Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Clin Infect Dis. 2024 Oct 15;79(4):920-927. doi: 10.1093/cid/ciae324.
Reliable biomarkers of coronavirus disease 2019 (COVID-19) outcomes are critically needed. We evaluated associations of spike antibody (Ab) and plasma nucleocapsid antigen (N Ag) with clinical outcomes in nonhospitalized persons with mild-to-moderate COVID-19.
Participants were nonhospitalized adults with mild-to-moderate COVID-19 enrolled in ACTIV-2 between January and July 2021 and randomized to placebo. We used quantitative assays for severe acute respiratory syndrome coronavirus 2 spike Ab and N Ag in blood and determined numbers of hospitalization/death events within 28 days and time to symptom improvement.
Of 209 participants, 77 (37%) had quantifiable spike Ab and 139 (67%) quantifiable N Ag. Median age was 50 years; 111 (53%) were female, 182 (87%) White, and 105 (50%) Hispanic/Latino. Higher risk of hospitalization/death was seen with unquantifiable (22/132 [16.7%]) versus quantifiable (1/77 [1.3%]) spike Ab (risk ratio [RR], 12.83 [95% confidence interval {CI}, 1.76-93.34]) and quantifiable (22/139 [15.8%]) vs unquantifiable (1/70 [1.4%]) N Ag (RR, 11.08 [95% CI, 1.52-80.51]). Increasing risk of hospitalizations/deaths was seen with increasing N Ag levels. Time to symptom improvement was longer with unquantifiable versus quantifiable spike Ab (median, 14 [interquartile range {IQR}, 8 to >27] vs 8 [IQR, 4-22] days; adjusted hazard ratio [aHR], 0.66 [95% CI, .45-.96]) and with quantifiable versus unquantifiable N Ag (median, 12 [7 to >27] vs 10 [5-22] days; aHR, 0.79 [95% CI, .52-1.21]).
Absence of spike Ab and presence of plasma N Ag predicted hospitalization/death and delayed symptom improvement in COVID-19 outpatients.
NCT04518410.
迫切需要可靠的 2019 年冠状病毒病（COVID-19）结局的生物标志物。我们评估了非住院轻至中度 COVID-19 患者中刺突抗体（Ab）和血浆核衣壳抗原（N Ag）与临床结局的关联。
参与者为 2021 年 1 月至 7 月期间在 ACTIV-2 中招募的非住院轻至中度 COVID-19 成年患者，并随机分配至安慰剂组。我们使用血液中严重急性呼吸综合征冠状病毒 2 刺突 Ab 和 N Ag 的定量检测，并确定 28 天内住院/死亡事件的数量和症状改善时间。
在 209 名参与者中，77 名（37%）有可量化的刺突 Ab，139 名（67%）有可量化的 N Ag。中位年龄为 50 岁；111 名（53%）为女性，182 名（87%）为白人，105 名（50%）为西班牙裔/拉丁裔。无法量化的刺突 Ab（22/132 [16.7%]）与可量化的刺突 Ab（1/77 [1.3%]）相比，住院/死亡风险更高（风险比[RR]，12.83 [95%置信区间{CI}，1.76-93.34]），可量化的 N Ag（22/139 [15.8%]）与无法量化的 N Ag（1/70 [1.4%]）相比，住院/死亡风险更高（RR，11.08 [95% CI，1.52-80.51]）。N Ag 水平越高，住院/死亡的风险越大。与可量化的刺突 Ab 相比，无法量化的刺突 Ab 导致症状改善的时间更长（中位数，14 [四分位距 {IQR}，8 至 >27] 与 8 [IQR，4-22] 天；调整后的危险比[aHR]，0.66 [95% CI，0.45-0.96]），与可量化的 N Ag 相比，无法量化的刺突 Ab 导致症状改善的时间更长（中位数，12 [7 至 >27] 与 10 [5-22] 天；aHR，0.79 [95% CI，0.52-1.21]）。
刺突 Ab 缺失和血浆 N Ag 存在预测了 COVID-19 门诊患者的住院/死亡和症状改善延迟。
NCT04518410。
