Use of Hypochlorous Acid as Prophylaxis in Health Personnel at High Risk of Infection by SARS-CoV 2 (COVID19)

Covid19 Clinical Trial

Official title:

Randomized Controlled Clinical Study (RCT) Phase 3 of the Safety and Efficacy of Hypochlorous Acid in the Prophylaxis of Healthcare Personnel at High Risk of Infection by SARS-CoV2 (COVID19) Versus Placebo

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04684550
• Other study ID #: FM-CIE-0824-20
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: February 15, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: March 2023
• Source: Hospital Universitario San Ignacio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infection Viral
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Virus Diseases

Intervention

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).
• Placebo
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario San Ignacio	Pontificia Universidad Javeriana

References & Publications (8)

Edward DG, Lidwell OM. Studies on air-borne virus infections: III. The killing of aerial suspensions of influenza virus by hypochlorous acid. J Hyg (Lond). 1943 Sep;43(3):196-200. doi: 10.1017/s002217240001281x. No abstract available. — View Citation

Gold MH, Andriessen A, Bhatia AC, Bitter P Jr, Chilukuri S, Cohen JL, Robb CW. Topical stabilized hypochlorous acid: The future gold standard for wound care and scar management in dermatologic and plastic surgery procedures. J Cosmet Dermatol. 2020 Feb;19(2):270-277. doi: 10.1111/jocd.13280. Epub 2020 Jan 6. — View Citation

Hakim H, Thammakarn C, Suguro A, Ishida Y, Kawamura A, Tamura M, Satoh K, Tsujimura M, Hasegawa T, Takehara K. Evaluation of sprayed hypochlorous acid solutions for their virucidal activity against avian influenza virus through in vitro experiments. J Vet Med Sci. 2015 Feb;77(2):211-5. doi: 10.1292/jvms.14-0413. Epub 2014 Nov 24. — View Citation

Hui DS, Chan PK. Severe acute respiratory syndrome and coronavirus. Infect Dis Clin North Am. 2010 Sep;24(3):619-38. doi: 10.1016/j.idc.2010.04.009. — View Citation

Ishihara M, Murakami K, Fukuda K, Nakamura S, Kuwabara M, Hattori H, Fujita M, Kiyosawa T, Yokoe H. Stability of Weakly Acidic Hypochlorous Acid Solution with Microbicidal Activity. Biocontrol Sci. 2017;22(4):223-227. doi: 10.4265/bio.22.223. — View Citation

Taharaguchi M, Takimoto K, Zamoto-Niikura A, Yamada YK. Effect of weak acid hypochlorous solution on selected viruses and bacteria of laboratory rodents. Exp Anim. 2014;63(2):141-7. doi: 10.1538/expanim.63.141. — View Citation

Velavan TP, Meyer CG. The COVID-19 epidemic. Trop Med Int Health. 2020 Mar;25(3):278-280. doi: 10.1111/tmi.13383. Epub 2020 Feb 16. No abstract available. — View Citation

Yu MS, Kim BH, Kang SH, Lim DJ. Low-concentration hypochlorous acid nasal irrigation for chronic sinonasal symptoms: a prospective randomized placebo-controlled study. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1527-1533. doi: 10.1007/s00405-016-4387-5. Epub 2016 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of infection by COVID19	Number of participants who get COVID19 infection during the application of S-HClO	Through study completion, an average of 6 months
Secondary	Adverse drug reaction (ADR)	Determine the occurrence of ADR by the use of S-HClO	Through study completion, an average of 6 months
Secondary	Seroconversion	Determine the frequency of seroconversion due to COVID 19	Through study completion, an average of 6 months
Secondary	Hospitalization	Number of participants who fell ill from COVID-19 and was not hospitalized	Through study completion, an average of 6 months
Secondary	ICU	Number of participants who fell ill from COVID-19 and was hospitalized in ICU	Through study completion, an average of 6 months