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All Studies   Meta Analysis    Recent:   

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

da Silva Santos et al., Scientific Reports, doi:10.1038/s41598-021-99013-5
Oct 2021  
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Mortality 85% Improvement Relative Risk ICU admission 92% Discharge 54% Phthalocyanine  da Silva Santos et al.  LATE TREATMENT  DB RCT Is late treatment with phthalocyanine beneficial for COVID-19? Double-blind RCT 41 patients in Brazil (August - November 2020) Lower ICU admission (p=0.021) and hospitalization (p=0.031) c19early.org da Silva Santos et al., Scientific Rep.., Oct 2021 Favorsphthalocyanine Favorscontrol 0 0.5 1 1.5 2+
31st 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.
4,400+ studies for 79 treatments. c19early.org
RCT 41 patients in Brazil, 20 treated with a phthalocyanine derivative mouthwash, showing shorter hosptalization and lower ICU admission with treatment. One minute gargling/rinsing 5 times per day.
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 (early treatment may be more beneficial).
risk of death, 85.4% lower, RR 0.15, p = 0.23, treatment 0 of 20 (0.0%), control 3 of 21 (14.3%), NNT 7.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 92.1% lower, RR 0.08, p = 0.02, treatment 0 of 20 (0.0%), control 6 of 21 (28.6%), NNT 3.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
discharge, 53.7% lower, HR 0.46, p = 0.03, treatment 20, control 21, inverted to make HR<1 favor treatment, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
da Silva Santos et al., 7 Oct 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 17 authors, study period 10 August, 2020 - 4 November, 2020. Contact: paulosss@fob.usp.br.
This PaperPhthalocyanineAll
Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial
Paulo Sérgio Da Silva Santos, Bernardo Da Fonseca Orcina, Rafael Rahal Guaragna Machado, Fabiano Vieira Vilhena, Lucas Marques Da Costa Alves, Mariana Schutzer Ragghianti Zangrando, Rodrigo Cardoso De Oliveira, Mariana Quirino Silveira Soares, Andréa Name Colado Simão, Emilene Cristine Izu Nakamura Pietro, Juliana Pescinelli Garcia Kuroda, Ivanilda Aparecida De Almeida Benjamim, Danielle Bastos Araujo, Sérgio Hiroshi Toma, Lourival Flor, Koiti Araki, Edison Luiz Durigon
Scientific Reports, doi:10.1038/s41598-021-99013-5
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
Author contributions Competing interests The authors declare no competing interests.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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