Laboratorio de Infectologia Pediátrica, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
Facultad de Medicina Alberto Hurtado, Universidad Peruana Cayetano Heredia, Lima, Peru.
Biometals. 2023 Jun;36(3):463-472. doi: 10.1007/s10534-022-00477-3. Epub 2022 Dec 7.
Lactoferrin (LF) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to determine the effect of bovine lactoferrin (bLF) in the prevention of SARS-CoV-2 infection in health care personnel. A randomized, double-blinded, placebo-controlled clinical trial was conducted in two tertiary hospitals that provide care to patients with SARS-CoV-2 infection in Lima, Peru. Daily supplementation with 600 mg of enteral bLF versus placebo for 90 days was compared. Participants were weekly screened for symptoms suggestive of SARS-CoV-2 infection and molecular testing was performed on suspected episodes. A serological test was obtained from all participants at the end of the intervention. The main outcome included symptomatic and asymptomatic cases. A sub-analysis explored the time to symptomatic infection. Secondary outcomes were the severity, frequency, and duration of symptomatic infection. The study was prematurely cancelled due to the availability of vaccines against SARS-CoV-2 in Peru. 209 participants were enrolled and randomized, 104 received bLF and 105 placebo. SARS-CoV-2 infection occurred in 11 (10.6%) participants assigned to bLF and in 9 (8.6%) participants assigned to placebo without significant differences (Incidence Rate Ratio = 1.23, 95%CI 0.51-3.06, p-value = 0.64). There was no significant effect of bLF on time to symptomatic infection (Hazard Ratio = 1.61, 95%CI 0.62-4.19, p-value = 0.3). There were no significant differences in secondary outcomes. A significant effect of bLF in preventing SARS-CoV-2 infection was not proven. Further studies are needed to assess the effect of bLF supplementation on SARS-CoV-2 infection.Clinical trial registration ClinicalTrials.gov Identifier: NCT04526821, https://clinicaltrials.gov/ct2/show/NCT04526821?term=LACTOFERRIN&cond=COVID-19&cntry=PE&city=Lima&draw=2&rank=1 .
乳铁蛋白 (LF) 具有体外抗严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的活性。本研究旨在确定牛乳铁蛋白 (bLF) 对预防医护人员 SARS-CoV-2 感染的效果。在秘鲁利马的两家为 SARS-CoV-2 感染患者提供护理的三级医院进行了一项随机、双盲、安慰剂对照的临床试验。比较了每日补充 600mg 肠内 bLF 与安慰剂 90 天的效果。参与者每周筛查 SARS-CoV-2 感染症状，并对疑似病例进行分子检测。所有参与者在干预结束时都进行了血清学检测。主要结局包括有症状和无症状病例。一项亚分析探讨了有症状感染的时间。次要结局是有症状感染的严重程度、频率和持续时间。由于秘鲁有针对 SARS-CoV-2 的疫苗，该研究提前终止。共纳入 209 名参与者并进行随机分组，104 名接受 bLF 治疗，105 名接受安慰剂治疗。bLF 组有 11 名（10.6%）参与者和安慰剂组有 9 名（8.6%）参与者发生 SARS-CoV-2 感染，差异无统计学意义（发病率比=1.23，95%CI 0.51-3.06，p 值=0.64）。bLF 对有症状感染时间无显著影响（风险比=1.61，95%CI 0.62-4.19，p 值=0.3）。次要结局无显著差异。未证明 bLF 对预防 SARS-CoV-2 感染有显著效果。需要进一步研究评估 bLF 补充剂对 SARS-CoV-2 感染的影响。临床试验注册 ClinicalTrials.gov 标识符：NCT04526821，https://clinicaltrials.gov/ct2/show/NCT04526821?term=LACTOFERRIN&cond=COVID-19&cntry=PE&city=Lima&draw=2&rank=1 。
