Neutralizing Antibody in Outpatients with Covid-19 Table 2. Change from Baseline in Viral Load. LY-CoV555 Placebo Difference Variable (N = 309) (N = 143) (95% CI) Primary outcome Mean change from baseline in viral load at day 11 −3.47 700 mg, −3.67 −0.20 (−0.66 to 0.25) 2800 mg, −4.00 −0.53 (−0.98 to −0.08) 7000 mg, −3.38 0.09 (−0.37 to 0.55) Pooled doses, −3.70 −0.22 (−0.60 to 0.15) Secondary outcomes* Mean change from baseline in viral load at day 3 −0.85 700 mg, −1.27 −0.42 (−0.89 to 0.06) 2800 mg, −1.50 −0.64 (−1.11 to −0.17) 7000 mg, −1.27 −0.42 (−0.90 to 0.06) Pooled doses, −1.35 −0.49 (−0.87 to −0.11) Mean change from baseline in viral load at day 7 −2.56 700 mg, −2.82 −0.25 (−0.73 to 0.23) 2800 mg, −3.01 −0.45 (−0.92 to 0.03) 7000 mg, −2.85 −0.28 (−0.77 to 0.20) Pooled doses, −2.90 −0.33 (−0.72 to 0.06) * Data regarding hospitalization, another key secondary outcome, are provided in Table 3. Covid-19–Related Hospitalization domains that were graded from 0 (no symp- At day 29, the percentage of patients who were toms) to 3 (severe symptoms). From day 2 to day hospitalized with Covid-19 was 1.6% (5 of 309 6, the change in the symptom score from base- patients) in the LY-CoV555 group and 6.3% (9 of line was better in the LY-CoV555 group than in 143 patients) in the placebo group (Table 3). The the placebo group, with values of −0.79 (95% CI, percentage of patients according to the LY-CoV555 −1.35 to −0.24) on day 2, −0.57 (95% CI, −1.12 dose who were hospitalized was similar to the to −0.01) on day 3, −1.04 (95% CI, −1.60 to −0.49) overall percentage, with 1.0% (1 of 101) in the on day 4, −0.73 (95% CI, −1.28 to −0.17) on day 5, 700-mg subgroup, 1.9% (2 of 107) in the 2800-mg and −0.79 (95% CI, −1.35 to −0.23) on day 6. The subgroup, and 2.0% (2 of 101) in the 7000-mg change from baseline in the symptom score con- subgroup. In a post hoc analysis examining hos- tinued to be better in the LY-CoV555 group than pitalization among patients who were 65 years in the placebo group from day 7 to day 11, al- of age or older and among those with a BMI of though by these time points most of the patients 35 or more, the percentage who were hospital- in the two groups had fully recovered or had ized was 4% (4 of 95) in the LY-CoV555 group and only very mild symptoms. 15% (7 of 48) in the placebo group. Only 1 patient in the trial (in the placebo group) was admitted Safety to an intensive care unit. Serious adverse events occurred in none of the 309 patients in LY-CoV555 group and in 0.7% Symptom Score (1 of 143 patients) in the placebo group (Ta- To assess the effect of treatment on Covid-19 ble 4). The percentage of patients who had an symptoms, we compared the change from base- adverse event during treatment was 22.3% (69 of line in symptom scores between the LY-CoV555 309) in the LY-CoV555 group and 24.5% (35 of 143) group and the placebo group (Fig. 3 and Fig. S1 in the placebo group. Diarrhea was reported in in the Supplementary Appendix). The symptom 3.2% of the patients (10 of 309) in the LY-CoV555 score ranged from 0 to 24 and included eight group and in 4.9% (7 of 143) in the placebo n engl j med nejm.org 5 The New England Journal of Medicine Downloaded from nejm.org on November 19, 2020. For personal use only. No other uses without permission. Copyright © 2020 Massachusetts Medical Society. All rights reserved.