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Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial

The risk of contamination and dissemination by SARS-CoV-2 has a strong link with nasal, oral and pharyngeal cavities. Recently, our research group observed the promising performance of an anionic phthalocyanine derivative (APD) used in a mouthwash protocol without photoexcitation; this protocol impr...

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Autores principales: da Silva Santos, Paulo Sérgio, da Fonseca Orcina, Bernardo, Machado, Rafael Rahal Guaragna, Vilhena, Fabiano Vieira, da Costa Alves, Lucas Marques, Zangrando, Mariana Schutzer Ragghianti, de Oliveira, Rodrigo Cardoso, Soares, Mariana Quirino Silveira, Simão, Andréa Name Colado, Pietro, Emilene Cristine Izu Nakamura, Kuroda, Juliana Pescinelli Garcia, de Almeida Benjamim, Ivanilda Aparecida, Araujo, Danielle Bastos, Toma, Sérgio Hiroshi, Flor, Lourival, Araki, Koiti, Durigon, Edison Luiz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497631/
https://www.ncbi.nlm.nih.gov/pubmed/34620904
http://dx.doi.org/10.1038/s41598-021-99013-5
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author da Silva Santos, Paulo Sérgio
da Fonseca Orcina, Bernardo
Machado, Rafael Rahal Guaragna
Vilhena, Fabiano Vieira
da Costa Alves, Lucas Marques
Zangrando, Mariana Schutzer Ragghianti
de Oliveira, Rodrigo Cardoso
Soares, Mariana Quirino Silveira
Simão, Andréa Name Colado
Pietro, Emilene Cristine Izu Nakamura
Kuroda, Juliana Pescinelli Garcia
de Almeida Benjamim, Ivanilda Aparecida
Araujo, Danielle Bastos
Toma, Sérgio Hiroshi
Flor, Lourival
Araki, Koiti
Durigon, Edison Luiz
author_facet da Silva Santos, Paulo Sérgio
da Fonseca Orcina, Bernardo
Machado, Rafael Rahal Guaragna
Vilhena, Fabiano Vieira
da Costa Alves, Lucas Marques
Zangrando, Mariana Schutzer Ragghianti
de Oliveira, Rodrigo Cardoso
Soares, Mariana Quirino Silveira
Simão, Andréa Name Colado
Pietro, Emilene Cristine Izu Nakamura
Kuroda, Juliana Pescinelli Garcia
de Almeida Benjamim, Ivanilda Aparecida
Araujo, Danielle Bastos
Toma, Sérgio Hiroshi
Flor, Lourival
Araki, Koiti
Durigon, Edison Luiz
author_sort da Silva Santos, Paulo Sérgio
collection PubMed
description The risk of contamination and dissemination by SARS-CoV-2 has a strong link with nasal, oral and pharyngeal cavities. Recently, our research group observed the promising performance of an anionic phthalocyanine derivative (APD) used in a mouthwash protocol without photoexcitation; this protocol improved the general clinical condition of patients infected with SARS-CoV-2. The present two-arm study evaluated in vitro the antiviral activity and cytotoxicity of APD. Additionally, a triple-blind randomized controlled trial was conducted with 41 hospitalized patients who tested positive for COVID-19. All the included patients received World Health Organization standard care hospital treatment (non-intensive care) plus active mouthwash (experimental group AM/n = 20) or nonactive mouthwash (control group NAM/n = 21). The adjunct mouthwash intervention protocol used in both groups consisted one-minute gargling/rinsing / 5 times/day until hospital discharge. Groups were compared considering age, number of comorbidities, duration of symptoms prior admission and length of hospital stay (LOS). The associations between group and sex, age range, presence of comorbidities, admission to Intensive care unit (ICU) and death were also evaluated. The in vitro evaluation demonstrated that APD compound was highly effective for reduction of SARS-CoV-2 viral load in the 1.0 mg/mL (99.96%) to 0.125 mg/mL (92.65%) range without causing cytotoxicity. Regarding the clinical trial, the median LOS of the AM group was significantly shortened (4 days) compared with that of the NAM group (7 days) (p = 0.0314). Additionally, gargling/rinsing with APD was very helpful in reducing the severity of symptoms (no ICU care was needed) compared to not gargling/rinsing with APD (28.6% of the patients in the NAM group needed ICU care, and 50% of this ICU subgroup passed way, p = 0.0207). This study indicated that the mechanical action of the protocol involving mouthwash containing a compound with antiviral effects against SARS-CoV-2 may reduce the symptoms of the patients and the spread of infection. The use of APD in a mouthwash as an adjuvant the hospital COVID-19 treatment presented no contraindication and reduced the hospital stay period. Trial registration: The clinical study was registered at REBEC—Brazilian Clinical Trial Register (RBR-58ftdj).
