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

NCT04684550 | Withdrawn Phase 2

• 1 other identifier: FM-CIE-0824-20
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

SARS-CoV Infection; Covid19; Infection Viral

Keywords

SARS-CoV Infection; Stabilized hypochlorous acid (S-HClO); Prophylaxis; Health Professionals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse drug reaction (ADR)

  Through study completion, an average of 6 months

• Seroconversion

  Through study completion, an average of 6 months

• Hospitalization

  Through study completion, an average of 6 months

• ICU

  Through study completion, an average of 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Health personnel who work in places of greater risk (hospitals and primary level consultation) with conventional protection elements added to the application of 2 nasal puff every 8 hours of a nasal spray containing 0.9% SSN (placebo) and gargles (SSN 0.9%).

Drug: Placebo

Experimental

EXPERIMENTAL

Health personnel who work in higher risk places (hospitals and primary level consultation) with conventional protection elements added to the application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).

Drug: Stabilized hypochlorous acid

Interventions

Stabilized hypochlorous acid DRUG

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

Experimental

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Related Publications (8)

• 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.

  PMID: 20674795 BACKGROUND

• 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.

  PMID: 32052514 BACKGROUND

• 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.

  PMID: 31904191 BACKGROUND

• 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.

  PMID: 25421399 BACKGROUND

• 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.

  PMID: 24770639 BACKGROUND

• 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.

  PMID: 29279579 BACKGROUND

• 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.

  PMID: 20475674 BACKGROUND

• 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.

  PMID: 27853946 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Juan Zambrano, MD. M.Sc.

  Hospital Universitario San Ignacio/Pontificia Universidad Javeriana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: * The first group of health personnel who work in places of greater risk (hospitals and primary level consultation) with conventional protection elements added to the application of 2 nasal puff every 8 hours of a nasal spray containing 0.9% SSN (placebo) and gargles (SSN 0.9%). * A second group of health personnel who work in higher risk places (hospitals and primary level consultation) with conventional protection elements added to the application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-masked, placebo-controlled clinical experiment is proposed.

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: February 15, 2021
• Primary Completion: June 15, 2021
• Study Completion: August 15, 2021
• Last Updated: March 3, 2023

Record last verified: 2023-03