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Bamlanivimab/etesevimab COVID-19 studies. Efficacy is highly variant dependent. In Vitro studies suggest a lack of efficacy for omicron [Liu, Sheward, VanBlargan]. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. Bamlanivimab/etesevimab has been officially adopted for early treatment in 3 countries. Submit updates/corrections.
Aug 12
Early, Late, PrEP, PEP Covid Analysis (Preprint) (meta analysis)
meta-analysis
Bamlanivimab/etesevimab for COVID-19: real-time meta analysis of 14 studies
Details   • Statistically significant improvements are seen for mortality, ICU admission, hospitalization, recovery, and cases. 11 studies from 9 independent teams (all from the same country) show statistically significant improvements in isolation..
Mar 31
Early Wilden et al., Journal of the National Comprehensive Cancer Network, doi:10.6004/jnccn.2021.7309
hosp., ↓51.0%, p=0.06
Real World Outcomes of Cancer Patients With SARS-CoV-2 Infection Receiving Monoclonal Antibodies
Details   Retrospective 395 patients in the USA receiving casirivimab/imdevimab or bamlanivimab, showing lower risk of hospitalization with treatment, statistically significant for casirivimab/imdevimab.
Feb 16
In Vitro Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 (Preprint) (In Vitro)
In Vitro
SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies
Details   In Vitro study showing that omicron BA.2 evades all monoclonal antibodies tested, including sotrovimab and tixagevimab/cilgavimab which retained activity for omicron BA.1.
Feb 9
Early Dale et al., Journal of the American Geriatrics Society, doi:10.1111/jgs.17705
death, ↓89.2%, p=0.010
Clinical Outcomes of Monoclonal Antibody Therapy During a COVID ‐19 Outbreak in a Skilled Nursing Facility‐Arizona, 2021
Details   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.
Jan 27
Early Delasobera et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001109
death, ↑119.4%, p=0.64
Impact of Rapidly Deployed COVID-19 Monoclonal Antibody Infusion Clinics on Rate of Hospitalization
Details   Retrospective 438 patients in the USA, 253 treated with bamlanivimab, showing significantly lower hospitalization with treatment.
Jan 27
Late Priest et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001130
death, 0.0%, p=1.00
Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2–Positive Patients in a Regional Health Care System
Details   Retrospective 379 bamlanivimab patients and 379 matched controls in the USA, showing no significant differences with treatment.
Dec 21
2021
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
2021
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
2021
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
2021
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
2021
Early Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546
death, ↓44.2%, p=1.00
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
2021
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
2021
Early Schiaroli et al., Mediterranean Journal of Hematology and Infectious Diseases, doi:10.4084/MJHID.2021.061 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
2021
Early Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512
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 7
2021
Early Dougan et al., New England Journal of Medicine, doi:10.1056/NEJMoa2102685
death, ↓94.7%, p=0.002
Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19
Details   Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. NCT04427501.
Oct 1
2021
Late Ganesh et al., Journal of Clinical Investigation, doi:10.1172/JCI151697
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
2021
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
2021
Early Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331
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
2021
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
2021
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.
Jan 21
2021
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
2021
Early Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202
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 combination..
Dec 22
2020
Late ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130
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
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 p..
Please send us corrections, updates, or comments. Vaccines and treatments are both valuable and complementary. All practical, effective, and safe means should be used. 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. FLCCC and WCH provide treatment protocols.
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