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Sotrovimab for COVID-19
29 studies with >50,000 patients
Serious outcome risk
Sotrovimab
Control
Significantly lower risk for mortality, ICU, and hospitalization.
17 studies from 15 independent teams in 6 countries show significant benefit.
Efficacy is variant dependent.
COVID-19 Sotrovimab studies · October 2026
Efficacy is variant dependent. In Vitro studies suggest lower efficacy for omicron BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, XBB, XBB.1.5, XBB.1.9.17, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked. mAb use may create new variants that spread globally8-10, and may be associated with increased risk of autoimmune disease11, prolonged viral loads, clinical deterioration, and immune escape9,12-16. Sotrovimab was adopted in 42 countries. Recent:
Luxi
Ashoor
Ngiam.
Covid Analysis Sotrovimab reduced COVID-19 risk: real-time meta-analysis of 29 studies (Version 49)
Significantly lower risk is seen for mortality, ICU admission, and hospitalization. 17 studies from 15 independent teams in 6 countries show significant benefit. Meta-analysis using the most serious outcome reported shows 22% [10R..
Jul 22
 Luxi et al., Drug Safety, doi:10.1007/s40264-026-01705-2 Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase
Disproportionality analysis of 15,250 de-duplicated individual case safety reports from VigiBase (February 2020-December 2023) identifying potential cardiovascular and neurological safety signals for monoclonal antibodies (mAbs) used in e..
Jan 31
 Ngiam et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2026.108435 Early administration of neutralising monoclonal antibodies and post-acute sequelae of COVID-19
Retrospective 19,689 hospitalized COVID-19 patients in Singapore showing no significant reduction in overall post-acute sequelae of COVID-19 (PASC) with early monoclonal antibody treatment, but increased risk of autoimmune complications. ..
Jan 11
 Chen-Xu et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofaf695.340 Sotrovimab for Pre-exposure Prophylaxis against SARS-CoV2 in a Vulnerable Patient Population: Results from the PROTECT-V trial
66% lower mortality (p=1), 66% lower hospitalization (p=0.62), and 20% fewer symptomatic cases (p=0.51). RCT 619 vulnerable patients showing no significant difference in symptomatic COVID-19 infections at 12 weeks with sotrovimab pre-exposure prophylaxis.
Dec 31
2025
 Martin-Blondel et al., iScience, doi:10.1016/j.isci.2025.114226 Viral clearance and escape during therapy of COVID-19 outpatients: A prospective cohort study
Prospective cohort study of 114 high-risk COVID-19 outpatients showing that monoclonal antibody treatments with suboptimal neutralizing activity against infecting variants resulted in higher viral loads and increased emergence of escape m..
Oct 1
2025
 Focosi et al., Infection and Drug Resistance, doi:10.2147/IDR.S540928 The Emergence of Escape Mutations in COVID-19 Following Anti-Spike Monoclonal Antibody Treatment: How Do We Tackle It?
Review of treatment-emergent resistance to anti-spike monoclonal antibodies in COVID-19 patients. Monotherapies like bamlanivimab and sotrovimab showed very high resistance rates, while combination approaches had lower risk. The rapid evo..
Sep 2
2025
 Horby et al., medRxiv, doi:10.1101/2025.08.29.25334732 Long-term follow-up of treatment comparisons in RECOVERY: a randomised, open-label, platform trial for patients hospitalised with COVID-19
6-month followup of RECOVERY patients. Results are reported within the respective trials for each treatment.
May 19
2025
 Breuer et al., Journal of Infection, doi:10.1016/j.jinf.2025.106510 Monitoring the emergence of resistance with sotrovimab in immunocompromised patients with COVID-19: LUNAR study
Prospective study of 217 mostly immunocompromised COVID-19 outpatients in the UK showing viral clearance in 84% by day 28 after sotrovimab treatment, and treatment-emergent substitutions in the sotrovimab epitope in 30% of patients with p..
