Randomized Clinical Study Shows That Mouthwash Containing The Antiviral Phthalocyanine Derivative Shortens COVID-19 Hospitalizations

COVID-19 Prophylactics and Therapeutics: It interesting that in the initial stages of the pandemic when mouthwashes containing certain bioactive ingredients and antivirals were proposed as prophylactics or therapeutics alongside other regiments, the mention of mouthwashes for COVID-19 were immediately deemed as fake news by certain bastard journalist, fact-checkers and even so-called experts and doctors. Many were predominantly white western females and also Indians from India who claimed to be either scientific writers or experts but in reality, were just simply garbage! The same can be said of many stupid doctors who only had limited training but did not have a macro or even micro perspective of the COVID-19 disease.(Some readers might not like the name-calling , but enough is enough and its time start the witch hunt and punish those that have been trying to control the COVID-19 narratives from day one with garbage!)

 
To date, a few studies have already been published in various peer reviewed journals showing the benefits of mouthwashes containing certain ingredients when dealing with the COVID-19 disease.
 
In the latest study, Brazilian researchers from the University of São Paulo, Hospital Estadual de Bauru, Instituto de Pesquisa São Leopoldo Mandic and Londrina State University have in a new triple-blind randomized controlled clinical trial found that mouthwashes containing the antiviral phthalocyanine derivative shortens the hospitalization stays of infected COVID-19 patients.
 
The two-arm study evaluated in vitro the antiviral activity and cytotoxicity of anionic phthalocyanine derivative (APD) in mouthwashes. 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).
 
Importantly the 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.
 
The study findings were published in the peer reviewed journal: Scientific Reports. https://www.nature.com/articles/s41598-021-99013-5
 
The study findings showed how antiviral anionic phthalocyanine derivative used in a mouthwash protocol may not only reduce the symptoms of coronavirus disease (COVID-19), but also hamper the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
 
To date, hand washing, mask usage and social distancing were shown to be somewhat effective measures in our fight against the COVID-19 pandemic. But considering that SARS-CoV-2 dissemination shows a strong association with the mouth, antiseptic mouthwashes have been suggested as an extra preventive step against the disease.
 
Phthalocyanines have shown good inactivation properties against different microbial pathogens, and their potential in various biological and medical applications has been recognized.
https://www.hindawi.com/journals/ac/2018/2598062/

Some studies have already hinted that promising activity of anionic phthalocyanine derivative in a mouthwash protocol against SARS-CoV-2.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899311/

https://www.researchgate.net/profile/Paulo-Santos-43/publication/348133755_Oral_Manifestation_COVID-19_and_the_Rapid_Resolution_of_Symptoms_Post-Phtalox_Treatment_a_Case_Series/links/5fef67c592851c13fedbea07/Oral-Manifestation-COVID-19-and-the-Rapid-Resolution-of-Symptoms-Post-Phtalox-Treatment-a-Case-Series.pdf

The present study team lead by Dr Paulo Sérgio da Silva Santos from the Bauru School of Dentistry of the University of São Paulo went one step further, as it aimed to appraise the antiviral activity and cytotoxicity of anionic phthalocyanine derivative in laboratory conditions, but also to clinically assess its use in hospitalized patients with COVID-19.
 
The COVID-19 Prophylactics and Therapeutics study team first evaluated antiviral activity and cytotoxicity of anionic phthalocyanine derivative in vitro.
 
They then conducted a randomized controlled trial with a total of 41 hospitalized patients positive for COVID-19.
 
For the clinical trial, all patients received standard care hospital treatment (non-intensive care) as recommended by the World Health Organization (WHO), together with either an active mouthwash (experimental group of 20 patients) or non-active mouthwash (control group of 21 patients).
 
The mouthwash intervention that was used in both patient groups comprised one minute of gargling and rinsing, five times per day until they were discharged from the hospital. Groups were then compared in respect to their age, symptom burden and duration before admission, number of present comorbidities, and the length of hospital stay.
 
The associations between group and age range, sex, comorbidity burden, admission to the intensive care unit and death had also been evaluated in detail. The study was considered triple-blind, as the patients, the examiner and the statistician were all blinded to the treatment groups.
 
The laboratory evaluation had revealed that anionic phthalocyanine derivative compound was extremely effective in reducing SARS-CoV-2 viral load in the 1.0 mg/mL (99.96%) to 0.125 mg/mL (92.65%) range without causing cytotoxicity. In other words, its antiviral efficacy in vitro has been confirmed.
 
With regards to the clinical trial, the median length of stay for the active mouthwash group was four days, which was significantly shorter when compared to the non-active group (four vs. seven days).
 
In addition, gargling and rinsing with the mouthwash was somewhat helpful in reducing the severity of symptoms and the need for intensive care.
 
Importantly it should be noted that according to the safety outcomes, no side effects have been reported by the patients from both study groups. And even though COVID-19 distribution patterns may vary country-wise in different hospitals, there have been no significant changes when comparing experimental and control groups in terms of sex, comorbidities, or symptom duration prior to hospitalization.
 
The trial findings clearly showed that the mechanical action of the protocol that involves the mouthwash containing a compound with very specific antiviral effects against SARS-CoV-2 might reduce the symptoms of the patients and the subsequent spread of the virus.
 
Dr Paulo Sérgio da Silva Santos from the Bauru School of Dentistry of University of São Paulo told Thailand Medical News, “The outstanding results achieved in the active mouthwash group suggest that mouthwash in addition to other medications can be useful in the strategic planning of COVID-19 treatment by the World Health Organization.”
 
The study team did note that disease dynamics, the healthcare environment, medications, pandemic stress, and sample size may represent possible study limitations. Hence, the interpretation and result generalizability should be performed with reservation, and further studies will be needed to contextualize these results in larger populations.

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