丹麦哥本哈根大学Jens D. Lundgren团队研究了中和单克隆抗体治疗Covid-19住院患者的疗效。2020年12月22日，该研究发表在《新英格兰医学杂志》上。

LY-CoV555是一种中和性单克隆抗体，可降低Covid-19门诊患者的病毒载量，并减少其住院或急诊就诊的频率。但该抗体治疗Covid-19住院患者的疗效尚未明确。

在该治疗药物试验中，研究组招募了314例患Covid-19且无终末器官衰竭的住院患者，将其按1：1随机分组，其中163例接受LY-CoV555静脉输注治疗，151例接受匹配的安慰剂输注。此外，所有患者均接受了高质量的支持治疗作为背景治疗，包括抗病毒药物瑞德西韦，以及在需要时补充氧气和糖皮质激素。主要结局为90天内的持续恢复。

从有症状到发病的中位间隔为7天。在第5天，LY-CoV555组中有81名患者（50%），安慰剂组中有81名患者（54%）属于两种最有利的肺预后类型之一。在7个类别中，LY-CoV555组与安慰剂组相比，处于更有利类别的比值比为0.85，差异不显著。LY-CoV555组中有19%的患者发生主要安全结局，包括死亡、严重不良事件或临床3-4级不良事件的复合结果，安慰剂组中有14%，差异不显著。两组间持续恢复的比率为1.06。

研究结果表明，单克隆抗体LY-CoV555与瑞德西韦联合使用治疗未发生终末器官衰竭的Covid-19住院患者，疗效并不显著。

附：英文原文

Title: A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

Author: ACTIV-/TICO LY-CoV Study Group

Issue&Volume: 2020-12-22

Abstract:

BACKGROUND

LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.

METHODS

In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5.

RESULTS

On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P=0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P=0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).

CONCLUSIONS

Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure.

DOI: 10.1056/NEJMoa2033130

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2033130