Mar 22
2025
 Drysdale et al., Infection, doi:10.1007/s15010-025-02505-z Impact of treatment of COVID-19 with sotrovimab on post-acute sequelae of COVID-19 (PASC): an analysis of National COVID Cohort Collaborative (N3C) data
4% lower long COVID (p=0.002). N3C retrospective 9,504 sotrovimab-treated high-risk COVID-19 patients versus 619,668 untreated high-risk controls showing reduced risk of post-acute sequelae of COVID-19 (PASC) with treatment. ATT weighting failed to adjust for "hea..
Mar 18
2025
 Iriyama et al., PNAS Nexus, doi:10.1093/pnasnexus/pgaf085 Clinical and molecular landscape of prolonged SARS-CoV-2 infection with resistance to remdesivir in immunocompromised patients
Clinical and virological study of 3 immunocompromised B-cell lymphoma patients with prolonged SARS-CoV-2 infection showing development of remdesivir and sotrovimab resistance. Through serial viral genome sequencing, authors identified NSP..
Mar 13
2025
 Vukovikj et al., Eurosurveillance, doi:10.2807/1560-7917.ES.2025.30.10.2400252 Impact of SARS-CoV-2 variant mutations on susceptibility to monoclonal antibodies and antiviral drugs: a non-systematic review, April 2022 to October 2024
Review of SARS-CoV-2 variant mutations and their impact on susceptibility to monoclonal antibodies and antivirals. Mutations in the ORF1ab region led to decreased susceptibility to paxlovid, while nsp12 mutations reduced efficacy for remd..
Feb 6
2025
 Mourad et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2025.02.002 Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial
34% higher mortality (p=0.39) and 12% lower combined mortality/hospitalization (p=0.5). Analysis of 2,311 hospitalized COVID-19 patients from four randomized controlled trials (ACTIV-3/TICO) showing no significant difference in long-term mortality with sotrovimab, amubarvimab/romlusevimab, tixagevimab-cilgavimab, or ensovibep.
Jan 29
2025
 Chua et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofae631.2172 Evaluating the use of Monoclonal Antibodies - Sotrovimab, Casirivimab/Imedvimab (REGEN-COV) and Tixagevimab/Cilgavimab (EVUSHELD) for COVID-19 Treatment in Singapore
PSM retrospective 366 hospitalized COVID-19 patients in Singapore showing no statistically significant reduction in severe outcomes with monoclonal antibodies (mAbs), except for lower oxygen use in patients treated with sotrovimab during ..
Jan 27
2025
 Horby et al., Lancet Infectious Diseases, doi:10.1016/S1473-3099(25)00361-5 (date from preprint) Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
6% lower mortality (p=0.47), 4% lower hospital discharge (p=0.51), and 2% lower combined mortality/ICU admission (p=0.82). RCT 1,723 hospitalized COVID-19 patients showing lower 28-day mortality with sotrovimab in patients with high serum nucleocapsid antigen levels, but no significant benefit in the overall population. The trial used a higher dose of sotrovi..
Oct 10
2024
 Ashoor et al., JMIR Bioinformatics and Biotechnology, doi:10.2196/58018 Comparison of the Neutralization Power of Sotrovimab Against SARS-CoV-2 Variants: Development of a Rapid Computational Method
In silico computational method developed to predict the neutralization power of monoclonal antibodies against new SARS-CoV-2 variants. The method evaluates binding affinity of antibodies based on molecular interactions and Gibbs free ener..
Oct 4
2024
 Maria et al., European Journal of Medical Research, doi:10.1186/s40001-024-02062-5 Does early combination vs. Monotherapy improve clinical outcomes of clinically extremely vulnerable patients with COVID-19? Results from a retrospective propensity-weighted analysis
72% lower mortality (p=0.15) and 77% lower progression (p=0.03). Retrospective 81 severely immunocompromised COVID-19 outpatients in Italy showing improved composite outcome of death, hospitalization, and emergency department encounters with early combination therapy of an antiviral plus sotrovimab com..
Sep 19
2024
 Kumar et al., Antiviral Research, doi:10.1016/j.antiviral.2024.106006 Identification of antibody-resistant SARS-CoV-2 mutants via N4-Hydroxycytidine mutagenesis
In vitro selection study identifying SARS-CoV-2 spike mutations that confer resistance to therapeutic antibodies. Using a Wuhan-like strain and omicron B.1.1.529, the authors used sequential mutagenesis with the molnupiravir active compou..
