SARS- CoV-2 or novel coronavirus enters in the human body through the nose and mouth, stays there for a while. Then binds with ACE2 receptor, enters inside the cell, multiply there and manifests. Again, Polyvinyl Pyrrolidone or Povidone Iodine (PVP-I) is a strong microbicidal agent having 99.99% virucidal efficacy in its only 0.23% concentration, irrespective of all known viruses, even in SARS- CoV-2 (in vitro). An oro-nasal spray is designed to apply the PVP-I in the nose and oral cavity to gain a protective layer or coating over nasal and oral mucosa, so that SARS-CoV-2 can’t bind with the ACE-2 receptor and prevent their entry inside. So, it will be effective for the prevention of COVID-19. Moreover, as PVP-I has the ability for the destruction of SARS-CoV-2, the transmission of SARS- CoV-2 from the patient will be reduced also. Thus PVP-I oro-nasal spray can act as an effective shield for COVID-19 protection for healthcare workers, for all.
Coronavirus disease 2019 (COVID-19) has already affected millions of people with more than a million deaths worldwide since the advent of SARS-CoV-2 in late 2019 . SARS- CoV-2 enters in the human body through the nose and mouth, stays there for a while. Then binds with ACE2 receptor, enters inside the cell, multiply there and manifests. Again, it is already established that PVP-I is a strong microbicidal (chemical) agent, having 99.99% virucidal efficacy in its only 0.23% concentration, irrespective of all known viruses, even in SARS-CoV-2 (in vitro).
In lots of articles of scholars from different part of the world, use of PVP-I for intranasal and /or oral application is proposed or recommended, for COVID-19 prevention and for reduction of transmissibility of COVID-19. Several articles of different doctors and scientists recommended for a clinical trial on intranasal or intraoral application of PVP-I.
Here, an effective and safe Oro-Nasal Spray is designed to apply the PVP-I in the nose and oral cavity to gain a protective layer or coating over nasal and oral mucosa, so that SARS-CoV-2 can’t bind with the ACE-2 receptor and prevent their entry inside. Thus it will be effective for the prevention of COVID-19. Moreover, as PVP-I has the ability for the destruction of SARS-CoV-2, the transmission of SARS- CoV-2 will be reduced also.
Nasal drop works on the nasal mucosa, part of the nasopharynx. It passes through the floor of the nose and a large area of the nasopharynx is escaped or not covered. Nasal drops are cleared more quickly from the nose than nasal sprays. Nasal drops are to be used usually in lying-down position. The nasal spray is easier to use as it diffuses better and reaches deeper into the nose. Nasal spray can be used in sitting position as well. PVP-I can be reached in the wide area of the nasopharynx, even furthest area effectively and successfully by using nasal spray. In these context, nasal spray is better than nasal drop for distributing the drug in deeper structure or difficult to reach structure and in nasopharynx.
In Japan, 0.45% PVP-I throat spray is being used since long for prevention of cold and sore throat treatment. Gargling with PVP-I or spraying the throat with PVP-I is encouraged and included in their national respiratory guideline.
Again, PVP-I is being used as mouthwash throughout the world (, specially PVP-I 1% mouthwash in Asia,) since long with safety and good efficacy. PVP-I 0.5% nasal drop or nasal spray is being proposed in multiple scientific articles.
After getting positive or significant result ( yet not published) from a clinical trial of ‘’ Virucidal efficacy of PVP-I on SARS- CoV-2 in the nasopharynx (NCT04549376), I am proposing 0.6% PVP-I Oro-Nasal spray is to be used as protective measures. In that trial, among 189 patients 0.6% PVP-I nasal spray showed better efficacy (,i.e. about 81.5%) than other (0.4%, 0.5% PVP-I nasal spray) with almost no mucosal irritation.
I proposed (made and started using) an Oro-Nasal Spray, which can be used in the nose as well as the throat. It’s nothing but 0.6% PVP-I solution, kept in a simple nasal spray device. To prevent COVID-19 transmission from patient to HCW, HCW (asymptomatic carrier) to common people, or patients of other diseases, this proposed oro-nasal spray will definitely be helpful.
Safety of PVP-I Oro-Nasal spray
Oral PVP-I gargle, throat spray, nasal spray formulations are currently available as over-the-counter medications in many countries, including Japan and Canada. PVP-I in low concentrations has not been known to stain teeth or to cause any major adverse effect. PVP-I oronasal spray should better to avoid in patients with iodine allergy or those undergoing radioiodine treatment or thyroid dysfunction. In a study PVP-I is proved ciliotoxic in concentrations of 5% and 10%, but not in proposed low concentration 8.
The topical application of iodine (in low concentration) intranasally for the treatment of recalcitrant chronic rhinosinusitis has been described by the St. Paul’s Sinus Centre team in Vancouver. They found it was beneficial for the management of this condition, but also did not lead to any significant effect on thyroid function, mucociliary clearance or olfaction.
In a study conducted by Gluck et al. three groups received liposomal dispersion with PVP-I (2.2, 4.4 and 0% as control) in single and repeated use. Application of liposomal PVP-I spray to the nasal mucosa does not result in any demonstrable limitation of the nasal function nor in detectable damage to the multilayer ciliated epithelium of the nose. Improvement of various parameters of nasal function under liposomal PVP-I suggest improved mucociliary clearance. Explanation could be humidification, improved surfactant (phospholipid) level and/or sufficient mucolytic activity of iodide due to local application of the constituents. So 0.6% PVP-I Oro-Nasal spray is safe for long time use.
Proposed prophylactic treatment
Prior to the induction of anesthesia, each patient self-administers PVP-I as follows:
15 ml 1% PVP-I as a swish and spit for 30 s
The protocol recommendation above could potentially also be applied in a clinic setting, where aerosol-generating procedures are frequently performed.
After general anesthesia has been induced,
1% PVP-I solution is applied to oral cavity, oropharynx, hypopharynx and laryngopharynx surfaces (for all transoral procedures or other procedures that cross these mucosal surfaces)
10–20 ml 1% PVP-solution is placed into the nasal cavity (for any transnasal procedure).
Mucosal contact of the PVP-I solution is maintained for 30 s.
The rationale for using 1% PVP-I solution and 30 s mucosal contact time was determined on the basis of widespread over the counter availability and recommended instructions on usage of 1% PVP-I gargle and mouth wash in countries around the world.
** NOTE **
Oral PVP-I gargle formulations are currently available as over-the-counter medications in many countries, including Japan and Canada. Rare cases of aspiration pneumonitis as well as thyroid dysfunction have been reported as side effects to povidone-iodine. Cases of anaphylaxis, contact dermatitis and edema after exposure have also been reported. Ingestion in high concentrations or quantities may lead to acute kidney injury and/or liver toxicity. PVP-I in low concentrations has not been known to stain teeth . Topical oro-nasal PVP-I prophylaxis should not be considered in patients with iodine allergy or those undergoing radioiodine treatment. In a study of PVP-I oral gargle for cancer-associated oral mucositis, no mucosal irritation was reported. Of note, studies have shown that PVP-I is ciliotoxic in concentrations of 5% and 10%.