Summary of COVID-19 bamlanivimab/etesevimab studies

1,035 patient bamlanivimab/etesevimab early treatment RCT: 95% lower mortality (p=0.002), 70% lower combined mortality/hospitalization (p=0.0002), 11% faster recovery (p=0.007), and 67% improved viral clearance (p<0.0001).
Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. NCT04427501.
Oct 2021, New England J. Medicine, https://www.nejm.org/doi/10.1056/NEJMoa2102685, https://c19p.org/dougan

2. Gottlieb et al., Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19

153 patient bamlanivimab/etesevimab early treatment RCT: 71% fewer combined hospitalization/ER visits (p=0.05).
RCT for LY-CoV555 monotherapy and LY-CoV555/LY-CoV016 combination therapy with 592 patients showing lower hospitalization/ER visits with treatment. For viral load at day 11, a statistically significant reduction was found with combination therapy but not monotherapy.
Jan 2021, JAMA, https://jamanetwork.com/journals/jama/fullarticle/2775647, https://c19p.org/gottlieb

3. Dale et al., Clinical Outcomes of Monoclonal Antibody Therapy During a COVID-19 Outbreak in a Skilled Nursing Facility - Arizona, 2021

75 patient bamlanivimab/etesevimab early treatment study: 89% lower mortality (p=0.01) and 86% lower progression (p=0.002).
Retrospective 75 COVID+ patients in a skilled nursing facility in the USA, 56 treated within a median of 2 days from symptom onset with bamlanivimab, showing significantly lower mortality with treatment.
Feb 2022, J. the American Geriatrics Society, https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/jgs.17705, https://c19p.org/dale

4. Lilly et al., Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents

965 patient bamlanivimab/etesevimab prophylaxis RCT: 57% fewer symptomatic cases (p=0.0002).
Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
Jan 2021, Lilly, Press Release, https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented, https://c19p.org/lilly3

5. Alam et al., Clinical Impact of the Early Use of Monoclonal Antibody LY-CoV555 (Bamlanivimab) on Mortality and Hospitalization Among Elderly Nursing Home Patients: A Multicenter Retrospective Study

246 patient bamlanivimab/etesevimab early treatment study: 75% lower mortality (p=0.03) and 65% lower hospitalization (p=0.08).
Retrospective 246 nursing home patients showing lower mortality with early bamlanivimab treatment.
May 2021, Cureus, https://www.cureus.com/articles/58640-clinical-impact-of-the-early-use-of-monoclonal-antibody-ly-cov555-bamlanivimab-on-mortality-and-hospitalization-among-elderly-nursing-home-patients-a-multicenter-retrospective-study, https://c19p.org/alam5

6. Webb et al., Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19

6,015 patient bamlanivimab/etesevimab early treatment study: 80% lower mortality (p=0.09), 53% lower hospitalization (p<0.0001), and 27% fewer combined hospitalization/ER visits (p<0.0001).
Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors incorrectly state that "no other COVID-19 therapies for ambulatory patients have proven effective".
Jun 2021, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab331/6308074, https://c19p.org/webb

7. Bariola et al., Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection

468 patient bamlanivimab/etesevimab late treatment study: 67% lower mortality (p=0.05), 64% lower combined mortality/hospitalization (p=0.0003), and 61% lower hospitalization (p=0.001).
Retrospective 234 patients receiving bamlanivimab and 234 matched controls, showing lower hospitalization and mortality with treatment. Greater benefit was seen with administration within 4 days of their positive COVID-19 test.
Mar 2021, medRxiv, https://www.medrxiv.org/content/10.1101/2021.03.25.21254322v1, https://c19p.org/bariola

8. Ganesh et al., Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19

3,621 patient bamlanivimab/etesevimab late treatment study: 74% lower mortality (p=0.11), 49% lower ICU admission (p=0.1), and 37% lower hospitalization (p=0.01).
Retrospective 2,335 bamlanivimab patients and 2,335 PSM controls in the USA, showing significantly lower hospitalization with treatment.
Sep 2021, J. Clinical Investigation, https://www.jci.org/articles/view/151697, https://c19p.org/ganesh

9. Corwin et al., The Efficacy of Bamlanivimab in Reducing Emergency Department Visits and Hospitalizations in a Real-world Setting

6,117 patient bamlanivimab/etesevimab early treatment study: 80% lower mortality (p=0.08) and 39% lower hospitalization (p=0.0004).
Retrospective 780 bamlanivimab patients and 5,337 patients not receiving treatment, showing lower hospitalization and ER visits with treatment.
Jun 2021, Open Forum Infectious Diseases, https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofab305/6295837, https://c19p.org/corwin

10. Chew et al., Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19

317 patient bamlanivimab/etesevimab late treatment RCT: 25% lower hospitalization (p=0.6), 14% slower recovery (p=0.97), 1% higher progression (p=1), and 26% improved viral clearance (p=0.002).
RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes.
Aug 2022, Nature Communications, https://www.nature.com/articles/s41467-022-32551-2, https://c19p.org/chew

11. Leavitt et al., Real World Utilization of Bamlanivimab at a Rural Community Hospital

279 patient bamlanivimab/etesevimab early treatment study: 30% lower hospitalization (p=0.6) and 42% improvement (p=0.04).
Retrospective 136 outpatients showing bamlanivimab reduced emergency department visits at 28 days, but not hospitalizations, compared to a control group prior to authoritzation in patients with mild to moderate COVID-19.
Nov 2021, Cureus, https://www.cureus.com/articles/74418-real-world-utilization-of-bamlanivimab-at-a-rural-community-hospital, https://c19p.org/leavitt

