早期高滴度血浆疗法预防老年人重症 COVID-19。
Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults.
机构信息
From Fundación INFANT (R. Libster, S.C., A.B., I.E., M.T.C., C.W., D.A.P., S.E., A.F., G.O., S.S.A., C.S.Y., J.D.L., S.J.B., S.L., F.N., F.P.P.), iTrials (R. Libster, G.P.M., D.W., S.C., A.B., V.B., S.S.A., F.P.P.), Swiss Medical Group (D.W., J.L., F.E., J.M.), National Scientific and Technical Research Council (M.T.C., D.A.P., S.E.), Hospital Dr. Carlos Bocalandro (A.R., G. Lescano), Centro Gallego (P.C.), Instituto de Efectividad Clínica y Sanitaria (M.B., A.C., R.R., L.G., E.B.), Hospital Simplemente Evita (V.F.V.), CEMIC (R.V.), Fundación Hematológica Sarmiento (F. Alvez), Hospital Municipal San Isidro, (R. Larrea), Sanatorio Anchorena Recoleta (M.S.), Sanatorio Sagrado Corazón, Obra Social de los Empleados de Comercio y Actividades Civiles (G. Leberzstein), Ministerio de Salud de la Provincia de Buenos Aires (A.D., N.K.), Sanatorio Finochietto (M.G.), Programa de Atención Médica Integral (E.P.), Hospital Militar Central (G.P.M., V.B., C.W., N.I., A.H., M.L.O., C.E., A.N., I.N., J.A., R.L.C., G.C., S.R., F.D., D.A., S.P.A.), and Hospital San Juan de Dios (Y.R.) - all in Buenos Aires; the University of Oklahoma, Norman (G.O.); and the United Nations Development Program-United Nations Population Fund-United Nations Children's Fund-World Health Organization-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva (F. Althabe).
出版信息
N Engl J Med. 2021 Feb 18;384(7):610-618. doi: 10.1056/NEJMoa2033700. Epub 2021 Jan 6.
BACKGROUND
Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness.
METHODS
We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible.
RESULTS
A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P = 0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed.
CONCLUSIONS
Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19. (Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163.).
背景
用于阻断轻症 2019 年冠状病毒病（COVID-19）进展的疗法仍然难以捉摸。其中，用于住院患者的恢复期血浆治疗并未成功，这或许是因为抗体应该在疾病早期使用。
方法
我们对在 COVID-19 轻症症状发作后 72 小时内的老年患者进行了一项针对针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的高 IgG 滴度恢复期血浆的随机、双盲、安慰剂对照试验。主要终点是严重呼吸道疾病，定义为呼吸频率每分钟 30 次或以上，患者在呼吸环境空气时血氧饱和度低于 93%，或两者兼有。由于试验地区的 COVID-19 病例大幅减少，试验患者的稳定入组几乎变得不可能，因此该试验在预计样本量的 76%时提前停止。
结果
共有 160 名患者接受了随机分组。在意向治疗人群中，接受恢复期血浆的 80 名患者中有 13 名（16%）和接受安慰剂的 80 名患者中有 25 名（31%）发生严重呼吸道疾病（相对风险，0.52；95%置信区间[CI]，0.29 至 0.94；P=0.03），相对风险降低 48%。排除 6 名在输注恢复期血浆或安慰剂之前发生主要终点事件的患者的改良意向治疗分析显示出更大的效果量（相对风险，0.40；95%CI，0.20 至 0.81）。未观察到征求的不良事件。
结论
对轻度感染的老年感染患者早期使用针对 SARS-CoV-2 的高滴度恢复期血浆可减缓 COVID-19 的进展。（由比尔及梅琳达·盖茨基金会和 INFANT 大流行基金资助；Dirección de Sangre y Medicina Transfusional del Ministerio de Salud 编号 PAEPCC19，Plataforma de Registro Informatizado de Investigaciones en Salud 编号 1421，以及 ClinicalTrials.gov 编号 NCT04479163）。
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