SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
By Peter Chen, A. Nirula, B. Heller, R. Gottlieb, J. Boscia, J. Morris, G. Huhn, Jose Cardona, Bharat Mocherla, Valentina Stosor and 12 more. New England Journal of Medicine, 2020
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Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization. Methods In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here. Results At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was −3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was −0.53 (95% confidence interval [CI], −0.98 to −0.08; P=0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (−0.20; 95% CI, −0.66 to 0.25; P=0.38) or the 7000-mg dose (0.09; 95% CI, −0.37 to 0.55; P=0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19–related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group. Conclusions In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.)
Subfields: Infectious Diseases, Molecular Biology
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Citations in the corpus
- Prevention of severe COVID-19 in the elderly by early high-titer plasma therapy (2021, neutral): “Recently, the FDA granted emergency use authorization for monoclonal antibodies (mAbs) to treat outpatient mild to moderate COVID-19 based on clinical benefits pre-defined in secondary endpoints [ 18,19 ].”
- SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies (2021, critical): “Finally, entry mediated by the S proteins of the B.1.351 and P.1 variant was completely resistant to REGN10989 and Bamlanivimab, while the S protein of the B.1.1.7 variant was efficiently blocked by all antibodies tested (Figure 6).”
- COVID-19: angiotensin-converting enzyme 2 (ACE2) expression and tissue susceptibility to SARS-CoV-2 infection (2021, background): “Recently, an interim analysis of a phase 2 trial demonstrated the therapeutic potential of the LY-CoV55 neutralizing antibody in patients with mild and moderate COVID-19 [144].”
- Identification of SARS-CoV-2 spike mutations that attenuate monoclonal and serum antibody neutralization (2021, background): “Therapeutic candidates that have received emergency use authorization (EUA) or are in development include several monoclonal antibodies (mAbs) (ACTIV-3/TICO LY-CoV555 Study Group, 2020; Chen et al., 2021; Weinreich et al., 2021) that recognize the SARS-CoV-2 spike (S) protein, which decorates the vi”
- Adaptive immunity to SARS-CoV-2 and COVID-19 (2021, critical): “Injection of high doses of SARS-CoV-2 neutralizing monoclonal antibodies into SARS-CoV-2-infected humans had relatively limited effects on COVID-19 in clinical trials (Chen et al., 2020; Weinreich et al., 2020).”