TY - JOUR
T1 - SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19
AU - Chen, Peter
AU - Nirula, Ajay
AU - Heller, Barry
AU - Gottlieb, Robert L.
AU - Boscia, Joseph
AU - Morris, Jason
AU - Huhn, Gregory
AU - Cardona, Jose
AU - Mocherla, Bharat
AU - Stosor, Valentina
AU - Shawa, Imad
AU - Adams, Andrew C.
AU - Naarden, Jacob Van
AU - Custer, Kenneth L.
AU - Shen, Lei
AU - Durante, Michael
AU - Oakley, Gerard
AU - Schade, Andrew E.
AU - Sabo, Janelle
AU - Patel, Dipak R.
AU - Klekotka, Paul
AU - Skovronsky, Daniel M.
N1 - Publisher Copyright:
© 2020 Massachusetts Medical Society.
PY - 2021/1/21
Y1 - 2021/1/21
N2 - 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 lifethreatening. 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 LYCoV555, 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.
AB - 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 lifethreatening. 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 LYCoV555, 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.
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U2 - 10.1056/NEJMoa2029849
DO - 10.1056/NEJMoa2029849
M3 - Article
C2 - 33113295
AN - SCOPUS:85098855067
SN - 0028-4793
VL - 384
SP - 229
EP - 237
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 3
ER -
