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0 0.25 0.5 0.75 1 1.25 1.5 1.75 2+ Chen (RCT) 74% 0.26 [0.09-0.75] hosp. 5/309 9/143 Improvement, RR [CI] Treatment Control Gottlieb (RCT) 71% 0.29 [0.09-0.96] hosp./ER 4/101 7/52 Lilly (DB RCT) 92% 0.08 [0.00-1.43] death 0/511 4/258 Webb 80% 0.20 [0.03-1.46] death 1/479 57/5,536 Cooper 45% 0.55 [0.07-3.99] death 1/473 33/8,534 Rubin 97% 0.03 [0.00-0.25] death 1/191 10/1,066 Tau​2 = 0.03; I​2 = 4.1% Early treatment 79% 0.21 [0.11-0.41] 12/2,064 120/15,589 79% improvement ACTIV-3/T.. (RCT) -100% 2.00 [0.69-5.83] death 9/163 5/151 Improvement, RR [CI] Treatment Control Bariola 67% 0.33 [0.10-1.01] death 4/234 12/234 Tau​2 = 1.30; I​2 = 80.7% Late treatment 18% 0.82 [0.14-4.77] 13/397 17/385 18% improvement Lilly (RCT) 57% 0.43 [0.28-0.67] symp. case 483 (n) 482 (n) Improvement, RR [CI] Treatment Control Tau​2 = 0.00; I​2 = 0.0% Prophylaxis 57% 0.43 [0.28-0.67] 0/483 0/482 57% improvement All studies 65% 0.35 [0.19-0.64] 25/2,944 137/16,456 65% improvement 9 bamlanivimab COVID-19 studies c19ly.com Nov 18, 2021 Tau​2 = 0.41; I​2 = 54.7%; Z = 3.36 Effect extraction pre-specified, see appendix Favors bamlanivimab Favors control
Database of all bamlanivimab COVID-19 studies. The US EUA for bamlanivimab as a sole therapy was revoked due to the increase of resistant variants. Bamlanivimab-etesevimab is authorized only in specific locations, based on the distribution of variants. Submit updates/corrections.
 
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Nov 3
Early 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
Details   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..
Nov 2
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
Details   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..
Oct 29
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
Details   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 ..
Oct 8
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
Details   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..
Jun 23
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
Details   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..
May 18
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
Details   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..
Mar 30
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
Details   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 10
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
Details   Results from the BLAZE-1 study of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment.
Jan 21
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
Details   Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
Jan 21
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
Details   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..
Dec 22
2020
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
Details   Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
Oct 28
2020
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
Details   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
Oct 26
2020
News Lilly, Press Release (News)
news
Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial
Details   ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing.
Oct 7
2020
Early Lilly, Press Release (Preprint)
hosp., ↓84.5%, p=0.05
SARS-CoV-2 neutralizing antibody program update
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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