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| ID | Type | Description | Link |
|---|---|---|---|
| INV-038276 | Other Grant/Funding Number | Gates Foundation |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neosporin | Experimental | Neosporin will be distributed by the Yale Investigational Pharmacy. Subjects are to use Neosporin twice a day for 7 days. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Dela Cruz, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C001816 | bacitracin zinc, neomycin sulfate, polymyxin B, drug combination |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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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.
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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).
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| 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. |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |