ABSTRACT
Aim: In a population profile corrected for sociodemographic factors, the aim of this study was to examine sociodemographic the protective effect of a phthalocyanine-derived mouthwash (APD) before infection with SARS-CoV-2, in addition to analyzing the survival of the at-risk population and the confirmed diagnosis of COVID-19. Methods: For individuals from the Uru municipality, a structured questionnaire consisting of two parts was completed before the distribution of APD. Subsequently, subjects received two bottles containing 600 mL of APD and were instructed to rinse/gargle with 3 mL of the solution 3 to 5 times per day for 1 min for 2 months. Data were obtained from the electronic system of the municipal health center, organized in a spreadsheet, and analyzed using multiple linear regression and Cox regression analysis. Results: The study included 995 participants with the following sociodemographic data: 98/995 individuals (p<0.002) who did not complete high school used the APD 66.30 times more than did individuals with higher education. The results in terms of survival were meaningful in relation to the duration of APD use. The protective factor for COVID-19 was 14.1%. Conclusion: Daily use of a solution containing phthalocyanine derivatives provided a higher protection factor against COVID-19 infection, predominantly in individuals without a school-completion certificate.
ABSTRACT
Aim: The aim of this randomised, double-blind, placebo-controlled pilot clinical trial is to evaluate the capacity of a mouthwash to reduce SARS-CoV-2 viral load in the saliva of patients with COVID-19. Methods: Twenty-three symptomatic SARS-CoV-2-positive outpatients were selected andrandomised into two groups and registered at NTC 04563689. Both groups rinsed and gargled for one minute with either distilled water (Placebo) or with 0.05% Cetylpyridinium chloride (CPC) plus 0.12% Chlorhexidine (CHX) mouthwash (PERIOAID Intensive Careï). Saliva samples were collected before the use of placebo or mouthwash and after 15 minutes and 1 and 2 hours of either of the above treatment. A saliva sample was also taken five days after regular use of placebo or mouthwash twice daily. The virus was detected by qRT-PCR. Results: A great heterogeneity in the viral load values was observed at baseline in both groups for nasopharyngeal and saliva samples. Most of the patients who used the mouthwash (8/12) had a significant decrease in baseline viral load after 15 min (greater than 99% reduction). This inhibitory effect was maintained for up to two hours in 10 of the 12 patients. At five days, SARS-CoV-2 RNA was detectedin only 1 patient from the mouthwash group and in 5 from the placebo group. Conclusions: This study points out that a CPC mouthwash can reduce the viral load in saliva of COVID-positive patients. This finding may be important in transmission control of SARS-CoV-2. Nevertheless, the clinical relevance of CPC mouthwash-reduction on SARS-CoV-2 shedding in saliva requires further study.
Objetivo: El objetivo de este ensayo clínico piloto aleatorizado, doble ciego y controlado con placebo es evaluar la capacidad de un enjuague bucal para reducir la carga viral del SARS-CoV-2 en la saliva de pacientes con COVID-19. Materiales y métodos:Veintitrés pacientes ambulatorios positivos para SARS-CoV-2 sintomáticos fueron seleccionados y aleatorizados en dos grupos y registrados en el NTC 04563689. Ambos grupos se enjuagaron y hicieron gárgaras durante un minuto con agua destilada (placebo) o con cloruro decetilpiridinio al 0 ,05 % (CPC). ) más enjuague bucal con Clorhexidina (CHX) al 0,12% (PERIOAID Intensive Care). Se recolectaron muestras de saliva antes del uso de placebo o enjuague bucal y después de 15 minutos y 1 y 2 horas de cualquiera de los tratamientos anteriores. También se tomó una muestra de saliva cinco días después del uso regular de placebo o enjuague bucal dos veces al día. El virus fue detectado por qRT-PCR. Resultados:Se demostró una gran heterogeneidad en los valores de carga viral al inicio del estudio en grupos ambos para muestras de nasofaringe y saliva. La mayoría de los pacientes que usaron el enjuague bucal (8/12) tuvieron una disminución significativa en la carga viral inicial después de 15 minutos (reducción superior al 99 %). Este efecto inhibidor se mantuvo hasta dos horas en 10 de los 12 pacientes. A los cinco días, se detectó ARN del SARS-CoV-2 en solo 1 paciente del grupo de enjuague bucal y en 5 del grupo de placebo. Conclusiones:Este señala que un enjuague bucal CPC puedereducir la carga viral en saliva de pacientes COVID positivos. Este hallazgo puede ser importante en el control de la transmisión del SARS-CoV-2. Sin embargo, la relevancia clínica de la reducción del enjuague bucal con CPC en la excreción de SARS-CoV-2 en la saliva requiere más estudios.
ABSTRACT
Aim: In this community trial, the objective was to evaluate the incidence of coronavirus disease-2019 (COVID-19) cases in two similar communities in three distinct phases: 1 (before the intervention), 2 (during the intervention), and 3 (after the intervention). Methods: The test community received the oral antiseptic intervention (experimental), while the control community did not. The official information agency ("Statewise System for Data Analysis") provided the number of confirmed COVID-19 cases. Data were analyzed according to the three phases per epidemiological week (epi) using the R Core Team (2021) program. The relative risk and 95% confidence intervals between the cumulative incidence values of the test and control communities were calculated for each period. In the test community, a total of 995 residents over 10 years of age received two bottles containing 600 ml of mouthwash containing antiviral phthalocyanine derivative (APD). The participants were asked to gargle/rinse with of 5 mL of the mouthwash containing ADP 3 to 5 times a day, for 1 min, until the bottles were empty. Results: In phases 1 and 3, the disease risk between the two communities did not differ significantly (p>0.05), while in phase 2, the disease risk was 54% lower in the test community than in the control community. Conclusion: The use of the APD mouthwash protocol seems to reduce the COVID-19 incidence at the population level, and further studies are needed to confirm its protective effect under more precisely controlled conditions.
