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

March 1, 2023 updated by: Hospital Universitario San Ignacio

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
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
Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of infection by COVID19
Time Frame: Through study completion, an average of 6 months
Number of participants who get COVID19 infection during the application of S-HClO
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug reaction (ADR)
Time Frame: Through study completion, an average of 6 months
Determine the occurrence of ADR by the use of S-HClO
Through study completion, an average of 6 months
Seroconversion
Time Frame: Through study completion, an average of 6 months
Determine the frequency of seroconversion due to COVID 19
Through study completion, an average of 6 months
Hospitalization
Time Frame: Through study completion, an average of 6 months
Number of participants who fell ill from COVID-19 and was not hospitalized
Through study completion, an average of 6 months
ICU
Time Frame: Through study completion, an average of 6 months
Number of participants who fell ill from COVID-19 and was hospitalized in ICU
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario San Ignacio

Collaborators

Pontificia Universidad Javeriana

Investigators

  • Principal Investigator: Juan Zambrano, MD. M.Sc., Hospital Universitario San Ignacio/Pontificia Universidad Javeriana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2021

Primary Completion (Anticipated)

June 15, 2021

Study Completion (Anticipated)

August 15, 2021

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM-CIE-0824-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe