Topical Antibacterial Agents for Prevention of COVID-19

NCT05449392 | Completed Phase 1 DMC

• 2 other identifiers: 2000032248INV-038276
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; SARS-CoV2 Infection

Keywords

Neosporin; Antibacterial agent; intranasal application

Outcome Measures

Primary Outcomes (4)

• Change in in interferon response profile from nasal samples collected measured by a multiplex ELISA assay

  Measurement of interferon response from samples collected using a multiplex ELISA to detect which interferon-stimulated genes (ISGs) are present in sample. ISGs measured include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl

  From baseline up to Month 1

• Change in in interferon response gene expression profile from nasal samples collected measured by RT-PCR

  Measurement of interferon response from samples collected using RT-PCR to detect expression of ISGs. ISGs measured include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl

  From baseline up to Month 1

• Change in RNA expression profile of ISGs using RNAseq assay

  In a subset of subjects in both arms, RNAseq will be performed to assess the presence and quantity of RNA on samples collected at Day 1 and Day 8. ISGs assessed include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl

  Day 1and Day 8

• Change in RNA expression profile of ISGs using single cell RNAseq assay

  In a subset of subjects in both arms, single cell RNAseq will be performed to assess the presence and quantity of RNA on single cells from samples collected at Day 1 and Day 8. ISGs assessed include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl

  Day 1 and Day 8

Study Arms (2)

Neosporin

EXPERIMENTAL

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

Drug: Neosporin

Vaseline or equivalent

PLACEBO COMPARATOR

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

Other: Vaseline

Interventions

Neosporin DRUG

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.

Neosporin

Vaseline OTHER

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.

Vaseline or equivalent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

bacitracin zinc, neomycin sulfate, polymyxin B, drug combination; Petrolatum

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Charles Dela Cruz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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. Each 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. Patient or clinicians requesting unblinding will contact the principal investigator (PI).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 8, 2022
• Study Start: September 1, 2022
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)