Efficacy of antiseptic mouthrinses against SARS-CoV-2: A prospective randomized placebo-controlled pilot study

Fantozzi et al., American Journal of Otolaryngology, doi:10.1016/j.amjoto.2022.103549

Jul 2022

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Mouthrinse RCT in Italy comparing short-term viral load after a single 60 second treatment with povidone-iodine, hydrogen peroxide, chlorhexidine, and saline. The greatest efficacy was seen with povidone-iodine, especially for patients with low viral load at baseline.

Analysis of short-term changes in viral load using PCR may not detect effective treatments because PCR is unable to differentiate between intact infectious virus and non-infectious or destroyed virus particles. For example Alemany, Tarragó‐Gil perform RCTs with cetylpyridinium chloride (CPC) mouthwash that show no difference in PCR viral load, however there was significantly increased detection of SARS-CoV-2 nucleocapsid protein, indicating viral lysis. CPC inactivates SARS-CoV-2 by degrading its membrane, exposing the nucleocapsid of the virus. To better estimate changes in viral load and infectivity, methods like viral culture or antigen detection that can differentiate intact vs. degraded virus are preferred.

This study is excluded in the after exclusion results of meta analysis: study only provides short-term viral load results.

1. Alemany et al., Cetylpyridinium Chloride Mouthwash to Reduce Shedding of Infectious SARS-CoV-2: A Double-Blind Randomized Clinical Trial, Journal of Dental Research, doi:10.1177/00220345221102310.sagepub.com, doi.org.

2. Tarragó‐Gil et al., Randomized clinical trial to assess the impact of oral intervention with cetylpyridinium chloride to reduce salivary SARS‐CoV‐2 viral load, Journal of Clinical Periodontology, doi:10.1111/jcpe.13746.wiley.com, doi.org.

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This study includes chlorhexidine, hydrogen peroxide, and povidone-iodine.

relative viral load, 57.5% better, RR 0.43, treatment 8, control 11, T2, relative fraction of median baseline viral load remaining.

relative viral load, 100% better, RR < 0.001, treatment 8, control 11, T1, relative fraction of median baseline viral load remaining.

risk of no viral clearance, 31.2% lower, RR 0.69, p = 0.26, treatment 5 of 8 (62.5%), control 10 of 11 (90.9%), NNT 3.5, T2.

risk of no viral clearance, 58.7% lower, RR 0.41, p = 0.04, treatment 3 of 8 (37.5%), control 10 of 11 (90.9%), NNT 1.9, T1.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Fantozzi et al., 28 Jul 2022, Randomized Controlled Trial, Italy, peer-reviewed, 14 authors, study period December 2020 - May 2021, this trial compares with another treatment - results may be better when compared to placebo.

Contact: umberto.romeo@uniroma1.it.

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This Paper Povidone-Iod..All

Efficacy of antiseptic mouthrinses against SARS-CoV-2: A prospective randomized placebo-controlled pilot study

DDS Paolo Junior Fantozzi, DDS Emanuele Pampena, PhD Alessandra Pierangeli, PhD Giuseppe Oliveto, PhD Leonardo Sorrentino, Domenico Di Vanna, MD d ; Riccardo Pampena, MD e ; Alessandro Lazzaro, MD e ; Elio Gentilini, MD e ; Claudio Maria Mastroianni, MD e ; Gabriella D'ettorre, DDS, MD a ; Antonella Polimeni, DDS a , Umberto Romeo, DDS Alessandro Villa

American Journal of Otolaryngology, doi:10.1016/j.amjoto.2022.103549

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When all antiseptic mouthrinses were considered, PVP-I 1% was found to be more effective in reducing the Ct Values at T1 compared to CHX 0.12% (p=0.001), the H 2 O 2 1% (p=0.027) and the placebo (p=0.001). In addition, PVP-I 1% was found to be more effective in terms of viral load reduction both at T1 (p=0.03) and at T2 (p=0.024) when compared to the placebo. No other statistically significant differences were found amongst the other rinses (Table 3 ). Interestingly, when all the negative patients were considered (at T1 and T2), the median SARS-CoV-2 viral load was 21.5 copies/mL (IQR: 4.9 -294.5), and the median Ct value was 37.8 (IQR: 34.1 -39.8). J o u r n a l P r e -p r o o f Discussion This single-blinded randomized controlled pilot study reported on the efficacy of three oral antiseptics on the reduction of oral SARS-CoV-2 viral load in the oral and oropharyngeal region. PVP-I 1% had the highest efficacy with five patients (62.5%) at T1 and three patients (37.5%) at T2 having undetectable SARS-CoV-2 viral load after the rinse, with an overall median viral load reduction of 19.4 (IQR: 67.3 -8.2) viral loads/mL at T1 (p=0.26), and 33.2 (IQR: 77.6 -5.4) viral loads/mL at T2 (p=0.42). The median Ct value in the PVP-I 1% group at T0 was 36.3 (IQR: 32.0 -38.5), followed by 40.0 (IQR: 29.8 -40.0) at T1 (p=0.002), and 38.8 (IQR: 30.9 -40.0) at T2 (p=0.09). H 2 O 2 1% showed the second highest efficacy, with six patients (54.5%) at T1, and eight patients (72.7%) at T2..

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Late treatment
is less effective

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