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Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546 (Peer Reviewed) |
death, ↓97.0%, p<0.01 |
Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process |
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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 c.. |
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Early treatment study
Early treatment study
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| Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546 (Peer Reviewed) |
| Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process |
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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. The adjusted mortality result is in the abstract, with no details or mention in the paper, and we note that the change after adjustments is large: RR 0.56 -> OR 0.03.
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risk of death, 97.0% lower, RR 0.03, p < 0.01, treatment 1 of 191 (0.5%), control 10 of 1,066 (0.9%), OR converted to RR.
risk of hospitalization, 65.3% lower, RR 0.35, p = 0.04, treatment 16 of 191 (8.4%), control 121 of 1,065 (11.4%), OR converted to RR, IPTW weighted logistic regression.
Excluded in after exclusion results of meta analysis:
significant unadjusted confounding possible.
Conflicts of interest:
research funding from the drug patent holder, consulting for the pharmaceutical industry.
Rubin et al., 11/3/2021, retrospective, USA, North America, peer-reviewed, 7 authors.
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N/A |
Kaleta et al., Research Square, doi:10.21203/rs.3.rs-995033/v1 (Preprint) |
Antibody escape and global spread of SARS-CoV-2 lineage A.27 |
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Anaysis of antibody escape showing variant A.27 completely escaped neutralization with LY-COV555 and partially with REGN10987. B.1.617.2 escaped these antibodies in a similar manner, suggesting that L452R facilitates the escape. Authors n.. |
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| Kaleta et al., Research Square, doi:10.21203/rs.3.rs-995033/v1 (Preprint) |
| Antibody escape and global spread of SARS-CoV-2 lineage A.27 |
Anaysis of antibody escape showing variant A.27 completely escaped neutralization with LY-COV555 and partially with REGN10987. B.1.617.2 escaped these antibodies in a similar manner, suggesting that L452R facilitates the escape. Authors note that B.1.351 and P.1 escaped LY-COV555 and REGN10933, likely facilitated by the E484K mutation, suggesting that L452R and E484K lead to escape from LY-COV555 and to partial resistance to either REGN10987 or REGN10933, respectively.
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Kaleta et al., 11/2/2021, preprint, 33 authors.
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Early |
Schiaroli et al., Mediterranean Journal of Hematology and Infectious Diseases, doi:10.4084/MJHID.2021.061 (Peer Reviewed) |
Early Treatment with BamlanivimabAlone does not Prevent COVID-19 Hospitalization and Its Post-Acute Sequelae. A Real Experience in Umbria, Italy |
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Retrospective 39 patients treated with bamlanivimab in Italy, showing results far below expectations based on the BLAZE1 trial. Authors note that most patients had the alpha variant which does not have the E484K and L452R mutations known .. |
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Early treatment study
Early treatment study
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| Schiaroli et al., Mediterranean Journal of Hematology and Infectious Diseases, doi:10.4084/MJHID.2021.061 (Peer Reviewed) |
| Early Treatment with BamlanivimabAlone does not Prevent COVID-19 Hospitalization and Its Post-Acute Sequelae. A Real Experience in Umbria, Italy |
Retrospective 39 patients treated with bamlanivimab in Italy, showing results far below expectations based on the BLAZE1 trial. Authors note that most patients had the alpha variant which does not have the E484K and L452R mutations known to lead to resistance.
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Schiaroli et al., 10/29/2021, retrospective, Italy, Europe, peer-reviewed, 7 authors.
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Early |
Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512 (Peer Reviewed) |
death, ↓45.3%, p=1.00 |
Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study |
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Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with bamlanivimab, bamlanivimab-etesevimab, and casirivimab-imdevimab. There was significantly lower hospitalization w.. |
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Early treatment study
Early treatment study
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| Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512 (Peer Reviewed) |
| Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study |
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Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with bamlanivimab, bamlanivimab-etesevimab, and 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.
