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Bamlanivimab COVID-19 studies. Efficacy is highly variant dependent. In Vitro studies suggest a lack of efficacy for omicron. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape. Recently added: Choudhary Ganesh Chew. Bamlanivimab has been officially adopted for early treatment in 2 countries. Submit updates/corrections.
 
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Jan 13
Early, Late, PrEP, PEP Covid Analysis (Preprint) (meta analysis)
meta-analysis
Bamlanivimab for COVID-19: real-time meta analysis of 11 studies
Details   • Statistically significant improvements are seen for mortality, ICU admission, hospitalization, and viral clearance. 10 studies from 7 independent teams (all from the same country) show statistically significant improvements in isolation..
Dec 21
Late Chew et al., medRxiv, doi:10.1101/2021.12.17.21268009 (Preprint)
hosp., ↓25.5%, p=0.60
Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19
Details   RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes. ACTIV-2/A5401. NCT04518410. Supplementary data is not currently available.
Dec 20
In Vitro Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 (Preprint) (In Vitro)
In Vitro
Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron)
Details   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
In Vitro VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 (Preprint) (In Vitro)
In Vitro
An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies
Details   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
In Vitro Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 (Preprint) (In Vitro)
In Vitro
Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2
Details   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.
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..
Oct 1
Late Ganesh et al., Journal of Clinical Investigation, doi:10.1172/JCI151697 (Peer Reviewed)
death, ↓74.4%, p=0.11
Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19
Details   Retrospective 2,335 bamlanivimab patients and 2,335 PSM controls in the USA, showing significantly lower hospitalization with treatment.
Sep 15
Late Choudhary et al., medRxiv, doi:10.1101/2021.09.03.21263105 (Preprint) Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy
Details   Analysis of ACTIV-2/A5401, showing the potential for rapid emergence of resistance during monoclonal antibody treatment, resulting in prolonged high level viral loads and clinical worsening. Treatment-emergent resistance mutations were mo..
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 incorrectly state that "no other COVID-19 therapies for ambulatory patients hav..
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=0.046
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=0.049
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 ..
Please send us corrections, updates, or comments. Vaccines and treatments are both valuable and complementary. All practical, effective, and safe means should be used. Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases mortality, morbidity, collateral damage, and the risk of endemic status. 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. WCH and FLCCC provide treatment protocols.
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