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Sotrovimab for COVID-19
15 studies from 933 scientists
32,637 patients in 6 countries
7 studies from 7 independent teams in 3 countries show statistically significant improvements in isolation.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 and a lack of efficacy for BA.2. US EUA has been revoked.
COVID-19 Sotrovimab studies. Feb 2023. c19early.org/v
0 0.5 1 1.5+ All studies 24% With exclusions 32% Mortality 56% Hospitalization 39% RCTs 10% RCT mortality 10% Early 33% Late -40% Favorssotrovimab Favorscontrol
Sotrovimab COVID-19 studies. 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 US EUA has been revoked. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. Recent:
Evans
Zheng
Shimizu
Gliga
Woo
Zheng
Suzuki.
Sotrovimab has been officially adopted for early treatment in 10 countries. Submit updates/corrections.
Feb 1
Covid Analysis (Preprint) (meta analysis) Sotrovimab for COVID-19: real-time meta analysis of 15 studies
Meta analysis using the most serious outcome reported shows 24% [-20‑52%] improvement, without reaching statistical significance. Results are worse for Randomized Controlled Trials, similar after exclusions, and worse for pee..
Jan 25
Evans et al., medRxiv, doi:10.1101/2023.01.24.23284916 (Preprint) 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
Zheng et al., medRxiv, doi:10.1101/2023.01.20.23284849 (Preprint) 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
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
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
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
Suzuki et al., Research Square, doi:10.21203/rs.3.rs-2118653/v1 (Preprint) 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
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
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
Cheng et al., medRxiv, doi:10.1101/2022.09.07.22279497 (Preprint) 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
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
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
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
Aggarwal et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.10.002 (date from earlier 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
Zaqout et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.09.023 (date from earlier 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
FDA (News) 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
Aggarwal et al., medRxiv, doi:10.1101/2022.04.03.22273360 (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] and 62% lower hospitalization [p=0.002]. Retrospective 522 sotrovimab patients and matched controls in the USA, showing significantly lower hospitalization and mortality with treatment.
Mar 5
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
Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 (Preprint) (In Vitro) 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 (Preprint) 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 (Preprint) (In Vitro) 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 (Preprint) (In Vitro) 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 (Preprint) (In Vitro) 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) (Preprint) 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.
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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