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

FM-CIE-0824-20

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.

2021-02-15

2021-06-15

2021-08-15

Withdrawn

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-masked, placebo-controlled clinical experiment is proposed.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '* 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%).\n* 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).', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-03-03