Figueroa Juan Manuel, Lombardo Mónica Edith, Dogliotti Ariel, Flynn Luis Pedro, Giugliano Robert, Simonelli Guido, Valentini Ricardo, Ramos Agñel, Romano Pablo, Marcote Marcelo, Michelini Alicia, Salvado Alejandro, Sykora Emilio, Kniz Cecilia, Kobelinsky Marcelo, Salzberg David Manuel, Jerusalinsky Diana, Uchitel Osvaldo
Sleep and Respiratory Research Center, Instituto de Ciencia y Tecnología Cesar Milstein, Ciudad Autónoma de Buenos Aires, Argentina.
Clinical Research Unit, Hospital Universitario CEMIC, Ciudad Autónoma de Buenos Aires, Argentina.
Int J Gen Med. 2021 Oct 1;14:6277-6286. doi: 10.2147/IJGM.S328486. eCollection 2021.
Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture.
Can a nasal spray with Iota-Carrageenan be useful in the prophylaxis of COVID-19 in health care workers managing patients with COVID-19 disease?
This is a pilot pragmatic multicenter, randomized, double-blind, placebo-controlled study assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and other health care providers managing patients hospitalized for COVID-19 were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse transcriptase polymerase chain reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322).
A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 differs significantly between subjects receiving the nasal spray with I-C (2 of 196 [1.0%]) and those receiving placebo (10 of 198 [5.0%]). Relative risk reduction: 79.8% (95% CI 5.3 to 95.4; p=0.03). Absolute risk reduction: 4% (95% CI 0.6 to 7.4).
In this pilot study a nasal spray with I-C showed significant efficacy in preventing COVID-19 in health care workers managing patients with COVID-19 disease.
NCT04521322.
ι-角叉菜胶（I-C）是一种由红藻合成的硫酸多糖，具有抗病毒活性，作为鼻喷雾剂治疗普通感冒具有临床疗效。在体外，I-C可抑制细胞培养中的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染。
含ι-角叉菜胶的鼻喷雾剂对护理新冠肺炎患者的医护人员预防新冠病毒病（COVID-19）是否有用？
这是一项实用的多中心、随机、双盲、安慰剂对照的试点研究，评估含I-C的鼻喷雾剂对专门护理新冠肺炎患者的医院工作人员预防COVID-19的作用。管理因COVID-19住院患者的临床健康医生、护士、运动机能学家和其他医护人员按1:1的比例分配，接受为期21天、每日4剂的I-C喷雾剂或安慰剂。主要终点是在21天内通过逆转录聚合酶链反应检测确诊的临床COVID-19。该试验已在ClinicalTrials.gov注册（NCT04521322）。
共有394人被随机分配接受I-C或安慰剂。两个治疗组的基线特征相似。接受含I-C鼻喷雾剂的受试者（196人中有2人[1.0%]）和接受安慰剂的受试者（198人中有10人[5.0%]）之间，COVID-19的发病率有显著差异。相对风险降低：79.8%（95%置信区间5.3至95.4；p=0.03）。绝对风险降低：4%（95%置信区间0.6至7.4）。
在这项试点研究中，含I-C的鼻喷雾剂在预防护理新冠肺炎患者的医护人员感染COVID-19方面显示出显著疗效。
NCT04521322。
