COVID-19Phase 1NCT05449392
Topical Antibacterial Agents for Prevention of COVID-19
A Phase 1 study testing Neosporin and Vaseline in people with COVID-19 and SARS-CoV2 Infection, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV2 Infection
- What is being tested?
- Neosporin and Vaseline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 22 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Neosporin, Vaseline
- Keywords
- Neosporin, Antibacterial agent, intranasal application
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeosporinDrug
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.
VaselineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neosporin | Experimental | Neosporin will be distributed by the Yale Investigational Pharmacy. Subjects are to use Neosporin twice a day for 7 days. Receives: 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. Receives: Other: Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Sep 2022
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Charles Dela Cruz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449392
- Sponsor's protocol ID
- 2000032248
- Other IDs
- INV-038276
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Antibacterial Agents for Prevention of COVID-19
- ClinicalTrials.gov ID
- NCT05449392
- Acronym / sponsor ID
- 2000032248
- Conditions
- COVID-19, SARS-CoV2 Infection
- Keywords
- Neosporin, Antibacterial agent, intranasal application
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neosporin | Experimental | Drug: NeosporinNeosporin will be distributed by the Yale Investigational Pharmacy. Subjects are to use Neosporin twice a day for 7 days. |
| Vaseline or equivalent | Placebo comparator | Other: VaselineVaseline or equivalent will be distributed by the Yale Investigational Pharmacy. Subjects are to use Vaseline twice a day for 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeosporinNeosporin 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. | Drug | Neosporin |
| VaselineThe 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 or equivalent |
Primary outcome
Change in in interferon response profile from nasal samples collected measured by a multiplex ELISA assay
Time frame: From baseline up to Month 1
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
Change in in interferon response gene expression profile from nasal samples collected measured by RT-PCR
Time frame: From baseline up to Month 1
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
Change in RNA expression profile of ISGs using RNAseq assay
Time frame: Day 1and Day 8
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
Change in RNA expression profile of ISGs using single cell RNAseq assay
Time frame: Day 1 and Day 8
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Dela Cruz, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neosporin and Vaseline in people with COVID-19 and SARS-CoV2 Infection, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in in interferon response profile from nasal samples collected measured by a multiplex ELISA assay (time frame: From baseline up to Month 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.