Aug 19
2024
 Ashoor, D., MDPI AG, doi:10.20944/preprints202408.1340.v1 In Silico Evaluation of Ten Monoclonal Antibodies Neutralization Power of SARS-CoV-2 Variants EG.5, BA.2.86 and JN.1
In silico study evaluating the neutralization power of 10 monoclonal antibodies (9 previously EUA-granted, 1 under clinical investigation) against SARS-CoV-2 variants EG.5, BA.2.86, and JN.1. Most available neutralizing antibodies have si..
Aug 12
2024
 Bang et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2024.102512 Sotrovimab lost neutralization efficacy against SARS-CoV-2 subvariants but remained clinically effective: Were monoclonal antibodies against COVID-19 rejected too early?
Retrospective 14 outpatients treated with sotrovimab showing that while sotrovimab lost in vitro neutralization efficacy against omicron subvariants BA.1 and BA.2, it remained clinically effective in reducing viral load in patients who di..
Aug 11
2024
 Focosi, D., Current Topics in Microbiology and Immunology, doi:10.1007/82_2024_268 Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities
Review of monoclonal antibodies for SARS-CoV-2. Author notes that the omicron variant has reset achievements to date.
Aug 8
2024
 Casadevall et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae408 Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship
Review arguing against use of single monoclonal antibodies for COVID-19 treatment, particularly in immunosuppressed patients, due to the risk of rapidly selecting for resistant viral variants. Authors suggest that while monoclonal antibod..
Aug 5
2024
 Enyeji et al., Viral Immunology, doi:10.1089/vim.2024.0034 Effective Treatment of COVID-19 Infection with Repurposed Drugs: Case Reports
Review of the successful treatment of COVID-19 using existing medications including HCQ, AZ, ivermectin, famotidine, monoclonal antibodies, and others. Authors note that the typical treatment of severe viral infections with multiple thera..
Jul 16
2024
 Bell et al., PLOS ONE, doi:10.1371/journal.pone.0304822 Real-world effectiveness of sotrovimab in preventing hospitalization and mortality in high-risk patients with COVID-19 in the United States: A cohort study from the Mayo Clinic electronic health records
50% lower mortality (p=0.2), 12% lower combined mortality/hospitalization (p=0.7), 74% lower ICU admission (p=0.006), and 59% lower need for oxygen therapy (p<0.0001). Retrospective 35,485 high-risk COVID-19 outpatients showing lower ICU admission and respiratory support with sotrovimab. There was no significant difference for hospitalization.
Jun 19
2024
 Farmer et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2024.107136 Real-world evidence of sotrovimab effectiveness for preventing severe outcomes in patients with COVID-19: A quality improvement propensity matched retrospective cohort study of a pan-provincial program in Alberta, Canada
20% higher combined mortality/hospitalization (p=0.2). Retrospective propensity-matched study of 22,289 high-risk COVID-19 outpatients in Canada, showing no significant difference in combined hospitalization/mortality with sotrovimab treatment. In a subgroup analysis of patients with no comor..
Apr 30
2024
 Wang et al., European Review for Medical and Pharmacological Sciences, doi:10.26355/eurrev_202404_35925 The safety signal detection and analysis of monoclonal antibodies against SARS-CoV-2 based on real-world evidence – the suitable selectivity for different populations
FDA adverse event reporting analysis for bebtelovimab, tixagevimab/cilgavimab, and sotrovimab, showing distinct safety profiles with concerning adverse events for each drug. Bebtelovimab showed the highest associations with gastrointestin..
Apr 23
2024
 Amani et al., Immunity, Inflammation and Disease, doi:10.1002/iid3.1262 Comparison of effectiveness and safety of molnupiravir versus sotrovimab for COVID‐19: A systematic review and meta‐analysis
Meta analysis of 13 studies involving 16,166 patients showing higher mortality and higher incidence of adverse events with molnupiravir compared with sotrovimab.
