of pregnant patients treated with REGEN-COV during the COVID-19 pandemic.

BACKGROUND: Pregnant patients with SARS-CoV-2 infection are at increased risk for severe disease including hospitalization, intensive care admission, ventilatory support, and death. Although pregnant patients were excluded from investigational trials for pharmacologic treatments for COVID-19 illness, the National Institutes of Health treatment guidelines state that efficacious treatments should not be withheld from pregnant patients. An infusion of casirivimab and imdevimab (REGEN-COV), a monoclonal antibody therapy, was shown to reduce the risk of COVID-19-related hospitalization or death from any cause and resolved symptoms and reduced SARS-CoV-2 viral load more rapidly than placebo. In July of 2021, the Food and Drug Administration released an Emergency Use Authorization for REGEN-COV. Although pregnant persons were not included in the original trials, given the higher risk of morbidity and mortality in the pregnant population, our institution offered REGEN-COV to our pregnant patients beginning in August of 2021. Side effects after REGEN-COV administration are rare and thought to be secondary to COVID-19 rather than REGEN-COV. OBJECTIVE: This study aimed to track safety and clinical outcomes in unvaccinated pregnant patients who received REGEN-COV and to compare these outcomes with those of a contemporary cohort of patients who tested positive for SARS-CoV-2 and were eligible but did not receive REGEN-COV. Our hypothesis was that REGEN-COV administration during pregnancy is safe, and that pregnant persons who received REGEN-COV would experience less severe COVID-19 respiratory illness, with decreased length of hospital stay, rates of intensive care unit admission, and need for oxygen and other COVID-19 therapeutics. STUDY DESIGN: This is a retrospective cohort study of pregnant patients who either tested positive for SARS-CoV-2 or had a known exposure to a COVID-19-positive person, and were therefore eligible for REGEN-COV at our institution. Within this cohort, we compared those who received REGEN-COV with those who did not between March and October of 2021 at Grady Memorial Hospital in Atlanta, Georgia. The main outcomes studied were perinatal outcomes, safety data, and the clinical course of SARS-CoV-2 infection. RESULTS: From March to October of 2021, 86 pregnant people tested positive for SARS-CoV-2 via real-time polymerase chain reaction or had a confirmed exposure. In this group, 36 received REGEN-COV and 50 did not. There were no instances of infusion rate adjustment or discontinuation, anaphylaxis, or death among individuals who received REGEN-COV. One individual experienced worsening shortness of breath >24 hours after administration, which was classified as an infusion-related reaction. There were no significant differences in perinatal outcomes, length of hospitalization, rates of intensive care unit admission, additional pharmacologic treatment for COVID-19, or oxygen requirement between the 2 groups. CONCLUSION: Administration of REGEN-COV is safe in pregnancy and did not increase adverse maternal, neonatal, or obstetrical outcomes. There was not a statistically significant difference in COVID-19-related outcomes in our high-risk population. Given the likely safety of this drug in pregnancy and its known benefits in the nonpregnant population, we advocate for the continued use of this therapy and encourage the development of future studies to enroll a larger and more diverse cohort to explore its efficacy further.

Monoclonal Antibodies for Early Treatment of COVID-19 in a World of Evolving SARS-CoV-2 Mutations and Variants.

Monoclonal antibodies targeting the receptor binding domain (RBD) of severe acute respiratory syndrome coronavirus 2 spike protein are important outpatient treatment options in coronavirus disease 2019 to mitigate progression of disease and prevent hospitalization. The impact of different RBD mutations on the efficacy of the available monoclonal antibodies and processes for incorporating this impact into treatment algorithms are ill defined. Herein, we synthesize the data surrounding the impact of key RBD mutations on the efficacy of US Food and Drug Administration Emergency Use Authorized monoclonal antibodies and describe our approach at Michigan Medicine at monitoring mutation frequency in circulating virus and developing an algorithm that incorporates these data into outpatient treatment pathways.