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0 0.5 1 1.5 2+ Mortality 95% Improvement Relative Risk Death/hospitalization 70% primary Recovery time 11% Viral clearance 67% Bamlanivimab/e..  Dougan et al.  EARLY TREATMENT  DB RCT Is early treatment with bamlanivimab/etesevimab beneficial for COVID-19? Double-blind RCT 1,035 patients in the USA (September - December 2020) Lower mortality (p=0.0019) and death/hosp. (p=0.00016) Dougan et al., New England J. Medicine, Oct 2021 Favors bamlanivimab/e.. Favors control

Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19

Dougan et al., New England Journal of Medicine, doi:10.1056/NEJMoa2102685, NCT04427501
Oct 2021  
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23rd treatment shown to reduce risk in June 2021
*, now known with p = 0.0005 from 17 studies, recognized in 3 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments.
Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. NCT04427501 (history).
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron Haars, Liu, Pochtovyi, Sheward, VanBlargan.
risk of death, 94.7% lower, RR 0.05, p = 0.002, treatment 0 of 518 (0.0%), control 9 of 517 (1.7%), NNT 57, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), COVID-19 deaths.
risk of death/hospitalization, 69.5% lower, RR 0.30, p < 0.001, treatment 11 of 518 (2.1%), control 36 of 517 (7.0%), NNT 21, primary outcome.
recovery time, 11.1% lower, relative time 0.89, p = 0.007, treatment 518, control 517, sustained resolution of symptoms.
risk of no viral clearance, 66.6% lower, RR 0.33, p < 0.001, treatment 50 of 508 (9.8%), control 147 of 499 (29.5%), NNT 5.1, day 7, persistently high viral load.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Dougan et al., 7 Oct 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 33 authors, study period 4 September, 2020 - 8 December, 2020, average treatment delay 4.0 days, trial NCT04427501 (history).
This PaperBamlaniv../e..All
Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19
Michael Dougan, Ajay Nirula, Masoud Azizad, Bharat Mocherla, Robert L Gottlieb, Peter Chen, Corey Hebert, Russell Perry, Joseph Boscia, Barry Heller, Jason Morris, Chad Crystal, Awawu Igbinadolor, Gregory Huhn, Jose Cardona, Imad Shawa, Princy Kumar, Andrew C Adams, Jacob Van Naarden, Kenneth L Custer, Michael Durante, Gerard Oakley, Andrew E Schade, Timothy R Holzer, Philip J Ebert, Richard E Higgs, Nicole L Kallewaard, Janelle Sabo, Dipak R Patel, Matan C Dabora, Paul Klekotka, Lei Shen, Daniel M Skovronsky
New England Journal of Medicine, doi:10.1056/nejmoa2102685
BACKGROUND Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications. METHODS In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined as Covid-19-related hospitalization or death from any cause by day 29. RESULTS A total of 1035 patients underwent randomization and received an infusion of bamlanivimab-etesevimab or placebo. The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of 11 of 518 patients (2.1%) in the bamlanivimab-etesevimab group had a Covid-19related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, −4.8 percentage points; 95% confidence interval [CI], −7.4 to −2.3; relative risk difference, 70%; P<0.001). No deaths occurred in the bamlanivimab-etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19-related. At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, −1.20; 95% CI, −1.46 to −0.94; P<0.001). CONCLUSIONS Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19-related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly; BLAZE-1 number, NCT04427501.
Appendix The authors' full names and academic degrees are as follows: Michael Dougan, M.D., Ph.D., Ajay Nirula, M.D., Ph.D., Masoud Azizad, M.D., Bharat Mocherla, M.D., Robert L. Gottlieb
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