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

Abstract

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).

Virucidal Activity of Different Mouthwashes Using a Novel Biochemical Assay

“…A randomized clinical trial found that mouthwash containing CPC + Zinc and CHX resulted in substantial reduction of the SARS-CoV-2 viral load in saliva for up to 60 min after rinsing, whereas mouthwash with hydrogen peroxide (HP) resulted in a significant reduction for up to 30 min [ 41 ]. According to a study using an anionic phthalocyanine derivative (APD) in a mouthwash protocol, the mechanical action of the mouthwash containing a chemical with antiviral activity against SARS-CoV-2 may minimize patient symptoms and virus spread [ 42 ].…”

Population-based virucidal phthalocyanine gargle/rinse protocol to reduce the risk of coronavirus disease-2019: a community trial

“…[18][19][20][21] Since saliva was an important source of virus transmission during the pandemic, protective measures, such as the use of antiseptic gargles were adopted and recommended by several countries and organizations against SARS-CoV-2. 5,10,[21][22][23] Some studies have shown that the use of a mouthwash containing APD can reduce the viral load of SARS-CoV-2, acting as a therapeutic aid in reducing the severity and risk of COVID-19 transmission. 8-9, 22-24 These data corroborate the ndings of the present study.…”

A path-based analysis of infected cell line and COVID-19 patient transcriptome reveals novel potential targets and drugs against SARS-CoV-2

“…(94) and conivaptan targets viral non-structural protein 9 (Nsp9) (95). Phthalocyanine has been shown to be effective against preventing covid-19 in randomized trials (96). Bemcentinib has been shown to be effective against SC2 (97) and is being tested (trial NCT04890509) for efficacy in hospitalized covid-19 patients.…”