Mar 30
2024
 Hattab et al., Infection, doi:10.1007/s15010-024-02223-y SARS-CoV-2 journey: from alpha variant to omicron and its sub-variants
Review of SARS-CoV-2 variants showing increased transmissibility, disease severity, and immune escape with mutations in the spike protein receptor binding domain. Authors cover variants from the initial D614G mutation through omicron sub-..
Feb 20
2024
 Bell et al., Clinical Drug Investigation, doi:10.1007/s40261-024-01344-4 Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the US National COVID Cohort Collaborative (N3C)
24% lower combined mortality/hospitalization (p=0.0001) and 21% lower hospitalization (p=0.001). N3C retrospective 4,992 high-risk outpatients with mild-to-moderate COVID-19 showing reduced risk of hospitalization or death with sotrovimab treatment compared to 541,325 untreated controls during periods of Delta and Omicron BA.2 varian..
Jan 26
2024
 Wilcock et al., JAMA Health Forum, doi:10.1001/jamahealthforum.2023.5044 Clinical Risk and Outpatient Therapy Utilization for COVID-19 in the Medicare Population
Analysis of Medicare beneficiaries in 2022 showing that outpatient COVID-19 treatments like antivirals and monoclonal antibodies were disproportionately used by patients at lower risk of severe infection and outcomes. Retrospective studie..
Dec 4
2023
 Behzad et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2023.11.029 Real world Effectiveness of Sotrovimab in Preventing COVID-19–related Hospitalisation or Death in Patients Infected with Omicron BA.2
74% lower combined mortality/ICU admission (p=0.001). Analysis of 1,180 high-risk COVID-19 outpatients infected with Omicron BA.2 showing lower risk of death or ICU admission with sotrovimab treatment.
Nov 30
2023
 Uraki et al., iScience, doi:10.1016/j.isci.2023.108147 Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate
In vitro and animal study showing that the SARS-CoV-2 omicron subvariant XBB.1.9.1 has similar antigenicity, antiviral susceptibility, and replicative ability compared to XBB.1.5. Casirivimab, imdevimab, tixagevimab, cilgavimab, sotrovima..
Nov 27
2023
 Bell et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofad500.579 Real-world Effectiveness of Sotrovimab for COVID-19: Evidence from United States (US) Administrative Claims Data
80% lower mortality (p<0.0001), 30% lower ICU admission (p=0.0002), and 16% lower hospitalization (p<0.0001). Retrospective 34,160 COVID-19 patients in the USA treated with sotrovimab matched to 68,320 untreated patients from May 2021-April 2022, during periods when Delta and early Omicron were predominant. Sotrovimab-treated patients had signifi..
Nov 23
2023
 Leducq et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiad523 Spike protein genetic evolution in patients at high-risk of severe COVID-19 treated by monoclonal antibodies
Prospective study of 264 high-risk COVID-19 patients treated with monoclonal antibodies. Tixagevimab/cilgavimab was associated with 5 times higher risk of emergence of mutations. Treatment with sotrovimab was linked to mutations associate..
Sep 28
2023
 Pochtovyi et al., Vaccines, doi:10.3390/vaccines11101533 In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1
In vitro study showing sharply reduced neutralization of SARS-CoV-2 variants XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1 with monoclonal antibodies cilgavimab, tixagevimab, imdevimab, etsevimab, casirivim..
Sep 27
2023
 Haars et al., Microorganisms, doi:10.3390/microorganisms11102417 Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023
Analysis of 7,950 SARS-CoV-2 samples from central Sweden collected between March 2022 and May 2023 tracking the prevalence of omicron sublineages and mutations in the spike protein conferring resistance to monoclonal antibodies over time...
Aug 17
2023
 De Vito et al., Viruses, doi:10.3390/v15081757 What Is the Efficacy of Sotrovimab in Reducing Disease Progression and Death in People with COVID-19 during the Omicron Era? Answers from a Real-Life Study
81% lower mortality (p=0.0005) and 92% lower need for oxygen therapy (p<0.0001). Retrospective 689 COVID-19 patients in Italy, showing lower mortality with sotrovimab treatment.