12. Karr et al., Bamlanivimab Use in a Military Treatment Facility

46 patient bamlanivimab/etesevimab early treatment study: 62% fewer combined hospitalization/ER visits (p=0.22).
Retrospective 40 outpatients showing improvement in symptoms and lower risk of hospitalization/ER visits with bamlanivimab, without statistical significance. Different counts for hospitalization are provided in the abstract and text: "Three of 40 (7.5%) patients in the treatment group required inpatient admission" and "In the treatment group, 4 of 40 (10%) patients were hospitalized after infusion."
May 2021, Military Medicine, https://academic.oup.com/milmed/article/187/Special%20Issue_13/e1509/6276449, https://c19p.org/karr

13. Rubin et al., Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process

1,257 patient bamlanivimab/etesevimab early treatment study: 65% lower hospitalization (p=0.04).
Retrospective database analysis of 1257 PCR+ outpatients with age ≥65, BMI≥35, 191 receiving bamlanivimab via lottery. Authors note that the alpha variant was most common during the study period, and that efficacy against other variants can be much lower. Authors note confounding due to prioritization in the lottery and differential reporting in the database.
Nov 2021, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab546/6420437, https://c19p.org/rubin

14. Wilden et al., Real World Outcomes of Cancer Patients With SARS-CoV-2 Infection Receiving Monoclonal Antibodies

bamlanivimab/etesevimab early treatment study: 51% lower hospitalization (p=0.06).
Retrospective 395 patients in the USA receiving casirivimab/imdevimab or bamlanivimab, showing lower risk of hospitalization with treatment, statistically significant for casirivimab/imdevimab.
Mar 2022, J. the National Comprehensive Cancer Network, https://jnccn.org/view/journals/jnccn/20/3.5/article-pHSR22-178.xml, https://c19p.org/wildenl

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

2,571 patient bamlanivimab/etesevimab early treatment study: 15% lower combined mortality/hospitalization (p=0.54).
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/kipl

16. Fivelstad et al., Bamlanivimab as monotherapy for high-risk COVID-19 patients with mild to moderate symptoms

483 patient bamlanivimab/etesevimab early treatment study: 63% lower hospitalization (p=0.0006).
Retrospective 335 outpatients with mild to moderate COVID-19 and at least one high-risk comorbidity, showing significantly lower hospitalization with bamlanivimab treatment compared to the control group.
Jul 2022, Int. J. Scientific Research, https://www.researchgate.net/publication/362828024_BAMLANIVIMAB_AS_MONOTHERAPY_FOR_HIGH-RISK_COVID-19_PATIENTS_WITH_MILD_TO_MODERATE_SYMPTOMS, https://c19p.org/fivelstad

17. Cooper et al., Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study

11,434 patient bamlanivimab/etesevimab early treatment study: 7% higher mortality (p=0.86), 17% lower ICU admission (p=0.51), and 24% lower hospitalization (p=0.0005).
Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with monoclonal antibody treatment (bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab). There was significantly lower hospitalization with casirivimab/imdevimab compared to bamlanivimab or bamlanivimab/etesevimab. PSM and multivariate analysis is only provided for all treatments combined.
Oct 2021, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab512/6384727, https://c19p.org/cooper

18. Delasobera et al., Impact of Rapidly Deployed COVID-19 Monoclonal Antibody Infusion Clinics on Rate of Hospitalization

438 patient bamlanivimab/etesevimab early treatment study: 52% lower hospitalization (p=0.01) and 20% lower progression (p=0.52).
Retrospective 438 patients in the USA, 253 treated with bamlanivimab, showing significantly lower hospitalization with treatment.
Jan 2022, Infectious Diseases in Clinical Practice, https://journals.lww.com/10.1097/IPC.0000000000001109, https://c19p.org/delasobera

19. Priest et al., Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2–Positive Patients in a Regional Health Care System

758 patient bamlanivimab/etesevimab late treatment PSM study: no change in mortality (p=1), 4% higher hospitalization (p=0.86), and 5% more combined hospitalization/ER visits (p=0.86).
Retrospective 379 bamlanivimab patients and 379 matched controls in the USA, showing no significant differences with treatment.
Jan 2022, Infectious Diseases in Clinical Practice, https://journals.lww.com/10.1097/IPC.0000000000001130, https://c19p.org/priest

20. Dougan et al., Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19

714 patient bamlanivimab/etesevimab early treatment RCT: 12% faster recovery and 9% improved viral clearance (p<0.0001).
RCT showing improved viral clearance with bamlanivimab/etesevimab combined with bebtelovimab. Results refer to the placebo controlled portion of the trial.
Mar 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.03.10.22272100, https://c19p.org/dougan2l

21. ACTIV-3/TICO LY-CoV555 study group et al., A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

314 patient bamlanivimab/etesevimab late treatment RCT: 100% higher mortality (p=0.22).
Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
Dec 2020, ACTIV-3/TICO LY-CoV555 study group, NEJM, https://www.nejm.org/doi/full/10.1056/NEJMoa2033130, https://c19p.org/activ3

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