SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
Open accessAbstract
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.).
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The effect of monoclonal antibodies was dose dependent and greater in patients lacking endogenous antibody responses.
“This effect was dose dependent and was greater for those patients who lacked endogenous antibody responses.”
From Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection (2021) · cites this paper as [37]
Administration of SARS-CoV-2-specific monoclonal antibodies within the first week of symptoms in mild-to-moderate infection seems to accelerate viral clearance and reduce risk of clinical progression.
“Evidence for this comes from studies involving the administration of SARS-CoV-2-specific monoclonal antibodies within the first week of symptoms in mild-to-moderate SARS-CoV-2 infection, which seems to accelerate the clearance of virus and reduce the risk of clinical progression36,37.”
From Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection (2021) · cites this paper as [37]
The S protein of SARS-CoV-2 is the main target for neutralizing antibodies.
“Further, the S protein of SARS-CoV-2 is the main target for neutralizing antibodies, and several recombinant neutralizing antibodies have been granted Emergency Use Authorization (EUA) for COVID-19 treatment (Baum et al., 2020a; Chen et al., 2020).”
From SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies (2021) · cites this paper as Chen et al., 2020
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- Authors
- Chen, P., Nirula, A., Heller, B., Gottlieb, R. L., Boscia, J., Morris, J., Huhn, G., Cardona, J., Mocherla, B., Stosor, V., Shawa, I., Adams, A. C., Van Naarden, J., Custer, K. L., Shen, L., Durante, M., Oakley, G., Schade, A. E., Sabo, J., Patel, D. R., Klekotka, P., & Skovronsky, D. M.
- Affiliations
- Cedars-Sinai Medical Center (US)
- From the Department of Medicine, Women’s Guild Lung Institute, Cedars–Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) — both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) — both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health,...
- Corresponding author
- Skovronsky, Daniel M.
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-01-21
- Volume
- 384
- Issue
- 3
- Pages
- 229-237
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7646625
- OpenAlex
- W3096658347
- Cited by
- 1,282
- References
- 25
- Citations by year
- 2026: 13 · 2025: 44 · 2024: 106 · 2023: 149 · 2022: 324 · 2021: 604 · 2020: 42
- FWCI
- 36.66
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- SARS-CoV-2, COVID-19 pandemic, neutralizing monoclonal antibodies, viral load, mild to moderate COVID-19, outpatients, dose comparison, hospitalization, symptom severity, treatment efficacy, SARS-CoV-2 spike protein, BNT162b2, emergency department visits
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Adolescent, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Female, Hospitalization, Humans, Immunologic Factors, Male, Middle Aged, Outpatients, RNA, Viral, Severity of Illness Index, Viral Load, Reverse Transcriptase Polymerase Chain Reaction, Young Adult, Antibodies, Neutralizing, Antibodies, Monoclonal, Humanized
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