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New treatment option for Respiratory Viral Infection
Official title Macrophage Regulation of Ozone-Induced Lung Inflammation
ClinicalTrials.gov ID: NCT05773001
What this study is testing
What is Ozone?
Ozone is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for respiratory viral infection.
Also referred to as O3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Individuals between 18-55 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)
- Individuals with knowledge of prior respiratory viral infection history allowing them to be segregated into one of three cohorts
- Cohort 1 - No history of respiratory viral infection (defined as no symptoms consistent with respiratory viral infection nor history of a positive...
- Cohort 2 - Documented mild respiratory viral infection (a positive test, either PCR- or antigen-based) but with mild to no symptoms and no evidence...
- Cohort 3 - History of respiratory viral infection and symptoms/imaging consistent with a lower respiratory tract infection who have recovered, are...
You likely can't join if
- Individuals with prior respiratory viral pneumonia who have ongoing respiratory symptoms, are still using supplemental oxygen, or have abnormal lung...
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- Pregnant women and women who are presently lactating.
- people that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
- Alcohol or illicit substance abuse
See the full eligibility criteria
- Individuals between 18-55 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)
- Individuals with knowledge of prior respiratory viral infection history allowing them to be segregated into one of three cohorts
- Cohort 1 - No history of respiratory viral infection (defined as no symptoms consistent with respiratory viral infection nor history of a positive respiratory viral test)
- Cohort 2 - Documented mild respiratory viral infection (a positive test, either PCR- or antigen-based) but with mild to no symptoms and no evidence of a lower respiratory tract infection (including no hospitalization...
- Cohort 3 - History of respiratory viral infection and symptoms/imaging consistent with a lower respiratory tract infection who have recovered, are \>6 months out from their infection, and have normal lung function...
- There will be no maximal period from respiratory viral infection for inclusion in the study, the minimal period will be \>6 months out from infection
- Individuals with prior respiratory viral pneumonia who have ongoing respiratory symptoms, are still using supplemental oxygen, or have abnormal lung function
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- Pregnant women and women who are presently lactating.
- people that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
- Alcohol or illicit substance abuse
- Chronic cardio/pulmonary respiratory disorders or other medical conditions as determined by the investigator
- Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 \< 4 mg/ml)
- people will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and...
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.