The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level. In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.
Hypochlorous acid (HClO) is a powerful antimicrobial and antiviral used for the control of
various infections, repair and washing of surgical wounds, as well as for disinfection of
surfaces. In vivo, it is synthesized by the cells of the immune system for the control of
pathogens during phagocytosis and has been synthesized and stabilized for use in different
entities.
The therapeutic uses of HClO began in the First World War with the studies of Alexis Carrel
and Henry Dakin who obtained a buffered sodium hypochlorite solution (Dakin's solution) which
generated ideal concentrations of HClO, using it successfully in washing and treatment of
wounds without presenting any damage or undesired effect on the patient's tissues. In 1993,
the HClO molecule was stabilized, popularizing its use for the control of predominantly skin
infections, treatment of chronic ulcers, closure and cleaning of wounds, management of burned
patients, and disinfection of surfaces.
Biologically, it is part of the reactive oxygen species (ROS) synthesized by cells of the
immune system (Neutrophils and Macrophages) during an immunological process known as
"respiratory burst", during phagocytosis of antigens in reaction with the enzyme
myeloperoxidase (MPO), hydrogen peroxide (H2O2) and a chlorine ion. Safety profiles in in
vivo models have driven our initiative to use Stabilized Hypochlorous Acid (S-HClO), as an
early therapeutic option in patients with SARS-Cov-2 infection or in close contact with
COVID-193 positive patients.
Calderon et al and carried out the evaluation of the antimicrobial effect of HClO on
potentially pathogenic microorganisms of the oral cavity. The study reports that hypochlorous
acid achieved bacterial inhibition of 99.9% at a concentration of 0.05% and a pH of 5.2 per
minute of action for different types of bacteria and for infectious microorganisms.
Virological tests have also been performed on feline calcivirus (Ebola-like virus),
rotavirus, AH1N1, adenovirus and SARS, found to be highly effective after 1 minute of
application.
In the face of the COVID-19 pandemic, effective and early treatments are being sought to help
prevent the dissipation of the virus (disinfection of surfaces), to neutralize the virus at
an early stage when it is lodged in the upper respiratory tract and nose, since this is the
Probable route of infection of the ethmoid lamina and later causing viral encephalopathy and
treatment of patients with bronchial infection by this virus, decreasing the viral load and
causing destruction of the virus. There are reports of the use of HClO in the nasal mucosa in
studies in humans, reporting safety and effectiveness, both in adults and in children, which
leads us to propose the application of said nasal spray solution, as a prophylaxis in health
personnel with a high risk of infection by SARS-CoV-2.
A RCT with the use S-HClO as a prevention treatment for the infection by SARS-CoV-2 in health
professionals is proposed.
Drug: Stabilized hypochlorous acid
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
Drug: Placebo
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
Inclusion Criteria:
- Specialist physicians, resident physicians, medical students, and nursing personnel
who work at the San Ignacio University Hospital.
- Subjects of any sex over 18 years of age who work as health care personnel, in care
services that care for patients with a suspected or confirmed diagnosis of COVID-19
and who are active during the study recruitment.
- That they have not presented general symptoms such as malaise, fever, cough, dyspnea
or muscle pain during the last 7 days.
- Subjects negative to the antigen test for COVID-19.
Exclusion Criteria:
- Subjects considered as a resolved case of COVID-19 infection, according to guidelines
from the Colombian National Institute of Health.
- Health personnel with social distancing due to close contact without personal
protective equipment with patients confirmed to be infected or taking any medication
as a possible prophylaxis for COVID-19 (example: chloroquine, hydroxychloroquine,
azithromycin)
- Health workers who have permits or temporary withdrawal from their hospital work for
more than one week during the month of the study.
- Some type of allergy to chlorinated agents or hypersensitivity to HClO
- Known diagnosis of upper airway respiratory disease where COVID-19 such as the common
cold, sinusitis, pharyngitis, laryngotracheitis and epiglottitis or lower such as
bronchiolitis, pneumonia, and mixed conditions have been ruled out.
- Previous COVID19 infection determined by positive PCR or positive serum antibody
titers.
- Any condition that in the principal investigator's discretion renders the subject
ineligible to participate in the study.
Juan Zambrano, MD. M.Sc., Principal Investigator
Hospital Universitario San Ignacio/Pontificia Universidad Javeriana