Efficacy is variant dependent. In Vitro studies suggest lower efficacy for omicron BA.1 Liu, Sheward, VanBlargan and no efficacy for omicron BA.2 Zhou. US EUA has been revoked. mAb use may create new variants that spread globally Focosi, Leducq, and may be associated with prolonged viral loads, clinical deterioration, and immune escape Choudhary, Leducq.
Recent:Bell Leducq De Vito.
Sotrovimab has been officially adopted
in 36 countries.
Submit updates/corrections .
Dec 2 |
Sotrovimab for COVID-19: real-time meta analysis of 21 studies | |
| Meta analysis using the most serious outcome reported shows 26% [9‑40%] lower risk. Results are similar for higher quality and peer-reviewed studies and worse for Randomized Controlled Trials. Early treatment shows efficacy w.. | ||
Nov 27 |
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 |
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.. | ||
Aug 17 |
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 |
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 |
et al., medRxiv, doi:10.1101/2023.07.26.23293188 | Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk patients with COVID-19 in North West London: a retrospective cohort study using the Discover dataset |
| 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 .. | ||
Jun 12 |
et al., Value in Health, doi:10.1016/j.jval.2023.03.176 | Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the National COVID Cohort Collaborative (N3C) |
| 25% lower combined mortality/hospitalization (p=0.004). N3C IPTW retrospective 4,992 COVID-19 patients in the USA treated with sotrovimab and 541,325 controls, showing lower combined hospitalization or mortality. | ||
May 31 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 6 2022 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. | ||
Apr 21 2022 |
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 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 |
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=0.05), 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 |
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 |
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 |
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 and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility. | ||
Dec 21 2021 |
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 |
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 |
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 |
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 |
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 |
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. | ||
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