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risk of death, 45.3% lower, RR 0.55, p = 1.00, treatment 1 of 473 (0.2%), control 33 of 8,534 (0.4%), unadjusted, bamlanivimab-etesevimab.
risk of ICU admission, 57.5% lower, RR 0.42, p = 0.33, treatment 2 of 473 (0.4%), control 85 of 8,534 (1.0%), unadjusted, bamlanivimab-etesevimab.
risk of hospitalization, 5.0% lower, RR 0.95, p = 0.86, treatment 37 of 473 (7.8%), control 703 of 8,534 (8.2%), unadjusted, bamlanivimab-etesevimab.
risk of death, 17.2% higher, RR 1.17, p = 0.59, treatment 11 of 2,427 (0.5%), control 33 of 8,534 (0.4%), unadjusted, bamlanivimab.
risk of ICU admission, 9.0% lower, RR 0.91, p = 0.81, treatment 22 of 2,427 (0.9%), control 85 of 8,534 (1.0%), unadjusted, bamlanivimab.
risk of hospitalization, 28.0% lower, RR 0.72, p < 0.001, treatment 144 of 2,427 (5.9%), control 703 of 8,534 (8.2%), unadjusted, bamlanivimab.
Excluded in after exclusion results of meta analysis:
unadjusted results with no group details.
Cooper et al., 10/8/2021, retrospective, USA, North America, peer-reviewed, 9 authors.
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Early |
Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 (Peer Reviewed) |
death, ↓79.7%, p=0.09 |
Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19 |
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Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors falsely state that "no other COVID-19 therapies for ambulatory patients have pr.. |
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Early treatment study
Early treatment study
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| Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 (Peer Reviewed) |
| Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19 |
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Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors falsely state that "no other COVID-19 therapies for ambulatory patients have proven effective".
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risk of death, 79.7% lower, RR 0.20, p = 0.09, treatment 1 of 479 (0.2%), control 57 of 5,536 (1.0%).
risk of hospitalization, 52.7% lower, RR 0.47, p < 0.001, treatment 22 of 479 (4.6%), control 538 of 5,536 (9.7%).
Webb et al., 6/23/2021, retrospective, USA, North America, peer-reviewed, 14 authors.
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N/A |
Focosi et al., Research Square, doi:10.21203/rs.3.rs-524959/v1 (Preprint) |
Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19 |
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Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, an.. |
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| Focosi et al., Research Square, doi:10.21203/rs.3.rs-524959/v1 (Preprint) |
| Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19 |
Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, and that bamlanivimab was withdrawn as a monotherapy because of failure against E484K-positive SARS-CoV-2 variants.
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Focosi et al., 5/18/2021, preprint, 7 authors.
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Late |
Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint) |
death, ↓66.8%, p=0.05 |
Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection
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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. |
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Late treatment study
Late treatment study
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| Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint) |
| Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection
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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.
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risk of death, 66.8% lower, RR 0.33, p = 0.05, treatment 4 of 234 (1.7%), control 12 of 234 (5.1%), OR converted to RR.
risk of hospitalization, 60.7% lower, RR 0.39, p = 0.001, treatment 15 of 234 (6.4%), control 39 of 234 (16.7%), OR converted to RR.
Bariola et al., 3/30/2021, retrospective, USA, North America, preprint, 22 authors.
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Early |
Lilly, Press Release (Preprint) |
death, ↓92.3%, p=0.01 |
Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19 |
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Results from the BLAZE-1 study of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. |
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Early treatment study
Early treatment study
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| Lilly, Press Release (Preprint) |
| Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19 |
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Results from the BLAZE-1 study of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment.
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risk of death, 92.3% lower, RR 0.08, p = 0.01, treatment 0 of 511 (0.0%), control 4 of 258 (1.6%), relative risk is not 0 because of continuity correction due to zero events.
risk of combined hospitalization/death, 86.5% lower, RR 0.13, p < 0.001, treatment 4 of 511 (0.8%), control 15 of 258 (5.8%).
Lilly et al., 3/10/2021, Double Blind Randomized Controlled Trial, USA, North America, preprint, 1 author.
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PrEPPEP |
Lilly, Press Release (Preprint) |
symp. case, ↓57.0%, p=0.0002 |
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 |
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Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment. |
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Prophylaxis study
Prophylaxis study
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| Lilly, Press Release (Preprint) |
| 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 |
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Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
risk of symptomatic case, 57.0% lower, RR 0.43, p < 0.001, treatment 483, control 482, group sizes estimated because they were not supplied.
risk of symptomatic case, 80.0% lower, RR 0.20, p < 0.001, treatment 150, control 149, nursing home residents, group sizes estimated because they were not supplied.