Aug 10
2023
 Focosi et al., Drug Resistance Updates, doi:10.1016/j.drup.2023.100991 Analysis of SARS-CoV-2 mutations associated with resistance to therapeutic monoclonal antibodies that emerge after treatment
Review of reports of treatment-emergent resistance to COVID-19 monoclonal antibodies (mAbs), showing that some post-mAb treatment mutations appeared to spread globally soon after the mAb was introduced, raising concerns about transmission..
Jul 27
2023
 Drysdale et al., BMJ Open Respiratory Research, doi:10.1136/bmjresp-2023-002238 Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study
29% lower mortality (p=0.65), 50% lower combined mortality/hospitalization (p=0.07), and 57% lower hospitalization (p=0.05). Retrospective 599 high-risk sotrovimab patients and 5,191 untreated controls, showing lower hospitalization/mortality with treatment, without statistical significance in the overall cohort. Efficacy was better for those ≥65, and efficacy ..
May 31
2023
 Miyashita et al., Viruses, doi:10.3390/v15061300 Clinical Efficacy of the Neutralizing Antibody Therapy Sotrovimab in Patients with SARS-CoV-2 Omicron BA.1 and BA.2 Subvariant Infections
55% lower need for oxygen therapy (p<0.0001). Retrospective 844 patients treated with sotrovimab and matched controls in Japan, showing lower risk of oxygen therapy with treatment.
May 16
2023
 Tazare et al., medRxiv, doi:10.1101/2023.05.12.23289914 Effectiveness of Sotrovimab and Molnupiravir in community settings in England across the Omicron BA.1 and BA.2 sublineages: emulated target trials using the OpenSAFELY platform
16% lower combined mortality/hospitalization (p=0.002). OpenSAFELY retrospective 75,048 outpatients in the UK, using the clone-censor-weight approach to address immortal time bias, showing lower combined mortality/hospitalization with sotrovimab treatment.
Apr 4
2023
 Kip et al., Annals of Internal Medicine, doi:10.7326/M22-1286 Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19
30% lower combined mortality/hospitalization (p=0.14). Retrospective 2,571 patients treated with mAbs in the USA, and 5,135 control patients, showing lower combined mortality/hospitalization for bamlanivimab, bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, and bebtelovimab, with s..
Mar 24
2023
 Shapiro et al., medRxiv, doi:10.1101/2023.03.21.23287410 Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial
RCT 982 high risk outpatients in the USA reporting that intramuscular sotrovimab was non-inferior to intravenous administration. Death and hospitalization was more frequent with intramuscular administration, without statistical significan..
Mar 15
2023
 Goodwin et al., PLOS ONE, doi:10.1371/journal.pone.0281915 Evaluation of outpatient treatment for non-hospitalised patients with COVID-19: The experience of a regional centre in the UK
75% lower mortality (p=0.55) and 60% lower hospitalization (p=0.35). Retrospective 604 outpatients in the UK, showing lower risk of hospitalization with sotrovimab treatment, without statistical significance due to the small number of hospitalizations.
Jan 25
2023
 Evans et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.012 Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study
27% lower combined mortality/hospitalization (p=0.03). Retrospective high risk outpatients in the UK, showing lower hospitalization/death with sotrovimab treatment. Residual confounding is likely with adjustments having no detail on specific comorbidities.
Jan 22
2023
 Zheng et al., medRxiv, doi:10.1101/2023.01.20.23284849 Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised patients: observational cohort study using the OpenSAFELY platform
4% lower combined mortality/hospitalization (p=0.91). OpenSAFELY retrospective 7,683 outpatients in the UK, showing no significant difference in hospitalization/death between paxlovid and sotrovimab.
Dec 8
2022
 Woo et al., Microbiology Spectrum, doi:10.1128/spectrum.04103-22 Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study
140% higher mortality (p=0.12). PSM retrospective 1,254 hospitalized patients in Germany, 147 treated with sotrovimab, showing higher mortality with sotrovimab, without statistical significance.
