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0 0.5 1 1.5 2+ Mortality -100% Improvement Relative Risk ACTIV-3/TICO et al. NCT04501978 ACTIV-3 Bamlanivimab/e.. RCT LATE Is late treatment with bamlanivimab/etesevimab beneficial for COVID-19? RCT 314 patients in the USA Higher mortality with bamlanivimab/etesevimab (not stat. sig., p=0.22) ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 Favors bamlanivimab/e.. Favors control

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130, ACTIV-3, NCT04501978 (history)
ACTIV-3/TICO, A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19, LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130, ACTIV-3, NCT04501978
Dec 2020   Source   PDF  
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Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, VanBlargan].
risk of death, 100% higher, HR 2.00, p = 0.22, treatment 9 of 163 (5.5%), control 5 of 151 (3.3%), adjusted per study, proportional hazards regression.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
ACTIV-3/TICO et al., 22 Dec 2020, Randomized Controlled Trial, USA, peer-reviewed, 1 author, average treatment delay 7.0 days, trial NCT04501978 (history) (ACTIV-3).
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A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19
J D Lundgren, B Grund, C E Barkaus- Kas, T L Holland, R L Gottlieb, U Sand- Kovsky, S M Brown, K U Knowlton, W H Self, D C Files, M K Jain, T Benfield, M E Bowdish, B G Leshnower, J V Bak- Er, J.-U Jensen, E M Gardner, A A Ginde, E S Harris, I S Johansen, N Markowitz, M A Matthay, L Østergaard, C C Chang, V J Davey, A Goodman, E S Higgs, D D Murray, T A Murray, R Paredes, M K B Parmar, A N Phillips, C Reilly, S Sharma, R L Dewar, M Teitelbaum, D Wentworth, H Cao, P Klekotka, A G Babiker, A C Gelijns, V L Kan, M N Polizzotto, B T Thompson, H C Lane, J D Neaton, / Tico Ly-Cov555, Study Group
New England Journal of Medicine, doi:10.1056/nejmoa2033130
BACKGROUND LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19. METHODS In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5. RESULTS On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). CONCLUSIONS Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO number, NCT04501978.
Arvin, Fink, Schmid, A perspective on potential antibodydependent enhancement of SARS-CoV-2, Nature
Baum, Fulton, Wloga, Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies, Science
Beigel, Tomashek, Dodd, Remdesivir for the treatment of Covid-19 -final report, N Engl J Med
Chen, Nirula, Heller, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2029849
Core, R: a language and environment for statistical computing
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, doi:10.1101/2020.09.30.318972v3
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Mccullagh, Regression models for ordinal data, J R Stat Soc B
Mulangu, Dodd, Rt, A randomized, controlled trial of Ebola virus disease therapeutics, N Engl J Med
Murray, Babiker, Baker, Design and implementation of the multi-arm, multi-stage Therapeutics for Inpatients with COVID-19 (TICO) platform master protocol: an Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, doi:10.1101/2020.11.08.20227876v2
The, Group, Dexamethasone in hospitalized patients with Covid-19 -preliminary report, N Engl J Med, doi:10.1056/NEJMoa2021436
Weisblum, Schmidt, Zhang, Escape from neutralizing antibodies by SARS-CoV-2 spike protein variants, doi:10.1101/2020.07.21.214759v1
Late treatment
is less effective
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