Topical Antibacterial Agents for Prevention of COVID-19
Condition: COVID-19; SARS-CoV2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Neosporin; Vaseline
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Intervention MeSH terms: Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Neosporin; Antibacterial agent; intranasal application