Nov 16
2022
 Zheng et al., BMJ, doi:10.1136/bmj-2022-071932 Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform
50% lower combined mortality/hospitalization (p=0.005). Retrospective 3,331 sotrovimab and 2,689 molnupiravir patients in the UK, showing lower risk of combined hospitalization/death with sotrovimab.
Oct 7
2022
 Mazzotta et al., Journal of Medical Virology, doi:10.1002/jmv.28186 Viral load decrease in SARS‐CoV‐2 BA.1 and BA.2 Omicron sublineages infection after treatment with monoclonal antibodies and direct antiviral agents
Observational study of 521 outpatients with mild-to-moderate COVID-19 showing paxlovid had stronger viral load reduction against Omicron BA.1 and BA.2 variants compared to sotrovimab, molnupiravir, and remdesivir, with the exception of co..
Oct 6
2022
 Brown et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac527 Demographics and outcomes of initial phase of COVID-19 Medicines Delivery Units across 4 UK centres during peak B1.1.529 omicron epidemic: a service evaluation
258% higher hospitalization (p=0.15). Retrospective 186 patients in the UK treated with sotrovimab, and 222 eligible but declining treatment, showing no significant difference in hospitalization. No group details are provided and the results are subject to confounding by indi..
Oct 5
2022
 Suzuki et al., Research Square, doi:10.21203/rs.3.rs-2118653/v1 Real-world clinical outcomes of treatment with molnupiravir for patients with mild- to-moderate coronavirus disease 2019 during the Omicron variant pandemic
8% higher progression (p=0.73). Retrospective 1,921 patients in Japan, showing no significant difference in progression with sotrovimab use.
Oct 3
2022
 Gliga et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac802 Rapid Selection of Sotrovimab Escape Variants in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron-Infected Immunocompromised Patients
Prospective analysis of 57 COVID-19 patients receiving sotrovimab, showing rapid creation of escape mutations within immunodeficient patients. Combined treatment with remdesivir reduced the creation of escape variants.
Sep 16
2022
 Shimizu et al., Scientific Reports, doi:10.1038/s41598-022-19993-w Reevaluation of antibody-dependent enhancement of infection in anti-SARS-CoV-2 therapeutic antibodies and mRNA-vaccine antisera using FcR- and ACE2-positive cells
In vitro study showing no antibody-dependent enhancement (ADE) with sotrovimab. ADE was seen for casirivimab/imdevimab within a specific concentration range.
Sep 11
2022
 Cheng et al., medRxiv, doi:10.1101/2022.09.07.22279497 Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the United States
88% lower mortality (p<0.0001) and 61% lower hospitalization (p<0.0001). Retrospective 1,530,501 high-risk patients in the USA, 15,633 treated with sotrovimab, showing significantly lower mortality and hospitalization with treatment. Sotrovimab maintained efficacy throughout the period analyzed - September 202..
Sep 9
2022
 Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8 Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
20% higher severe cases (p=0.79). Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early sotrovimab use.
Aug 1
2022
 Piccicacco et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac256 Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 outpatients during the Omicron surge
35% lower hospitalization (p=0.46), 66% fewer combined hospitalization/ER visits (p=0.01), and 90% lower progression (p=0.009). Retrospective high-risk outpatients in the USA, 82 treated with remdesivir, 88 with sotrovimab, and 90 control patients, showing significantly lower combined hospitalization/ER visits with both treatments in unadjusted results. The domina..
Jul 28
2022
 Villanego et al., Clinical Kidney Journal, doi:10.1093/ckj/sfac177 Treatment with sotrovimab for SARS-CoV-2 infection in a cohort of high-risk kidney transplant recipients
Retrospective 82 kidney transplant recipients treated with sotrovimab, showing lower risk of serious COVID-19 outcomes with early treatment.
Jun 18
2022
 Aggarwal et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.10.002 (date from preprint) Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality for At-risk COVID-19 Outpatients During an Omicron BA.1 and BA.1.1-Predominant Phase
38% lower mortality (p=0.62), 18% lower hospitalization (p=0.32), and 3% higher progression (p=0.83). Retrospective 30,247 outpatients in the USA, showing no significant differences with sotrovimab with omicron BA.1.