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spelling pubmed-84976312021-10-12 Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial da Silva Santos, Paulo Sérgio da Fonseca Orcina, Bernardo Machado, Rafael Rahal Guaragna Vilhena, Fabiano Vieira da Costa Alves, Lucas Marques Zangrando, Mariana Schutzer Ragghianti de Oliveira, Rodrigo Cardoso Soares, Mariana Quirino Silveira Simão, Andréa Name Colado Pietro, Emilene Cristine Izu Nakamura Kuroda, Juliana Pescinelli Garcia de Almeida Benjamim, Ivanilda Aparecida Araujo, Danielle Bastos Toma, Sérgio Hiroshi Flor, Lourival Araki, Koiti Durigon, Edison Luiz Sci Rep Article The risk of contamination and dissemination by SARS-CoV-2 has a strong link with nasal, oral and pharyngeal cavities. Recently, our research group observed the promising performance of an anionic phthalocyanine derivative (APD) used in a mouthwash protocol without photoexcitation; this protocol improved the general clinical condition of patients infected with SARS-CoV-2. The present two-arm study evaluated in vitro the antiviral activity and cytotoxicity of APD. Additionally, a triple-blind randomized controlled trial was conducted with 41 hospitalized patients who tested positive for COVID-19. All the included patients received World Health Organization standard care hospital treatment (non-intensive care) plus active mouthwash (experimental group AM/n = 20) or nonactive mouthwash (control group NAM/n = 21). The adjunct mouthwash intervention protocol used in both groups consisted one-minute gargling/rinsing / 5 times/day until hospital discharge. Groups were compared considering age, number of comorbidities, duration of symptoms prior admission and length of hospital stay (LOS). The associations between group and sex, age range, presence of comorbidities, admission to Intensive care unit (ICU) and death were also evaluated. The in vitro evaluation demonstrated that APD compound was highly effective for reduction of SARS-CoV-2 viral load in the 1.0 mg/mL (99.96%) to 0.125 mg/mL (92.65%) range without causing cytotoxicity. Regarding the clinical trial, the median LOS of the AM group was significantly shortened (4 days) compared with that of the NAM group (7 days) (p = 0.0314). Additionally, gargling/rinsing with APD was very helpful in reducing the severity of symptoms (no ICU care was needed) compared to not gargling/rinsing with APD (28.6% of the patients in the NAM group needed ICU care, and 50% of this ICU subgroup passed way, p = 0.0207). This study indicated that the mechanical action of the protocol involving mouthwash containing a compound with antiviral effects against SARS-CoV-2 may reduce the symptoms of the patients and the spread of infection. The use of APD in a mouthwash as an adjuvant the hospital COVID-19 treatment presented no contraindication and reduced the hospital stay period. Trial registration: The clinical study was registered at REBEC—Brazilian Clinical Trial Register (RBR-58ftdj). Nature Publishing Group UK 2021-10-07 /pmc/articles/PMC8497631/ /pubmed/34620904 http://dx.doi.org/10.1038/s41598-021-99013-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
da Silva Santos, Paulo Sérgio
da Fonseca Orcina, Bernardo
Machado, Rafael Rahal Guaragna
Vilhena, Fabiano Vieira
da Costa Alves, Lucas Marques
Zangrando, Mariana Schutzer Ragghianti
de Oliveira, Rodrigo Cardoso
Soares, Mariana Quirino Silveira
Simão, Andréa Name Colado
Pietro, Emilene Cristine Izu Nakamura
Kuroda, Juliana Pescinelli Garcia
de Almeida Benjamim, Ivanilda Aparecida
Araujo, Danielle Bastos
Toma, Sérgio Hiroshi
Flor, Lourival
Araki, Koiti
Durigon, Edison Luiz
Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
title Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
title_full Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
title_fullStr Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
title_full_unstemmed Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
title_short Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
title_sort beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for covid-19: randomised trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497631/
https://www.ncbi.nlm.nih.gov/pubmed/34620904
http://dx.doi.org/10.1038/s41598-021-99013-5
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