Summary of COVID-19 sotrovimab studies

1,057 patient sotrovimab early treatment RCT: 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.
Dec 2021, JAMA, https://jamanetwork.com/journals/jama/fullarticle/2790246, https://c19p.org/gupta4

2. De Vito et al., 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

689 patient sotrovimab early treatment 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 2023, Viruses, https://www.mdpi.com/1999-4915/15/8/1757, https://c19p.org/devito

3. Aggarwal et al., Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients

10,036 patient sotrovimab early treatment PSM study: 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.
Apr 2022, The J. Infectious Diseases, https://academic.oup.com/jid/article/226/12/2129/6586521, https://c19p.org/aggarwal

4. Piccicacco et al., Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 outpatients during the Omicron surge

178 patient sotrovimab early treatment study: 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 dominant variant was omicron B.1.1.529.
Jul 2022, J. Antimicrobial Chemotherapy, https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkac256/6652940, https://c19p.org/piccicacco

5. Behzad et al., Real world Effectiveness of Sotrovimab in Preventing COVID-19–related Hospitalisation or Death in Patients Infected with Omicron BA.2

1,180 patient sotrovimab early treatment study: 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.
Dec 2023, J. Infection and Public Health, https://www.sciencedirect.com/science/article/pii/S1876034123004355, https://c19p.org/behzad

6. Bell et al., 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

35,485 patient sotrovimab early treatment PSM study: 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.
Jul 2024, PLOS ONE, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0304822, https://c19p.org/bell4

7. Maria et al., Does early combination vs. Monotherapy improve clinical outcomes of clinically extremely vulnerable patients with COVID-19? Results from a retrospective propensity-weighted analysis

81 patient sotrovimab early treatment study: 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 compared to antiviral monotherapy.
Oct 2024, European J. Medical Research, https://eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02062-5, https://c19p.org/maria

8. Bell et al., Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the US National COVID Cohort Collaborative (N3C)

546,317 patient sotrovimab early treatment study: 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 variant predominance in the US (September 2021-April 2022).
Feb 2024, Clinical Drug Investigation, https://link.springer.com/10.1007/s40261-024-01344-4, https://c19p.org/bell3

9. Ong et al., Real-World Use of Sotrovimab for Pre-Emptive Treatment in High-Risk Hospitalized COVID-19 Patients: An Observational Cross-Sectional Study

94 patient sotrovimab early treatment 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.
Mar 2022, Antibiotics, https://www.mdpi.com/2079-6382/11/3/345, https://c19p.org/ong2

10. Miyashita et al., Clinical Efficacy of the Neutralizing Antibody Therapy Sotrovimab in Patients with SARS-CoV-2 Omicron BA.1 and BA.2 Subvariant Infections

1,688 patient sotrovimab early treatment study: 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 2023, Viruses, https://www.mdpi.com/1999-4915/15/6/1300, https://c19p.org/miyashita2

11. Drysdale et al., Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study

5,790 patient sotrovimab early treatment 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 was lower in later time periods.
Jul 2023, BMJ Open Respiratory Research, https://bmjopenrespres.bmj.com/lookup/doi/10.1136/bmjresp-2023-002238, https://c19p.org/drysdale

12. Goodwin et al., Evaluation of outpatient treatment for non-hospitalised patients with COVID-19: The experience of a regional centre in the UK

505 patient sotrovimab early treatment study: 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.
Mar 2023, PLOS ONE, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0281915, https://c19p.org/goodwin

13. Evans et al., 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

6,052 patient sotrovimab early treatment 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 2023, J. Infection, https://www.sciencedirect.com/science/article/pii/S0163445323000828, https://c19p.org/evans2v

14. Zheng et al., 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

6,020 patient sotrovimab early treatment study: 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.
Nov 2022, BMJ, https://www.bmj.com/lookup/doi/10.1136/bmj-2022-071932, https://c19p.org/zheng4v

15. Tazare et al., 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

71,976 patient sotrovimab early treatment study: 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.
May 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.05.12.23289914, https://c19p.org/tazarev

16. Aggarwal et al., 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

30,247 patient sotrovimab early treatment study: 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.
Jun 2022, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971222005409, https://c19p.org/aggarwal2

17. Kip et al., Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19

2,571 patient sotrovimab early treatment study: 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 statistical significance only for casirivimab/imdevimab.
Apr 2023, Annals of Internal Medicine, https://www.acpjournals.org/doi/10.7326/M22-1286, https://c19p.org/kipv

18. Zheng et al., 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

7,683 patient sotrovimab early treatment study: 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.
Jan 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.01.20.23284849, https://c19p.org/zheng5v

19. Suzuki et al., Real-world clinical outcomes of treatment with molnupiravir for patients with mild- to-moderate coronavirus disease 2019 during the Omicron variant pandemic

1,929 patient sotrovimab early treatment study: 8% higher progression (p=0.73).
Retrospective 1,921 patients in Japan, showing no significant difference in progression with sotrovimab use.
Oct 2022, Research Square, https://www.researchsquare.com/article/rs-2118653/v1, https://c19p.org/suzuki2v

20. Farmer et al., 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

22,289 patient sotrovimab early treatment PSM study: 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 comorbidities, sotrovimab was associated with lower odds of severe outcomes. The study period included Omicron BA.1 and BA.2 variants, which may have contributed to the reduced efficacy compared to earlier studies.
Jun 2024, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971224002078, https://c19p.org/farmer

21. Kneidinger et al., Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study

218 patient sotrovimab early treatment 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.
Sep 2022, Infection, https://link.springer.com/10.1007/s15010-022-01914-8, https://c19p.org/kneidingerv

22. Brown et al., 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

408 patient sotrovimab early treatment study: 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 indication.
Oct 2022, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofac527/6750023, https://c19p.org/brown2v

23. Self et al., 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

360 patient sotrovimab late treatment RCT: 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.
Dec 2021, The Lancet Infectious Diseases, https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00751-9/fulltext, https://c19p.org/self3

24. Woo et al., Sotrovimab in Hospitalized Patients with SARS-CoV-2 Omicron Variant Infection: a Propensity Score-Matched Retrospective Cohort Study

420 patient sotrovimab late treatment PSM 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.
Dec 2022, Microbiology Spectrum, https://journals.asm.org/doi/10.1128/spectrum.04103-22, https://c19p.org/woo

25. Zaqout et al., Effectiveness of the neutralizing antibody sotrovimab among high-risk patients with mild-to-moderate SARS-CoV-2 in Qatar

928 patient sotrovimab early treatment study: 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 2022, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971222005227, https://c19p.org/zaqout

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