NCT05449392

Topical Antibacterial Agents for Prevention of COVID-19

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• COVID-19
• SARS-CoV2 Infection

Interventions

Type	Name	Description
DRUG	Neosporin	Neosporin is neomycin, bacitracin and polymyxin B with formulation 3.5mg/400 units/5,000 units. The subject will self-apply a small amount (approximately 0.5 g) of the ointment topically into each nostril (intranasal) twice daily (morning and evening) for seven days. Subjects are to pinch the nose to spread the cream.
OTHER	Vaseline	The subject will self-apply a small amount (approximately 0.5 g) of the ointment topically into each nostril (intranasal) twice daily (morning and evening) for seven days. Subjects are to pinch the nose to spread the cream.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2022-07-08
• Last updated: 2023-10-03

Locations

1 site across 1 country: United States