SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

In a phase 2 trial, outpatients with Covid-19 who received a single infusion of a 2800-mg dose of the neutralizing antibody LY-CoV555 had a greater reduction from baseline in viral load than those who received placebo. Hospitalization was less frequent among antibody-treated patients (1.6% vs. 6.3%)...

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Published in:The New England journal of medicine Vol. 384; no. 3; pp. 229 - 237
Main Authors: Chen, Peter, Nirula, Ajay, Heller, Barry, Gottlieb, Robert L, Boscia, Joseph, Morris, Jason, Huhn, Gregory, Cardona, Jose, Mocherla, Bharat, Stosor, Valentina, Shawa, Imad, Adams, Andrew C, Van Naarden, Jacob, Custer, Kenneth L, Shen, Lei, Durante, Michael, Oakley, Gerard, Schade, Andrew E, Sabo, Janelle, Patel, Dipak R, Klekotka, Paul, Skovronsky, Daniel M
Format: Journal Article
Language:English
Published: United States Massachusetts Medical Society 21.01.2021
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ISSN:0028-4793, 1533-4406, 1533-4406
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Abstract In a phase 2 trial, outpatients with Covid-19 who received a single infusion of a 2800-mg dose of the neutralizing antibody LY-CoV555 had a greater reduction from baseline in viral load than those who received placebo. Hospitalization was less frequent among antibody-treated patients (1.6% vs. 6.3%).
AbstractList 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.BACKGROUNDSevere 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.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.METHODSIn 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.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.RESULTSAt 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.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.).CONCLUSIONSIn 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.).
In a phase 2 trial, outpatients with Covid-19 who received a single infusion of a 2800-mg dose of the neutralizing antibody LY-CoV555 had a greater reduction from baseline in viral load than those who received placebo. Hospitalization was less frequent among antibody-treated patients (1.6% vs. 6.3%).
BackgroundSevere 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.MethodsIn 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.ResultsAt 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.ConclusionsIn 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.)
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. 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. 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. 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.).
Author Sabo, Janelle
Boscia, Joseph
Van Naarden, Jacob
Durante, Michael
Huhn, Gregory
Shen, Lei
Gottlieb, Robert L
Stosor, Valentina
Nirula, Ajay
Custer, Kenneth L
Skovronsky, Daniel M
Schade, Andrew E
Heller, Barry
Oakley, Gerard
Adams, Andrew C
Patel, Dipak R
Morris, Jason
Cardona, Jose
Mocherla, Bharat
Chen, Peter
Shawa, Imad
Klekotka, Paul
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  givenname: Peter
  surname: Chen
  fullname: Chen, Peter
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  surname: Nirula
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Barry
  surname: Heller
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 4
  givenname: Robert L
  surname: Gottlieb
  fullname: Gottlieb, Robert L
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Joseph
  surname: Boscia
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Jason
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Gregory
  surname: Huhn
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Jose
  surname: Cardona
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 9
  givenname: Bharat
  surname: Mocherla
  fullname: Mocherla, Bharat
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 10
  givenname: Valentina
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  fullname: Stosor, Valentina
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Imad
  surname: Shawa
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  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Andrew C
  surname: Adams
  fullname: Adams, Andrew C
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Jacob
  surname: Van Naarden
  fullname: Van Naarden, Jacob
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Kenneth L
  surname: Custer
  fullname: Custer, Kenneth L
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
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  givenname: Lei
  surname: Shen
  fullname: Shen, Lei
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 16
  givenname: Michael
  surname: Durante
  fullname: Durante, Michael
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 17
  givenname: Gerard
  surname: Oakley
  fullname: Oakley, Gerard
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 18
  givenname: Andrew E
  surname: Schade
  fullname: Schade, Andrew E
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 19
  givenname: Janelle
  surname: Sabo
  fullname: Sabo, Janelle
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 20
  givenname: Dipak R
  surname: Patel
  fullname: Patel, Dipak R
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 21
  givenname: Paul
  surname: Klekotka
  fullname: Klekotka, Paul
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
– sequence: 22
  givenname: Daniel M
  surname: Skovronsky
  fullname: Skovronsky, Daniel M
  organization: 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, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/33113295$$D View this record in MEDLINE/PubMed
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Copyright © 2020 Massachusetts Medical Society.
This article is made available via the PMC Open Access Subset for unrestricted re-use, except commercial resale, and analyses in any form or by any means with acknowledgment of the original source. These permissions are granted for the duration of the Covid-19 pandemic or until revoked in writing. Upon expiration of these permissions, PMC is granted a license to make this article available via PMC and Europe PMC, subject to existing copyright protections.
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A list of the BLAZE-1 investigators is provided in the Supplementary Appendix, available at NEJM.org.
Drs. Chen and Nirula contributed equally to this article.
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Snippet In a phase 2 trial, outpatients with Covid-19 who received a single infusion of a 2800-mg dose of the neutralizing antibody LY-CoV555 had a greater reduction...
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...
BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be...
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...
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StartPage 229
SubjectTerms Adolescent
Adult
Aged
Aged, 80 and over
Antibodies
Antibodies, Monoclonal, Humanized - administration & dosage
Antibodies, Monoclonal, Humanized - adverse effects
Antibodies, Neutralizing - administration & dosage
Antibodies, Neutralizing - adverse effects
Asymptomatic
Clinical outcomes
Coronaviridae
Coronaviruses
COVID-19
COVID-19 - drug therapy
COVID-19 - virology
Disease
Dose-Response Relationship, Drug
Double-Blind Method
Emergency medical care
Female
Hospitalization - statistics & numerical data
Humans
Immunologic Factors - administration & dosage
Immunologic Factors - adverse effects
International organizations
Intravenous administration
Male
Medical research
Middle Aged
Monoclonal antibodies
Original
Outpatients
Pandemics
Patients
Placebos
Reverse Transcriptase Polymerase Chain Reaction
Ribonucleic acid
Risk factors
RNA
RNA, Viral - blood
SARS-CoV-2 - genetics
SARS-CoV-2 - isolation & purification
Severe acute respiratory syndrome coronavirus 2
Severity of Illness Index
Statistical analysis
Viral Load - drug effects
Young Adult
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Title SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
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