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c19early.org COVID-19 treatment researchSotrovimabSotrovimab (more..)
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Sotrovimab for COVID-19
22 studies from 441 scientists
43,988 patients in 8 countries
Statistically significant lower risk for hospitalization.
12 studies from 12 independent teams in 6 countries show statistically significant improvements.
Efficacy is variant dependent.
COVID-19 Sotrovimab studies. Apr 2024. c19early.org
0 0.5 1 1.5+ All studies 29% With exclusions 32% Mortality 49% Hospitalization 32% RCTs 10% RCT mortality 10% Early 33% Late -40% Favorssotrovimab Favorscontrol
Efficacy is variant dependent. In Vitro studies suggest lower efficacy for omicron BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.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, Günther, Leducq. Recent:
Bell
Wilcock.
Sotrovimab was adopted in 37 countries. Submit updates/corrections.
Apr 17
Covid Analysis Sotrovimab for COVID-19: real-time meta analysis of 22 studies
Statistically significant lower risk is seen for hospitalization. 12 studies from 12 independent teams in 6 countries show statistically significant improvements. Meta analysis using the most serious outcome reported shows 29% [12..
Feb 20
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
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 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 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.
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 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=0.05), 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
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 and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility.
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.
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