Topical Antibacterial Agents for Prevention of COVID-19

2000032248

The primary objective of this study is to determine whether intranasal application of aminoglycoside (Neosporin) increases local nasal innate immune responses compared to placebo control in healthy participants.

2022-09-01

2023-09-22

2023-09-22

Completed

Early phase I

67

Inclusion Criteria: * Completion of written informed consent * Covid-negative within 48 hours of enrollment based on PCR or Antigen test. If subjects are found to be positive, the PI will recommend appropriate follow-ups. * In good general health as evidenced by medical history * Ability to take Nasal medication and be willing to adhere to the nasal agent regimen Exclusion Criteria: * Participant with active nasal or respiratory symptoms. * Participant with active or chronic respiratory nasal or respiratory infections and or is currently on antibiotics * Participant who has been treated with oral or topical antibiotics with the past 14 days * Participant who is on intranasal or oral corticosteroids or systemic immunosuppression medication * Participant who has immunocompromised conditions such as rheumatological diseases, HIV, cancer on chemotherapy or biologic therapies. * Participant who is on any intranasally applied medications (prescription or over the counter) including nonmedical nasal products and the use of Netipot or other nasal flush products. * Participant with known allergic history to Neosporin (allergic history to neomycin or bacitracin or polymyxcin or pramoxine or the inactive ingredients that include cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate and white petrolatum) * Participant with known allergies to aminoglycoside antibiotics (neomycin, tobramycin, gentamycin, others) * Participant with history of COVID-19 infection in the past 8 weeks. * Participant who is pregnant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Run-in cohort to test optimal sampling and storage conditions: For 6 participants, the investigator will test 50:50 with Neosporin vs Placebo participant nasal sampling and shipping protocol to evaluate signal to noise of interferon-stimulated genes (ISG) measures. If needed, we will rerun the power calculations.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Blinding will be achieved by masking and packaging the products in an identical fashion. Investigational product will be filled in empty Aluminum Ointment Tubes 15 g (Supplied via HealthCareLogistics, Item # 10201-01). The empty Aluminum Ointment Tubes are sterilized by gamma irradiation and have protective inner (epoxy phenolic) coating to prevent ointments from sticking to the sides and reacting with the aluminum.\n\nEach tube will be filled with approximately 15 g of the Neosporin ointment investigational product, or Vaseline Petroleum Jelly its matching placebo, and labeled in a blinded fashion.\n\nPatient or clinicians requesting unblinding will contact the principal investigator (PI).', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}

2023-10-03