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Use of mouthwash and dentifrice containing antimicrobial phthalocyanine derivative for the reduction of clinical symptoms of COVID-19: A randomized triple-blinded clinical trial

Poleti et al., Journal of Evidence-Based Dental Practice, doi:10.1016/j.jebdp.2022.101777 (date from preprint), RBR-8x8g36
Dec 2021  
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Recovery, day 7 29% Improvement Relative Risk Recovery, day 3 22% Recovery, day 7, dyspnea 46% Recovery, day 3, dyspnea 32% Phthalocyanine  Poleti et al.  EARLY TREATMENT  DB RCT Is early treatment with phthalocyanine beneficial for COVID-19? Double-blind RCT 134 patients in Brazil (November - November 2020) Improved recovery with phthalocyanine (p=0.021) c19early.org Poleti et al., J. Evidence-Based Denta.., Dec 2021 Favorsphthalocyanine Favorscontrol 0 0.5 1 1.5 2+
30th treatment shown to reduce risk in December 2021
 
*, now with p = 0.00019 from 4 studies.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19early.org
RCT 500 patients in Brazil, showing improved recovery with a phthalocyanine derivative mouthwash and toothpaste. Toothbrushing for 2 minutes, three times per day, and gargling/rising (5ml) for one minute, three times a day, for 7 days.
3 studies use direct respiratory tract administration1-3
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
risk of no recovery, 29.1% lower, RR 0.71, p = 0.02, treatment 29 of 59 (49.2%), control 52 of 75 (69.3%), NNT 5.0, day 7.
risk of no recovery, 22.1% lower, RR 0.78, p = 0.02, treatment 38 of 59 (64.4%), control 62 of 75 (82.7%), NNT 5.5, day 3.
risk of no recovery, 45.5% lower, RR 0.54, p = 0.04, treatment 12 of 59 (20.3%), control 28 of 75 (37.3%), NNT 5.9, day 7, dyspnea.
risk of no recovery, 32.5% lower, RR 0.68, p = 0.11, treatment 17 of 59 (28.8%), control 32 of 75 (42.7%), NNT 7.2, day 3, dyspnea.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Poleti et al., 8 Dec 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 10 authors, study period 6 November, 2020 - 19 November, 2020, trial RBR-8x8g36. Contact: marcelo_poleti@yahoo.com.br.
This PaperPhthalocyanineAll
USE OF MOUTHWASH AND DENTIFRICE CONTAINING AN ANTIMICROBIAL PHTHALOCYANINE DERIVATIVE FOR THE REDUCTION OF CLINICAL SYMPTOMS OF COVID-19: A RANDOMIZED TRIPLE-BLIND CLINICAL TRIAL
Marcelo Lupion Poleti, Danielle Gregório, Alisson Gabriel Idelfonso Bistaffa, Karen Barros Parron Fernandes, Fabiano Vieira Vilhena, Paulo Sérgio Da Silva Santos, Andréa Name Colado Simão, Marcell Alysson Batisti Lozovoy, Berenice Tomoko Tatibana, Thais Maria Freire Fernandes
Journal of Evidence-Based Dental Practice, doi:10.1016/j.jebdp.2022.101777
Purpose This clinical trial aimed to evaluate the use of mouthwash and dentifrice containing an antimicrobial phthalocyanine derivative (APD) to reduce the clinical symptoms in patients with COVID-19. Methods This randomized, triple-blind clinical trial enrolled 134 patients aged 18 years or older who underwent COVID-19 testing through the use of nasopharyngeal swab RT-qPCR in a reference center for the diagnosis of COVID-19, had no clinical contraindications to mouthwash and gargle, and had access to cell phones with communication applications. According to the use of a mouthwash and dentifrice containing antimicrobial phthalocyanine derivatives (APD), patients were randomly assigned (1:1) to the APD or non-APD (control) group. All participants were instructed to floss twice a day, brush teeth for 2 minutes 3 times a day, and gargle/rinse (5 mL) for 1 min/3 times a day for 7 days. An online questionnaire was sent to collect data on the clinical symptoms of COVID-19 3 times: T0 (baseline before using the oral hygiene products), T3 (3 days after), and T7 (7 days after). The investigators, patients, and outcome assessors were blinded to group assignment. The Mann-Whitney, Chi -Square, Fisher's exact, and Cochran's tests were used according to the nature of the variables studied, with the level of significance set at P < .05. Results No statistically significant difference was found in the prevalence of symptoms between groups at baseline. A statistically significant reduction in clinical symptoms was found in the control group (fatigue, shortness of breath, hoarse voice,
ACKNOWLEDGMENT The authors gratefully acknowledge the Londrina Municipal Health Authority for their support in this study. CREDIT AUTHOR STATEMENT
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