Morokutti-Kurz Martina, Unger-Manhart Nicole, Graf Philipp, Rauch Pia, Kodnar Julia, Große Maximilian, Setz Christian, Savli Markus, Ehrenreich Friedrich, Grassauer Andreas, Prieschl-Grassauer Eva, Schubert Ulrich
Marinomed Biotech AG, Korneuburg, 2100, Austria.
Institute of Virology, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.
Int J Gen Med. 2021 Sep 7;14:5241-5249. doi: 10.2147/IJGM.S325861. eCollection 2021.
The aim of this study was to investigate whether sucking of an iota-carrageenan containing lozenge releases sufficient iota-carrageenan into the saliva of healthy subjects to neutralize representatives of the most common respiratory virus families causing common cold and SARS-CoV-2.
In this monocentric, open label, prospective clinical trial, 31 healthy subjects were included to suck a commercially available iota-carrageenan containing lozenge. Saliva samples from 27 subjects were used for ex vivo efficacy analysis. The study's primary objective was to assess if the mean iota-carrageenan concentration of the saliva samples exceeded 5 µg/mL, which is the concentration known to reduce replication of human rhinovirus (hRV) 1a and 8 by 90%. The iota-carrageenan concentration of the saliva samples was analyzed by UV-Vis spectroscopy. The antiviral effectiveness of the individual saliva samples was determined in vitro against a panel of respiratory viruses including hRV1a, hRV8, human coronavirus OC43, influenza virus A H1N1pdm09, coxsackievirus A10, parainfluenza virus 3 and SARS-CoV-2 using standard virological assays.
The mean iota-carrageenan concentration detected in the saliva exceeds the concentration needed to inhibit 90% of hRV1a and hRV8 replication by 134-fold (95% CI 116.3-160.8-fold; p < 0.001). Thus, the study met the primary endpoint. Furthermore, the iota-carrageenan saliva concentration was 60 to 30,351-fold higher than needed to reduce viral replication/binding of all tested viruses by at least 90% (p < 0.001). The effect was most pronounced in hCoV OC43; in case of SARS-CoV-2, the IC was exceeded by 121-fold (p < 0.001).
Sucking an iota-carrageenan containing lozenge releases sufficient iota-carrageenan to neutralize and inactivate the most abundant respiratory viruses as well as pandemic SARS-CoV-2. The lozenges are therefore an appropriate measure to reduce the viral load at the site of infection, hereby presumably limiting transmission within a population as well as translocation to the lower respiratory tract.
NCT04533906.
本研究旨在调查含ι-卡拉胶的含片在健康受试者口中含服时，能否释放足够量的ι-卡拉胶至唾液中，以中和引起普通感冒的最常见呼吸道病毒家族的代表毒株以及新型冠状病毒。
在这项单中心、开放标签、前瞻性临床试验中，纳入31名健康受试者，让他们含服一种市售的含ι-卡拉胶含片。收集27名受试者的唾液样本用于体外疗效分析。本研究的主要目的是评估唾液样本中ι-卡拉胶的平均浓度是否超过5μg/mL，这是已知能使人类鼻病毒（hRV）1a和8的复制减少90%的浓度。通过紫外可见光谱法分析唾液样本中ι-卡拉胶的浓度。使用标准病毒学检测方法，在体外测定各个唾液样本对一组呼吸道病毒的抗病毒效力，这些病毒包括hRV1a、hRV8、人冠状病毒OC43、甲型H1N1pdm09流感病毒、柯萨奇病毒A10、副流感病毒3和新型冠状病毒。
唾液中检测到的ι-卡拉胶平均浓度比抑制90%的hRV1a和hRV8复制所需的浓度高出134倍（95%置信区间为116.3 - 160.8倍；p < 0.001）。因此，本研究达到了主要终点。此外，唾液中ι-卡拉胶的浓度比将所有测试病毒的复制/结合减少至少90%所需的浓度高60至30351倍（p < 0.001）。这种效果在人冠状病毒OC43中最为明显；对于新型冠状病毒，该浓度超过抑制浓度121倍（p < 0.001）。
含服含ι-卡拉胶的含片可释放足够的ι-卡拉胶，以中和并灭活最常见的呼吸道病毒以及大流行的新型冠状病毒。因此，含片是一种合适的措施，可降低感染部位的病毒载量，从而可能限制人群内的传播以及病毒向下呼吸道的转移。
NCT04533906。
