Topical Antibacterial Agents for Prevention of COVID-19

Yale University

Status and phase: Completed; Phase 1

Conditions: COVID-19; SARS-CoV2 Infection

Treatments: Other: Vaseline; Drug: Neosporin

Study type: Interventional

Funder types: Other

Identifiers

NCT05449392

2000032248

INV-038276 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

This study will evaluate the role of nasally applied neomycin at inducing local antiviral interferon responses that have been associated with protection against SARS-CoV2 ( severe acute respiratory syndrome coronavirus 2). Local interferon immune responses including the nasal compartment are important in driving early protective responses against the virus. Given the current challenges with vaccine access in lower- and middle-income countries (LMIC) as well as varying vaccine acceptance and hesitancy, additional strategies are needed to help curb the spread of SARS-CoV2. There is a need for easily available agents that are low cost and effective at decreasing the effects of SARS-CoV2 exposure. The investigators will evaluate the effectiveness of intranasal Neosporin (which contains neomycin) at inducing interferon responses in human subjects.

This will be a proof of concept that such approach will provide local immune response that could be beneficial against the SARS-CoV2 infection. The potential impact of this study is the utilization of existing and available topical medications for the purpose of providing local prophylaxis against SARS-CoV2.

The overall hypothesis is that neomycin containing agents such as Neosporin when applied topically in the nose can induce local antiviral interferon responses in adult human subjects. Neosporin will be compared to placebo, control Vaseline (Unilever) or equivalent. A run-in cohort of 6 participants to test optimal sampling and storage conditions will be used. The focus of this study is the randomized double-blinded placebo-controlled trial.

The study will enroll an estimated 40 healthy subjects at one study site, Yale University. Local nasal immune responses will be measured using RT-PCR and multiplex ELISA for interferon response. Participants will apply a small amount of the cream (less than a pea size) to the inside of both nostrils, then pinch the nose to spread the cream. Participants will use Neosporin or placebo twice a day for 7 days.

Enrollment: 67 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

Neosporin

Experimental group

Description:

Neosporin will be distributed by the Yale Investigational Pharmacy. Subjects are to use Neosporin twice a day for 7 days.

Treatment:

Drug: Neosporin

Vaseline or equivalent

Placebo Comparator group

Description:

Vaseline or equivalent will be distributed by the Yale Investigational Pharmacy. Subjects are to use Vaseline twice a day for 7 days.

Treatment:

Other: Vaseline