Translation of a-t 2022; 53: 78-9
VIRX (other trade names: ENOVID, FABISPRAY): Nasal spray to combat COVID-19?
Several colleagues have drawn our attention to a full-page advertisement for the "anti-Corona nasal spray", VIRX (other trade names: ENOVID and FABISPRAY), in a national daily newspaper (1). The medical device, developed by the Canadian manufacturer SaNOtize, is said to reduce the "risk of infection with COVID-19" by 75%, inactivate viruses within two minutes and reduce the viral load of infected patients by more than 99% within 48 hours (1,2). The duration of a SARS-CoV-2 infection is also said to be "halved" (1,3).**
Two different mechanisms of action are stated for the spray. On the one hand, it is said to block viruses (1,2) via a cellulose derivative that forms a mechanical barrier on the nasal mucosa (3), and on the other hand, it is said to kill viruses (1), apparently through nitric oxide, a gaseous component for which antiviral effects would have been observed in vitro (3,4). However, no conclusions regarding clinical efficacy can be drawn from in-vitro study data (see ALGOVIR; a-t 2020; 51: 80).
A randomised, double-blind, placebo-controlled study (5) conducted in India and primarily investigating the reduction in viral load in 306 adults presenting mild symptoms typical of COVID-19 and a positive antigen test, is used in particular to confirm the efficacy in reducing the duration of infection. However, the study is not considered reliable because of extensive deficiencies in terms of methodology. Over 30% of the randomised subjects were subsequently excluded from the study due to a negative PCR test result and only "high-risk" patients (42% to 45% of the individuals initially randomised) were deemed eligible for the principal analyses (5). The 75% reduction in the risk of infection, as claimed, stems from a retrospective observational study conducted in Thailand (2,3). The latter has not been published and cannot, therefore, be assessed. Furthermore, no benefits can be confirmed on the basis of this study due to its inappropriate design.
Since nitric oxide is presented as effective active principle that allegedly destroys viral integrity (3,5), we do not believe that the spray can be justifiably marketed as a medical device. Just one month ago, the French Medicines Agency, ANSM (French National Agency for the Safety of Medicines and Health Care Products) pointed out that antiviral nasal sprays with an essentially pharmacological effect are to be classified as medicinal products in Europe (6). Upon request, the competent German regional authority informed us that the marketability of the nasal spray as a medical device is currently under investigation (7).
According to the advertisement (8), 25 ml VIRX nasal spray cost €24.80, according to the pharmacy database even €32.99. The supplier claims that the 200 actuations last "approximately 1 month" (8). However, if the spray is used as per the manufacturer's dosing instructions, i.e. twice or three times a day or six times a day following exposure (2 actuations per nostril) (9) it will only last 8 to 25 days.
There is no sound evidence for the benefit of the VIRX nasal spray (other trade names: ENOVID and FABISPRAY) against SARS-CoV-2.
Given the unrealistic efficacy claims, there is the risk that users may be lulled into a false sense of security and will then ignore protective measures such as social distancing and wearing face masks.
We advise against using the spray.
|*||Previous version published on 18 October 2022 as blitz-a-t.|
|**||Alternatively, there is also talk of halving the duration of illness (1).|
|(R = randomised trial)|
|1||Viromed: advertisement for VIRX in Süddeutsche Ztg., 1 Oct. 2022|
|2||Viromed: Press release, Frankfurter Rundschau, 11 Oct. 2022; https://a-turl.de/ceyp|
|3||ZIMMERMANN, J./Viromed: VIRX Whitepaper, undated; https://a-turl.de/e5d9|
|4||SaNOtice: Questions and answers, undated; https://a-turl.de/i5bj|
|R||5||TANDON, M. et al: Lancet Reg. Health Southeast Asia 2022; 3: 100036 (14 pages)|
|6||ANSM: Press release 5 Sept. 2022; https://a-turl.de/mm4z|
|7||Ministerium für Justiz und Gesundheit Schleswig-Holstein: e-mail, 17 Oct. 2022|
|8||Viromed: Online-advertisement for VIRX; https://a-turl.de/tmjj|
|9||SaNOtize: User Guide, undated; https://a-turl.de/6dsx|
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