May 3
2022
 Gleeson et al., medRxiv, doi:10.1101/2022.05.03.22274524 Kidney Transplant Recipients and Omicron: Outcomes, effect of vaccines and the efficacy and safety of novel treatments
90% lower hospitalization (p=0.008). Retrospective 116 kidney transplant recipients diagnosed with COVID-19 in the community during the Omicron era in the UK, showing lower hospitalization with sotrovimab, but no significant difference with molnupiravir. Two molnupiravir-tre..
Apr 21
2022
 Zaqout et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.09.023 (date from preprint) Effectiveness of the neutralizing antibody sotrovimab among high-risk patients with mild-to-moderate SARS-CoV-2 in Qatar
165% higher progression (p=0.19). Retrospective 345 sotrovimab treated patients in Qatar matched with 583 patients that opted not to receive treatment, showing higher progression with treatment, without statistical significance.
Apr 5
2022
 FDA Update, 4/5 FDA updates Sotrovimab emergency use authorization
FDA has revoked sotrovimab's authorization in all regions due to predicted low efficacy with BA.2, and BA.2 exceeding 50% prevalence in all regions.
Apr 5
2022
 Aggarwal et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiac206 (date from preprint) Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients
89% lower mortality (p=0.02), 62% lower hospitalization (p=0.002), and 11% higher progression (p=0.55). PSM retrospective 10,036 outpatients, 522 treated with sotrovimab, showing lower mortality and hospitalization with treatment.
Mar 5
2022
 Ong et al., Antibiotics, doi:10.3390/antibiotics11030345 Real-World Use of Sotrovimab for Pre-Emptive Treatment in High-Risk Hospitalized COVID-19 Patients: An Observational Cross-Sectional Study
56% lower ICU admission (p=0.35) and 59% lower progression (p=0.05). Retrospective 19 sotrovimab patients and 75 controls is Singapore, showing lower progression with treatment.
Feb 16
2022
 Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies
In vitro study showing that omicron BA.2 evades all monoclonal antibodies tested, including sotrovimab and tixagevimab/cilgavimab which retained activity for omicron BA.1.
Dec 23
2021
 Self et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(21)00751-9 Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
2% higher mortality (p=0.96) and 11% improved recovery (p=0.29). RCT with 182 sotrovimab patients, 176 BRII-196+BRII-198 patients, and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility. Long-term results are reported in [Mou..
Dec 21
2021
 Rockett et al., medRxiv, doi:10.1101/2021.12.18.21267628 Resistance conferring mutations in SARS-CoV-2 delta following sotrovimab infusion
Retrospective 100 sotrovimab patients in Australia, 23 PCR+ more than 10 days post-infusion (68 with status unknown), showing rapid development of spike gene mutations that have been shown to confer high level resistance to sotrovimab in ..
Dec 20
2021
 Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron)
In vitro study showing that omicron is substantially resistant to neutralization by monoclonal antibodies REGN10933, REGN10987, Ly-CoV016 and Ly-CoV555. S309 (the parent of Sotrovimab) had only 2-fold loss in potency.
Dec 17
2021
 VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies
In vitro study (Vero-TMPRSS2 and Vero-hACE2-TMPRSS2) showing complete loss of inhibitory activity for B.1.1.529 omicron with LY-CoV555, LY-CoV016, REGN10933, REGN10987, and CT-P59, ~12-fold decrease for COV2-2196/COV2-2130, and minimal ch..
Dec 15
2021
 Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2
In vitro study (Vero-E6-TMPRSS2) showing 18 of 19 monoclonal antibodies were no longer effective or significantly impaired with B.1.1.529 omicron.
Dec 4
2021
 Gupta et al., JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21) Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19
89% lower ventilation (p=0.12), 75% lower progression (p=0.0004), and 79% lower combined mortality/hospitalization (p=0.0004). RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization >24h or mortality with treatment.
May 26
2021
 Gupta et al., NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021) Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
91% lower ICU admission (p=0.06) and 81% lower hospitalization (p=0.0007). Interim results from the COMET-ICE trial showing significantly lower hospitalization with treatment. NCT04545060.
References