Lilly et al., 1/21/2021, Randomized Controlled Trial, USA, North America, preprint, 1 author.
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Early |
Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 (Peer Reviewed) |
hosp./ER, ↓70.6%, p=0.05 |
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 |
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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 combinatio.. |
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Early treatment study
Early treatment study
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| Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 (Peer Reviewed) |
| Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 |
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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.
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risk of hospitalization/ER, 70.6% lower, RR 0.29, p = 0.05, treatment 4 of 101 (4.0%), control 7 of 52 (13.5%), LY-CoV555 all dosages.
risk of hospitalization/ER, 79.9% lower, RR 0.20, p = 0.13, treatment 1 of 37 (2.7%), control 7 of 52 (13.5%), LY-CoV555 700mg.
risk of hospitalization/ER, 75.2% lower, RR 0.25, p = 0.25, treatment 1 of 30 (3.3%), control 7 of 52 (13.5%), LY-CoV555 2800mg.
risk of hospitalization/ER, 56.3% lower, RR 0.44, p = 0.31, treatment 2 of 34 (5.9%), control 7 of 52 (13.5%), LY-CoV555 7000mg.
risk of hospitalization/ER, 91.8% lower, RR 0.08, p = 0.04, treatment 0 of 31 (0.0%), control 7 of 52 (13.5%), relative risk is not 0 because of continuity correction due to zero events, LY-CoV555/LY-CoV016.
Gottlieb et al., 1/21/2021, Randomized Controlled Trial, USA, North America, peer-reviewed, 27 authors.
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Late |
ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 (Peer Reviewed) |
death, ↑100%, p=0.22 |
A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 |
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Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555. |
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Late treatment study
Late treatment study
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| ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 (Peer Reviewed) |
| A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 |
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Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
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risk of death, 100% higher, RR 2.00, p = 0.22, treatment 9 of 163 (5.5%), control 5 of 151 (3.3%), adjusted, proportional hazards regression.
ACTIV-3/TICO et al., 12/22/2020, Randomized Controlled Trial, USA, North America, peer-reviewed, 1 author.
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Early |
Chen et al., NEJM, doi:10.1056/NEJMoa2029849 (Peer Reviewed) |
hosp., ↓74.3%, p=0.02 |
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 |
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Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo.
NCT04427501 |
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Early treatment study
Early treatment study
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| Chen et al., NEJM, doi:10.1056/NEJMoa2029849 (Peer Reviewed) |
| SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 |
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Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo.NCT04427501
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risk of hospitalization, 74.3% lower, RR 0.26, p = 0.02, treatment 5 of 309 (1.6%), control 9 of 143 (6.3%).
Chen et al., 10/28/2020, Randomized Controlled Trial, USA, North America, peer-reviewed, 12 authors.
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News |
Lilly, Press Release (News) |
news |
Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial |
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ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing. |
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News
News
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| Lilly, Press Release (News) |
| Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial |
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ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing.
Lilly et al., 10/26/2020, preprint, 1 author.
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Early |
Lilly, Press Release (Preprint) |
hosp., ↓84.5%, p=0.05 |
SARS-CoV-2 neutralizing antibody program update |
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Details
Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization.
Combination therapy significantly reduced viral load at day 11 (p=0.011). A greater effect is seen at day 7 (p<0.001). The .. |
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Early treatment study
Early treatment study
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| Lilly, Press Release (Preprint) |
| SARS-CoV-2 neutralizing antibody program update |
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Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization.Combination therapy significantly reduced viral load at day 11 (p=0.011). A greater effect is seen at day 7 (p<0.001). The proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent), corresponding to a nominal p value of p<0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent (p=0.049). This was also similar to observations for LY-CoV555 monotherapy.Combination therapy has been generally well tolerated with no drug-related serious adverse events. In LY-CoV555 monotherapy studies there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, all patients recovered).NCT04427501
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risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.05, treatment 112, control 156.
Lilly et al., 10/7/2020, Randomized Controlled Trial, USA, North America, preprint, 1 author.
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