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0 0.5 1 1.5 2+ Hospitalization/ER 71% Improvement Relative Risk Hospitalization/ER (b) 80% Hospitalization/ER (c) 75% Hospitalization/ER (d) 56% Hospitalization/ER (e) 92% Gottlieb et al. Bamlanivimab/e.. for COVID-19 RCT EARLY Is early treatment with bamlanivimab/etesevimab beneficial for COVID-19? RCT 153 patients in the USA Fewer hosp./ER visits with bamlanivimab/etesevimab (p=0.046) Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 Favors bamlanivimab/e.. Favors control
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19
Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202
Gottlieb et al., Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to.., JAMA, doi:10.1001/jama.2021.0202
Jan 2021   Source   PDF  
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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.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, VanBlargan].
risk of hospitalization/ER, 70.6% lower, RR 0.29, p = 0.046, treatment 4 of 101 (4.0%), control 7 of 52 (13.5%), NNT 11, 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%), NNT 9.3, 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%), NNT 9.9, 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%), NNT 13, 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%), NNT 7.4, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), LY-CoV555/LY-CoV016.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gottlieb et al., 21 Jan 2021, Randomized Controlled Trial, USA, peer-reviewed, 27 authors, average treatment delay 4.0 days.
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This PaperBamlaniv../e..All
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19
MD, PhD Robert L Gottlieb, MD Ajay Nirula, Peter Chen, MD Joseph Boscia, MD Barry Heller, MD Jason Morris, MS Gregory Huhn, MD Jose Cardona, MD Bharat Mocherla, MD Valentina Stosor, MD Imad Shawa, MD Princy Kumar, PhD Andrew C Adams, BS Jacob Van Naarden, PhD; Kenneth L Custer, MS Michael Durante, MD Gerard Oakley, MD, PhD Andrew E Schade, PhD; Timothy R Holzer, PhD Philip J Ebert, PhD Richard E Higgs, PhD Nicole L Kallewaard, PharmD Janelle Sabo, MD Dipak R Patel, PhD Paul Klekotka, PhD Lei Shen, PhD; Daniel M Skovronsky
JAMA, doi:10.1001/jama.2021.0202
IMPORTANCE Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19. OBJECTIVE To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19. DESIGN, SETTING, AND PARTICIPANTS The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020. INTERVENTIONS Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156). MAIN OUTCOMES AND MEASURES The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29). RESULTS Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49for7000mg,-4.37forcombinationtreatment,and-3.80forplacebo.Comparedwithplacebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69)for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group werestatisticallysignificantfor10of84endpoints.TheproportionofpatientswithCOVID-19-related hospitalizationsorEDvisitswas5.8%(9events)forplacebo,1.0%(1event)for700mg,1.9%(2events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment. CONCLUSIONS AND RELEVANCE Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant..
Baum, Fulton, Wloga, Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies, Science, doi:10.1126/science.abd0831
Berlin, Gulick, Martinez, Severe Covid-19, N Engl J Med, doi:10.1056/NEJMcp2009575
Chen, Nirula, Heller, for the BLAZE-1
Garg, Kim, Whitaker, Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019-COVID-NET, 14 States, MMWR Morb Mortal Wkly Rep
Golub, Md, None
Huang, Wang, Li, Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, Lancet, doi:10.1016/S0140-6736(20)30183-5
Investigators, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med. Published online, doi:10.1056/NEJMoa2029849
Jones, Brown-Augsburger, Corbett, LY-CoV555, a rapidly isolated potent neutralizing antibody, provides protection in a non-human primate model of SARS-CoV-2 infection. bioRxiv, doi:10.1101/2020.09.30.318972
Joyner, Wright, Fairweather, Early safety indicators of COVID-19 convalescent plasma in 5000 patients, J Clin Invest, doi:10.1172/JCI140200
Ko, Danielson, Town, Risk factors for COVID-19-associated hospitalization: COVID-19-associated hospitalization surveillance network and behavioral risk factor surveillance system, Clin Infect Dis. Published online, doi:10.1093/cid/ciaa1419
Petrilli, Jones, Yang, Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study, BMJ, doi:10.1136/bmj.m1966
Preeti, Malani, Md, Msj, None
Shi, Shan, Duan, A human neutralizing antibody targets the receptor-binding site of SARS-CoV-2, Nature, doi:10.1038/s41586-020-2381-y
Williamson, Walker, Bhaskaran, Factors associated with COVID-19-related death using OpenSAFELY, Nature, doi:10.1038/s41586-020-2521-4
Wu, Chen, Cai, Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China, JAMA Intern Med, doi:10.1001/jamainternmed.2020.0994?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jama.2021.0202
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